{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 102 } }, "results": [ { "effective_time": "20130709", "purpose": [ "Active Ingredients (in each 1 mL dropperful) Purpose Chlorpheniramine Maleate 1 mg Antihistamine Phenylephrine HCl 2 mg Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately." ], "when_using": [ "When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness" ], "questions": [ "Question? Comments? Call 888 9 TRIGEN (888-987-4436)" ], "storage_and_handling": [ "Other Information Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages" ], "set_id": "0571ae18-3f57-4a66-a9bb-e61c3cf07f5f", "id": "17ba4d2c-2ea6-4f07-b41e-385f41d168de", "active_ingredient": [ "Active Ingredients (in each 1 mL dropperful) Purpose Chlorpheniramine Maleate 1 mg Antihistamine Phenylephrine HCl 2 mg Decongestant" ], "dosage_and_administration_table": [ "
Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4 hours not to exceed 12 dropperfuls in 24 hours or as directed by a doctor.
Children under 6 years of age: Consult a physician
" ], "inactive_ingredient": [ "Inactive Ingredients Citric Acid, Glycerin, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose, Vanilla flavor" ], "warnings": [ "Warnings Do not exceed recommended dosage. Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if the child has a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus Ask a doctor before use if the child is taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms persists for more than 1 week, tends to recur, or are accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Trigofen CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN POTASSIUM CITRATE POTASSIUM SORBATE PROPYLPARABEN PROPYLENE GLYCOL WATER SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus Ask a doctor before use if the child is taking sedatives or tranquilizers." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Do not exceed recommended dosage. Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4 hours not to exceed 12 dropperfuls in 24 hours or as directed by a doctor. Children under 6 years of age: Consult a physician" ], "package_label_principal_display_panel_table": [ "
Chlorpheniramine Maleate 1 mg
Phenylephrine HCl 2 mg
" ], "spl_unclassified_section": [ "Drug Facts", "Manufactured for: TRIGEN LABORATORIES" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms persists for more than 1 week, tends to recur, or are accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur" ], "do_not_use": [ "Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product" ], "active_ingredient_table": [ "
Active Ingredients (in each 1 mL dropperful) Purpose
Chlorpheniramine Maleate 1 mg Antihistamine
Phenylephrine HCl 2 mg Decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label NDC 13811- 0081-30 TRIGOFEN DROPS Antihistamine • Decongestant Sugar Free • Alcohol Free • Dye Free Each dropperful (1 mL) for oral administration contains: Chlorpheniramine Maleate 1 mg Phenylephrine HCl 2 mg Orange-Vanilla Flavor 1 fl. Oz. (30 mL) PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label" ], "purpose_table": [ "
Active Ingredients (in each 1 mL dropperful) Purpose
Chlorpheniramine Maleate 1 mg Antihistamine
Phenylephrine HCl 2 mg Decongestant
" ] }, { "effective_time": "20120830", "inactive_ingredient": [ "Inactive ingredients Water, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Glycerin, Silica, Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Dimethyl Capramide, Hydrogenated Palm Glycerides, Polysiloxane 11, Dimethylmethoxy Chromanol, Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, Diaminopropionoyl Tripeptide-33, Caprylyl Glycol, Disodium EDTA, Xanthan Gum, Methylisothiazolinone, Hexylene Glycol, Isohexadecane, Polysorbate 80, Vitis Vinifera Fruit Cell Extract, Isomalt, Prunus Armeniaca (Apricot) Fruit Extract, Lecithin, Sodium Benzoate, Aniba Rosaeodora (Rosewood) Wood Extract, Citrus Aurantifolia (Lime) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Vanilla Planifolia Fruit Extract, Citrus Grandis (Grapefruit) Peel Extract, Cocos Nucifera (Coconut) Oil" ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings For external use only When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free (800) 630-4710" ], "spl_product_data_elements": [ "Light Day Sunscreen Broad Spectrum SPF 37 Avobenzone, Octinoxate and Octocrylene AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE WATER ALKYL (C12-15) BENZOATE GLYCERIN SILICON DIOXIDE GLYCERYL MONOSTEARATE PEG-100 STEARATE POTASSIUM CETYL PHOSPHATE DIMETHICONE CYCLOMETHICONE 5 CYCLOMETHICONE 6 DIMETHYL CAPRAMIDE HYDROGENATED PALM GLYCERIDES SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) CAPRYLYL GLYCOL EDETATE DISODIUM XANTHAN GUM METHYLISOTHIAZOLINONE HEXYLENE GLYCOL ISOHEXADECANE POLYSORBATE 80 ISOMALT APRICOT SODIUM BENZOATE ANIBA ROSAEODORA WOOD LIME PEEL ORANGE PEEL VANILLA CITRUS MAXIMA FRUIT RIND COCONUT OIL EGG PHOSPHOLIPIDS WINE GRAPE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply liberally to skin 15 minutes before sun exposure and as needed. use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours. children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirt, pants, hats, and sunglasses" ], "spl_unclassified_section": [ "Other Information protect this product from excessive heat and direct sun." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Light Day Sunscreen for face & neck Broad Spectrum SPF37 Advanced Professional Skincare 2 fl oz (59 ml) Circadia by Dr. Pugliese, Inc. 8371 Route 183 Bethel, PA 19507 Circadia.com Bottle Label Bottle Label" ], "indications_and_usage": [ "Uses Helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "05a63c49-1974-4b26-b070-b32813cb0852", "id": "05a63c49-1974-4b26-b070-b32813cb0852", "active_ingredient": [ "Active ingredient Avobenzone 3.0% Octinoxate 7.5% Octocrylene 2.8%" ] }, { "effective_time": "20131016", "inactive_ingredient": [ "Inactive Ingredients: Deionized water Fructose Natural Cherry flavor Vanilla flavor Natural color Citric acid Potassium Benzoate Xanthan gum" ], "purpose": [ "Homeopathic cough syrup for kids and teens" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "In case of overdose get medical help or contact poison control center right away A persistent cough may be a sign of a serious condition If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician Do not give this product for persistent or chronic cough associate with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician As with any medicine, if you are pregnant, may become pregnant, or breasfeeding, seek the advice of a health care professional before using this product" ], "spl_product_data_elements": [ "Wellness with Cherry Flavor Cough Syrup Althaea officinalis, Prunus virginiana, Inula helenium ALTHAEA OFFICINALIS ROOT ALTHAEA OFFICINALIS ROOT PRUNUS VIRGINIANA BARK PRUNUS VIRGINIANA BARK INULA HELENIUM ROOT INULA HELENIUM ROOT MARRUBIUM VULGARE MARRUBIUM VULGARE EUCALYPTUS GLOBULUS LEAF EUCALYPTUS GLOBULUS LEAF RUMEX CRISPUS ROOT RUMEX CRISPUS ROOT SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT BRYONIA ALBA WHOLE BRYONIA ALBA WHOLE CAUSTICUM CAUSTICUM STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PHOSPHORUS PHOSPHORUS Anemone nemorosa Anemone nemorosa WATER FRUCTOSE CHERRY JUICE VANILLA NATURAL RED 26 CITRIC ACID MONOHYDRATE POTASSIUM BENZOATE XANTHAN GUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Adults and children 12 years of age and older: Take 2 teaspoons every 4 hours Or as needed Children 2 - 12 years of age: Take 1 teaspoon every 4 hours Or as needed Children under 2: Consult a physician for use" ], "package_label_principal_display_panel": [ "bottle image jpeg bottlelabel/.jpg image of label" ], "indications_and_usage": [ "For the temporary relief of coughs and congestion due to cold and flu. Helps loosen mucus (expectorant) and clear bronchial congestion. Soothes sore throat. For best Results: Keep mouth free of food and strong tastes for 15 minutes before and after taking. Hold liquid in mouth for 10-15 seconds before swallowing." ], "set_id": "09a40163-abc8-45df-baf5-aff076cc8377", "id": "567f8229-f7e2-415b-b687-7769befa0f92", "active_ingredient": [ "Active Ingredients: Althaea officinalis 1x Prunus virginiana 1x Inula helenium 3x Marrubium vulgare 3x Eucalyptus globulus 6x Rumex crispus 6x Sanguinaria canadensis 6x Bryonia alba 12x Causticum 12x Nux vomica 12x Phosphorus 12x Pulsatilla nigricans 12x" ] }, { "effective_time": "20120229", "inactive_ingredient": [ "Inactive Ingredients: Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Carthamus tinctorius (Safflower) seed oil, Castor Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Medica Limonum (Lemon) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Methyl Abietate, Magnesium Sulfate, Polyaminopropyl Biguanide, Polyglyceryl-10 Laurate, Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Stearate, Tocopherol, Vanilla Planifolia (Vanilla) Fruit Extract, Water" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only Do not use on damaged or broken skin" ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or Comments? Please Call 1-800-221-0131" ], "spl_product_data_elements": [ "Green Babies Inc. SPF 30 Sunscreen sweetly scented with tangerine essential oil Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES SAFFLOWER OIL CASTOR OIL ORANGE OIL GRAPEFRUIT OIL LEMON OIL MANDARIN OIL SUNFLOWER OIL MAGNESIUM SULFATE POLYAMINOPROPYL BIGUANIDE JOJOBA OIL SORBITAN MONOSTEARATE TOCOPHEROL VANILLA WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun especially from 10 a.m.- 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses." ], "stop_use": [ "Stop use and ask doctor if rash occurs" ], "storage_and_handling": [ "Other Information protect this product from excessive heat and direct sunlight" ], "package_label_principal_display_panel": [ "Image of Label GreenBabiesSPF30TangerineLabel.jpg Label" ], "indications_and_usage": [ "Uses helps prevent sunburn" ], "set_id": "0a852b90-f7f5-4497-8129-a56ae8a1673c", "id": "7769c8a4-f29f-4f87-b835-f63892469796", "active_ingredient": [ "Active Ingredient Zinc Oxide 20%" ] }, { "effective_time": "20100111", "inactive_ingredient": [ "Inactive ingredients Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid, Vanilla Flavor." ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use for children under 12 years of age unless directed by a doctor Do not take unless directed by a doctor if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-800-344-7239 or visit us on the web at www.insightpharma.com" ], "spl_product_data_elements": [ "Bonine meclizine hydrochloride meclizine hydrochloride meclizine crospovidone FD&C Red No. 40 Aluminum Oxide Lactose Magnesium Stearate Silicon Dioxide Saccharin Sodium stearic acid Croscarmellose Sodium light pink Bonine;201" ], "ask_doctor": [ "Do not take unless directed by a doctor if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions dosage should be taken one hour before travel starts adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749" ], "storage_and_handling": [ "Other information store at room temperature 20°– 25°C (68°–77°F)" ], "do_not_use": [ "Do not use for children under 12 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 8 Tablet Carton BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC Prevents Motion Sickness Chewable Once-A-Day Protection 8 Tablets PRINCIPAL DISPLAY PANEL - 8 Tablet Carton" ], "indications_and_usage": [ "Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness" ], "set_id": "0b4b55cd-063e-4d0e-911c-8e03886e15d3", "id": "82885c3d-4964-44dd-8bb6-fe55afab3ce7", "active_ingredient": [ "Active ingredient (in each tablet) Meclizine HCl 25 mg" ] }, { "effective_time": "20141118", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE (PARFUM), VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, RETINYL PALMITATE, IRON OXIDES (CI 77491), TITANIUM DIOXIDE (CI 77891), RED 33 (CI 17200)" ], "purpose": [ "PURPOSE ANTISEPTIC" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "questions": [ "QUESTIONS/COMMENTS? 1-866-695-3030" ], "spl_product_data_elements": [ "ORCHID ANTIBACTERIAL VANILLA AND APPLE BLOSSOM ETHYL ALCOHOL ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL GLYCERIN ISOPROPYL MYRISTATE AMINOMETHYLPROPANOL CARBOMER 934 .ALPHA.-TOCOPHEROL ACETATE VANILLA APPLE ALOE VERA LEAF MANNITOL POWDERED CELLULOSE HYPROMELLOSES VITAMIN A PALMITATE FERRIC OXIDE RED TITANIUM DIOXIDE D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "storage_and_handling": [ "OTHER INFORMATION STORE AT A TEMPERATURE BELOW 110°F (43°C)" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE BACTERIA ON THE SKIN" ], "set_id": "0bccb2d6-e701-4982-9a66-357eb42758af", "id": "24273bb8-9f20-4002-8094-a5640daa0650", "active_ingredient": [ "ACTIVE INGREDIENT ETHYL ALCOHOL 62% PURPOSE ANTISEPTIC" ] }, { "effective_time": "20110124", "inactive_ingredient": [ "Inactive Ingredients Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." ], "when_using": [ "When using this product Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "SnowSkin GolfersSkin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL LANOLIN .ALPHA.-TOCOPHEROL ACETATE, DL- VANILLA" ], "description": [ "Golfers Skin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera To report a serious adverse event, contact 1-800-332-1088 Expires: Lot Number: www.golfersskin.co DIST. BY Quiver Dist, Bend Oregon, USA 97701 AS/ANZ STANDARD 2604-1998 Tested on Golfers - Not Animals Net Wt. .3oz (8.5g)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions Apply generously 15 mins before sun exposure and as needed Children under 6 months of age; ask a doctor Reapply as needed or after towel drying, swimming or sweating." ], "stop_use": [ "Stop use and ask a doctor if irritation occurs or rash develops ad lasts." ], "package_label_principal_display_panel": [ "SPF 30+ very water / sweat resistant broad spectrum UVA/UVB protection Proven in extreme New Zealand conditions Golfers Skin sunscreen lip balm Net Wt. .30 oz (8.5g) contains no nanoparticles - aminobenzoic acid (PABA)-free", "Golfers Skin Lip Balm", "Golfer Skin Sunscreen" ], "indications_and_usage": [ "Uses Helps prevent sunburn Higher SPF gives more sunburn protection Provides high protection against sunburn Regains SPF after 80 minutes of sweating." ], "set_id": "11e533ae-0653-458c-8c58-49b1269e01a8", "id": "508fee43-0288-4f79-9c4f-ca262b549c64", "active_ingredient": [ "Active Ingredients Avobenzone 2.5% Octinoxate 7.5% Octocrylene 5.0%" ] }, { "effective_time": "20150817", "inactive_ingredient": [ "Inactive ingredients ricinus communis (castor) seed oil, oleic/linoleic/linolenic polyglycerides, beeswax, simmondsia chinensis (jojoba) seed oil, flavor, silica, lecithin, jojoba esters, polyhydroxystearic acid, tocopherol [vitamin E], vanilla planifolia fruit extract, carmine, iron oxides, mica, titanium dioxide" ], "purpose": [ "Purpose Zinc oxide - Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Stop use and ask doctor if • rash or irritation develops and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com" ], "spl_product_data_elements": [ "Softlips Pure Lip Gloss Coral zinc oxide ZINC OXIDE ZINC OXIDE WHITE WAX" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply liberally before sun exposure and as needed • children under 6 months of age: ask a doctor" ], "stop_use": [ "Stop use and ask doctor if • rash or irritation develops and lasts" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Softlips Pure Coral Charm Sheer Lip Gloss Color inspired by nature 100% natural Softlips Pure Coral Charm Sheer Lip Gloss Color Inspired By Nature 100% Natural" ], "indications_and_usage": [ "Uses • helps prevent sunburn • provides UVA and UVB protection" ], "set_id": "132fe065-4453-41c0-8c0f-01f193e5978d", "id": "b5217e25-94ef-4cca-8041-86e3bdfc5733", "active_ingredient": [ "Active ingredient Zinc oxide 6.5%" ] }, { "effective_time": "20130823", "inactive_ingredient": [ "Inactive ingredients: (Vanilla) wax, isopropyl myristate, mineral oil, flavor, saccharin, iron oxides, D&C yellow no. 10 aluminum lake, lecithin, hydrogenated vegetable oil", "Inactive Ingredients: (Regular) wax, isopropyl myristate, mineral oil, camphor, iron oxides, lecithin, hydrogenated vegetable oil", "Inactive Ingredients: (Mint) wax, isopropyl myristate, mineral oil, flavor, FD&C blue no. 2 aluminum lake, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, lecithin, hydrogenated vegetable oil, saccharin", "Inactive Ingredients: (Cherry) wax, isopropyl myristate, mineral oil, flavors, D&C red no. 27 aluminum lake, lecithin, hydrogenated vegetable oil", "Inactive Ingredients (Bubble Gum) wax, isopropyl myristate, mineral oil, flavors, saccharin, D&C red no. 27 aluminum lake, lecithin, hydrogenated vegetable oil" ], "purpose": [ "Use: Helps prevent, protect, and relieve chapped lips" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings: For external use only. Stop use and ask a doctor if condition lasts more than 7 days." ], "questions": [ "Questions? call toll-free 1-866-255-5202 weekdays" ], "spl_product_data_elements": [ "CHAP-ET white petrolatum PETROLATUM PETROLATUM CERESIN ISOPROPYL MYRISTATE MINERAL OIL SACCHARIN D&C YELLOW NO. 10 ALUMINUM OXIDE LECITHIN, SOYBEAN pale yellow CHAP-ET white petrolatum PETROLATUM PETROLATUM CERESIN ISOPROPYL MYRISTATE MINERAL OIL CAMPHOR (NATURAL) LECITHIN, SOYBEAN off white CHAP-ET white petrolatum PETROLATUM PETROLATUM CERESIN ISOPROPYL MYRISTATE MINERAL OIL FD&C BLUE NO. 2 D&C YELLOW NO. 10 FD&C BLUE NO. 1 ALUMINUM OXIDE LECITHIN, SOYBEAN SACCHARIN pale green CHAP-ET white petrolatum PETROLATUM PETROLATUM CERESIN ISOPROPYL MYRISTATE MINERAL OIL D&C RED NO. 27 ALUMINUM OXIDE LECITHIN, SOYBEAN cherry CHAP-ET white petrolatum PETROLATUM PETROLATUM CERESIN ISOPROPYL MYRISTATE MINERAL OIL SACCHARIN D&C RED NO. 27 ALUMINUM OXIDE LECITHIN, SOYBEAN" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions: apply as needed" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0495-01 chap•et ® Vanilla LIP BALM SKIN PROTECTANT Silky smooth formula moisturizes and protects dry and chapped lips. Sealed Twist-Off Cap Do Not Use If Seal Is Broken NET WT .16 OZ (4.5g) Distributed By: GlaxoSmithKline Consumer Healthcare, L.P. Moon Twp, PA 15108 ©2009 GlaxoSmithKline 62137XA Chap Et Vanilla Label", "Principal Display Panel NDC 0135-0493-01 chap•et ® Regular LIP BALM SKIN PROTECTANT Silky smooth formula moisturizes and protects dry and chapped lips. Sealed Twist-Off Cap Do Not Use If Seal Is Broken NET WT .16 OZ (4.5g) Distributed By: GlaxoSmithKline Consumer Healthcare, L.P. Moon Twp, PA 15108 ©2009 GlaxoSmithKline 62135XA Chap Et Regular Label", "Principal Display Panel NDC 0135-0496-01 chap•et ® Mint LIP BALM SKIN PROTECTANT Silky smooth formula moisturizes and protects dry and chapped lips. Sealed Twist-Off Cap Do Not Use If Seal Is Broken NET WT .16 OZ (4.5g) Distributed By: GlaxoSmithKline Consumer Healthcare, L.P. Moon Twp, PA 15108 ©2009 GlaxoSmithKline 62136XA Chap Et Mint Label", "Principal Display Panel NDC 0135-0494-01 chap•et ® Cherry LIP BALM SKIN PROTECTANT Silky smooth formula moisturizes and protects dry and chapped lips. Sealed Twist-Off Cap Do Not Use If Seal Is Broken NET WT .16 OZ (4.5g) Distributed By: GlaxoSmithKline Consumer Healthcare, L.P. Moon Twp, PA 15108 ©2009 GlaxoSmithKline 62133XA Chap Et Cherry Label", "Principal Display Panel NDC 0135-0497-01 chap•et ® Bubble Gum LIP BALM SKIN PROTECTANT Silky smooth formula moisturizes and protects dry and chapped lips. Sealed Twist-Off Cap Do Not Use If Seal Is Broken NET WT .16 OZ (4.5g) Distributed By: GlaxoSmithKline Consumer Healthcare, L.P. Moon Twp, PA 15108 ©2009 GlaxoSmithKline 62134XA Chap Et Bubble Gum Label" ], "indications_and_usage": [ "" ], "set_id": "13e22f0a-0887-4b8d-ba1d-289649424962", "id": "56d11a15-e70b-4c7f-a034-cc8efcb73714", "active_ingredient": [ "Active ingredient: White Petrolatum 61.93% w/w" ] }, { "effective_time": "20090831", "inactive_ingredient": [ "Inactive Ingredients Water (Aqua), Petrolatum, Mineral Oil (Parraffinum Liquidum),Glycerin, Stearic Acid, Glycol Stearate, Glyceryl Stearate, Triethanolamine, PEG-40 Stearate, Cetyl Alcohol, DMDM Hydantoin, Magnesium Aluminum Silicate, Methylparaben, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Acetylated Lanolin Alcohol, Carbomer, Propylparaben, Disodium EDTA, Geranium Maculatum Oil, Lecithin, Borago Officinalis Seed Oil, Cholesterol, Ascorbyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ethylene Brassylate, Santalum Album (Sandalwood) Oil, Rosa Damascena Extract, Vanilla Planifolia Fruit Extract" ], "purpose": [ "Purpose Skin Protectant" ], "warnings": [ "Warnings For external use only. Do not get into eyes. Stop use and ask a doctor if : Condition worsens, Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away." ], "spl_product_data_elements": [ "Dermasil Dry Skin Lotion Treatment Lotion Dimethicone DIMETHICONE DIMETHICONE WATER PETROLATUM MINERAL OIL GLYCERIN STEARIC ACID GLYCOL STEARATE GLYCERYL MONOSTEARATE CETYL ALCOHOL MAGNESIUM ALUMINUM SILICATE METHYLPARABEN HELIANTHUS ANNUUS CETYLPYRIDINIUM ACETATE CARBOMER HOMOPOLYMER TYPE C PROPYLPARABEN EDETATE DISODIUM LECITHIN, SOYBEAN BORAGE CHOLESTEROL ASCORBYL PALMITATE ALMOND VANILLA GERANIUM EXTRACT" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply as needed" ], "spl_unclassified_section": [ "Dermasil ® Labs has developed Dermasil ® OTC pharmaceuticals skincare, a powerful dry skin treatment and skin protectant. This lotion contains four systems to control and provide long-lasting relief from severe dry skin: Occlusives to block moisture loss from the skin's surface Humectant to bind water in the skin's outermost layers Skin Lipids to enhance the skin's natural ability to retain moisture EFA's an important component of the skin's moisture barrier", "Drug Facts Active Ingredient Dimethicone 1 % Purpose Skin Protectant Uses • Temporarily protects and helps relieve chapped or cracked skin. • Helps protect from the drying effects of wind and cold weather. Warnings For external use only. Do not get into eyes. Stop use and ask a doctor if : Condition worsens, Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away. Directions Apply as needed Inactive Ingredients Water (Aqua), Petrolatum, Mineral Oil (Parraffinum Liquidum),Glycerin, Stearic Acid, Glycol Stearate, Glyceryl Stearate, Triethanolamine, PEG-40 Stearate, Cetyl Alcohol, DMDM Hydantoin, Magnesium Aluminum Silicate, Methylparaben, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Acetylated Lanolin Alcohol, Carbomer, Propylparaben, Disodium EDTA, Geranium Maculatum Oil, Lecithin, Borago Officinalis Seed Oil, Cholesterol, Ascorbyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ethylene Brassylate, Santalum Album (Sandalwood) Oil, Rosa Damascena Extract, Vanilla Planifolia Fruit Extract" ], "package_label_principal_display_panel": [ "Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml) Tube Label Dermasil 10oz 25% MORE Dermasil ® LABS Pharmaceutical Research Controls Even Severe Dry Skin Skin Lipid & EFA Treatment Hypo-Allergenic Dermasil ® Dry Skin Treatment ORIGINAL LOTION 10 FL.0Z (5/8 PINT. 296 ml) Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)" ], "indications_and_usage": [ "Indications: Suitable for severe dry skin, and control of symptoms such as chapping, cracking, flaking, roughness, redness, soreness, and the itching associated with dry skin.", "Uses • Temporarily protects and helps relieve chapped or cracked skin. • Helps protect from the drying effects of wind and cold weather." ], "set_id": "146de66b-638e-432a-b1b9-60cd8a2a8bd8", "id": "0914f6f0-9d72-496d-aeab-1ed01c6fb94b", "active_ingredient": [ "Active Ingredient Dimethicone 1 %" ] }, { "effective_time": "20140130", "inactive_ingredient": [ "Inactive Ingredients: Ricinus Communis (Castor) Seed Oil, Hydrogenated Coconut Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Vanilla Planifolia Extract,Ammonium Glycyrrhizate, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil." ], "instructions_for_use": [ "Directions • Apply liberally 15 minutes before sun exposure. • reapply this product at least every 2 hours. • use water resistant sunscreen if swimming or sweating. • children under 6 months of age: ask a doctor." ], "purpose": [ "Purpose Sunscreen Sunscreen" ], "precautions": [ "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings • Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, skin cancer or early skin aging. • For external use only. Don not use • on damaged or broken skin." ], "when_using": [ "When using this product • keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "LIP CARE SPF 15 WITH VITAMIN E Octinoxate, Oxybenzone OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE CASTOR OIL COCONUT OIL OLIVE OIL YELLOW WAX CANDELILLA WAX MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL AMMONIUM GLYCYRRHIZATE VANILLA CALENDULA OFFICINALIS FLOWER ECHINACEA PURPUREA SOYBEAN OIL TOCOPHEROL BUTYLATED HYDROXYTOLUENE" ], "warnings_and_cautions": [ "Drug Facts" ], "ask_doctor": [ "Stop use and ask a doctor if • rash occurs." ], "other_safety_information": [ "Other information • protect the product in this container from excessive heat and direct sun." ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "Principal Display Panel Image Components Component Artwork" ], "indications_and_usage": [ "Uses • Helps prevent sunburn" ], "set_id": "14e6dc52-045d-45ca-9633-16fa244d1a68", "id": "3153033b-7552-4484-a4db-f403330ef2ee", "active_ingredient": [ "Active Ingredient Octinoxate (7.5% w/w) Oxybenzone (5.0% w/w)" ] }, { "effective_time": "20130315", "inactive_ingredient": [ "Inactive ingredients WATER/EAU, SODIUM LAURETH SULFATE, GLYCERIN, COCAMIDE MEA, COCAMIDOPROPYL BETAINE, RUBUS FRUTICOSUS (BLACKBERRY) FRUIT EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, SODIUM CHLORIDE, PARFUM/FRAGRANCE, POLYSORBATE 20, DISODIUM EDTA, PEG-150 DISTEARATE, BENZOPHENONE-3, PHOSPHORIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4/CI 14700, BLUE 1/CI 42090, RED 33/CI 17200." ], "purpose": [ "Purpose ....................Antiseptic handwash" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only When using this product: Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a health care practitioner if • irritation and redness develop Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product: Avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "questions": [ "QUESTIONS? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada" ], "spl_product_data_elements": [ "Naturals Blackberry and Vanilla Anti-Bacterial Hand Triclosan TRICLOSAN TRICLOSAN" ], "ask_doctor": [ "Stop use and ask a health care practitioner if • irritation and redness develop" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • Pump a generous amount of soap onto wet hands and work into a rich lather. Wash, rinse and dry thoroughly. • Use as part of daily cleansing routine." ], "package_label_principal_display_panel": [ "image of PDP image of back label image of back label" ], "indications_and_usage": [ "Uses • for handwashing to decrease certain bacteria on the skin" ], "set_id": "15ba3f41-3045-42cd-b169-59dc16ff6746", "id": "f17c422a-017e-4f27-8162-b01ad47245a4", "active_ingredient": [ "Active ingredient Triclosan 0.2%................ Purpose ....................Antiseptic handwash" ] }, { "effective_time": "20151002", "inactive_ingredient": [ "Inactive Ingredients CYCLOPENTASILOXANE, PEG-10 DIMETHICONE, DIMETHICONE/METHICONE COPOLYMER, WATER, HEXYL LAURATE, METHICONE, ALUMINA, BUTYLENE GLYCOL, CYCLOMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIPROPYLENE GLYCOL, NYLON-12, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HYDROGEN DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, PANTHENOL, MAGNESIUM SULFATE, DISTEARDIMONIUM HECTORITE, PROPANEDIOL, CAPRYLHYDROXAMIC ACID, SORBITAN SESQUIOLEATE, ZINC STEARATE, CAPRYLIC/CAPRIC GLYCERIDES, TRIMETHYLSILOXYSILICATE, DISTEARYLDIMONIUM CHLORIDE, DIPOTASSIUM GLYCYRRHIZATE, VP/EICOSENE COPOLYMER, ALANYL GLUTAMINE, VANILLA TAHITENSIS FRUIT EXTRACT, ADENOSINE, TRISODIUM EDTA, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, SODIUM BENZOATE, TOCOPHERYL ACETATE, MENTHYL PCA, SODIUM PCA, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), MICA (CI 77019), IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen", "Uses Helps prevent sunburn." ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Apply an adequate amount on the face and neck at the final stage of skincare." ], "questions": [ "Questions or comments? Call 1-866-638-8417" ], "spl_product_data_elements": [ "NATURAL SUN ECO Power Long-lasting Sunscreen Cream SPF50 octinoxate, octisalate and zinc oxide cream ZINC OXIDE ZINC OXIDE OCTISALATE OCTISALATE WATER OCTINOXATE OCTINOXATE" ], "other_safety_information": [ "Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "NATURAL SUN ECO Power Long-lasting Sunscreen Cream SPF 50+ Contains sunflower sprout extract 600 µg A premium sun cream without stickiness, protects the skin from sun rays and also works as makeup base. Label" ], "set_id": "2123e4cd-5c43-2748-e054-00144ff8d46c", "id": "2123e4cd-5c44-2748-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Octinoxate 7.2 % Octisalate 2.0 % Zinc Oxide 12.0 %" ] }, { "effective_time": "20101220", "inactive_ingredient": [ "Inactive ingredients: WATER/EAU SODIUM LAURETH SULFATE KAOLIN COCAMIDE MEA GLYCOL STEARATE SODIUM COCO-SULFATE HYDROGENATED CASTOR OIL PYRUS MALUS (APPLE) JUICE VANILLA PLANIFOLIA FRUIT EXTRACT ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT CINNAMOMUM CASSIA BARK EXTRACT CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT PEG-40 HYDROGENATED CASTOR OIL POLYETHYLENE BUTYLENE GLYCOL SHEA BUTTERAMIDOPROPYL BETAINE SD ALCOHOL 40-B METHYLPARABEN DISODIUM EDTA GLYCINE SOJA (SOYBEAN) OIL HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL HYDRATED SILICA PHOSPHORIC ACID CAPRYLIC/CAPRIC TRIGLYCERIDE ISOPROPYL MYRISTATE DIPROPYLENE GLYCOL HEXYLENE GLYCOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE TITANIUM DIOXIDE/CI 77891" ], "purpose": [ "Purpose .....................Acne Treatment" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only When using this product avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists, seek medical attention. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical medication at a time. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists, seek medical attention. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical medication at a time." ], "questions": [ "Questions? Call 1-800-MEET-MARK image of PDP image of DFB" ], "spl_product_data_elements": [ "mark. Help Wanted Anti-Acne Exfoliating Cleanser Salicylic Acid SALICYLIC ACID SALICYLIC ACID WATER SODIUM LAURETH SULFATE KAOLIN GLYCOL STEARATE HYDROGENATED CASTOR OIL BUTYLENE GLYCOL METHYLPARABEN HYDRATED SILICA PHOSPHORIC ACID DIPROPYLENE GLYCOL HEXYLENE GLYCOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE TITANIUM DIOXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions wet hands and face with warm water pour into hands and work into a lather gently massage into skin in a circular motion, avoiding the eye area rinse and pat dry. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor if bothersome dryness, irritation or peeling occurs, reduce application to every other day" ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses for the treatment of acne helps clear up acne blemishes helps prevent new acne blemishes from forming penetrates pores to eliminate most blackheads and acne pimples" ], "set_id": "233b39a9-aafb-44bc-b0b2-06fd4c646cea", "id": "5f7394a9-b67b-43ec-b132-26d555cab7ce", "active_ingredient": [ "Active ingredient Salicylic Acid 0.5%................. Purpose .....................Acne Treatment" ] }, { "effective_time": "20150817", "inactive_ingredient": [ "Inactive ingredients ricinus communis (castor) seed oil, oleic/linoleic/linolenic polyglycerides, beeswax, simmondsia chinensis (jojoba) seed oil, flavor, silica, lecithin, jojoba esters, polyhydroxystearic acid, tocopherol [vitamin E], vanilla planifolia fruit extract, carmine, mica, titanium dioxide" ], "purpose": [ "Purpose Zinc oxide - Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Stop use and ask doctor if • rash or irritation develops and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com" ], "spl_product_data_elements": [ "Softlips Pure Lip Gloss Pink zinc oxide ZINC OXIDE ZINC OXIDE WHITE WAX" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply liberally before sun exposure and as needed • children under 6 months of age: ask a doctor" ], "stop_use": [ "Stop use and ask doctor if • rash or irritation develops and lasts" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Softlips Pure Shell Pink Sheer Lip Gloss Color inspired by nature 100% natural Softlips Pure Shell Pink Sheer Lip Gloss Color Inspired By Nature 100% natural" ], "indications_and_usage": [ "Uses • helps prevent sunburn • provides UVA and UVB protection" ], "set_id": "23ef354e-f5f3-49f2-9ca6-11dadf533c2d", "id": "ea12f10f-c091-4886-b159-c547f0c59214", "active_ingredient": [ "Active ingredient Zinc oxide 6.5%" ] }, { "effective_time": "20150115", "inactive_ingredient": [ "WATER (AQUA), SODIUM LAURETH SULFATE, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYLAMINE OXIDE, PPG-1-PEG-9 LAURYL GLYCOL ETHER, FRAGRANCE (PARFUM), PEG-7 GLYCERYL COCOATE, BENZOPHENONE-4, GLYCERIN, TETRASODIUM EDTA, SODIUM CHLORIDE, BENZYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, VANILLA PLANIFOLIA FRUIT EXTRACT, PROPYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM HYDROXIDE, METHYCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)" ], "purpose": [ "PURPOSE ANTIBACTERIAL" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "AURORA ANTIBACTERIAL VANILLA BROWN SUGAR TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE DISODIUM LAURETH SULFOSUCCINATE COCAMIDOPROPYLAMINE OXIDE PPG-1-PEG-9 LAURYL GLYCOL ETHER PEG-7 GLYCERYL COCOATE SULISOBENZONE GLYCERIN EDETATE SODIUM SODIUM CHLORIDE BENZYL ALCOHOL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) GREEN TEA LEAF ALOE VERA LEAF VANILLA PROPYLENE GLYCOL HYPROMELLOSES CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY TO DRY HANDS, WORK INTO A RICH FOAMY LATHER AND RINSE THOROUGHLY" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "storage_and_handling": [ "OTHER INFORMATION STORE ST ROOM TEMPERATURE" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES FOR WASHING TO DECREASE BACTERIA ON THE SKIN" ], "set_id": "2475a362-f9ef-4dd8-98de-af68c3134b0f", "id": "9a1a78ec-d482-4a2a-b1fa-2500cf1ace64", "active_ingredient": [ "ACTIVE INGREDIENT TRICLOSAN 0.3% PURPOSE ANTIBACTERIAL" ] }, { "effective_time": "20110909", "purpose": [ "Purpose Antihistamine Antitussive (Cough Suppressant) Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? Comments? Call (630) 543-3333 Rx Only CV Manufactured for: RESPA ® PHARMACEUTICALS, INC. Addison, IL 60101" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information Store at 15°- 30°C (59°- 86°F)" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages" ], "set_id": "2548c67a-dfff-4cfb-8f51-a1006cf54a2f", "id": "cfbbbfc0-ceb1-42b7-927b-6dcc58e30f1f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Drug Facts Active ingredients (in each 5 mL teaspoonful) Chlorpheniramine Maleate 2 mg Codeine Phosphate* 8 mg *WARNING: May be habit forming Pseudoephedrine Hydrochloride 30 mg" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in a 24 hour period
Children under 6 years of age: Consult a doctor.
" ], "inactive_ingredient": [ "Inactive ingredients Berry Vanilla Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol." ], "warnings": [ "Warnings Do not exceed recommended dosage." ], "spl_product_data_elements": [ "Tricode AR Chlorpheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride Chlorpheniramine Maleate Chlorpheniramine Codeine Phosphate Codeine Pseudoephedrine Hydrochloride Pseudoephedrine Citric Acid Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) chronic pulmonary disease or shortness of breath, or children who are taking other drugs heart disease high blood pressure thyroid disease diabetes" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in a 24 hour period Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in a 24 hour period Children under 6 years of age: Consult a doctor. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child." ], "stop_use": [ "Stop use and ask a doctor if cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. may cause or aggravate constipation nervousness, dizziness, or sleeplessness occur new symptoms occur" ], "do_not_use": [ "Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product" ], "package_label_principal_display_panel": [ "Product Packaging The packaging below represents the labeling currently used: Principal display panel and side panel for 473 mL label: NDC 60575-313-16 ____________________________________________ Tricode AR ® Antihistamine·Cough Suppressant Nasal Decongestant ____________________________________________ Each 5 mL (one teaspoonful) for oral administration contains: Chlorpheniramine Maleate.................................2 mg Codeine Phosphate*.........................................8 mg *(Warning: May be habit-forming) Pseudoephedrine HCl......................................30 mg Dye Free / Sugar Free Alcohol Free / Gluten Free Berry Vanilla Flavor Rx Only RESPA ® PHARMACEUTICALS, INC. Addison, IL 60101 16 fl oz. (473 mL) SEE ATTACHED PRODUCT INSERT FOR COMPLETE DOSING INFORMATION. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature, 15°- 30°C (59°- 86°F). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Respa Pharmaceuticals Addision, IL 60101 Rx Only Rev. 08/11 Tricode AR Packaging Tricode AR Packaging" ] }, { "effective_time": "20120628", "inactive_ingredient": [ "Inactive ingredients (Ocean Breeze) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, and Ultramarines", "Inactive ingredients (Cherry Blossom) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5", "Inactive ingredients (Red Pomegranate) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5", "Inactive ingredients (Dark Raspberry) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5", "Inactive ingredients (Warm Vanilla Sugar) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5" ], "purpose": [ "Purpose Anti-bacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Flammable, keep away from fire or flame. Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. If contact occurs, rinse thoroughly with water. Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor." ], "questions": [ "QUESTIONS? 1-800-FDA-1088" ], "spl_product_data_elements": [ "Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C BLUE NO. 1 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply to hands until thoroughly wet. Rub vigorously until dry. Supervise children in the use of this product." ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Ocean Breeze anti-bacterial hand gel 1 fl. oz. Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Ocean Breeze Principal Display Panel - Ocean Breeze", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Cherry Blossom anti-bacterial hand gel 1 fl. oz. Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Cherry Blossom Principal Display Panel - Cherry Blossom", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Red Pomegranate anti-bacterial hand gel 1 fl. oz. Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Red Pomegranate Principal Display Panel - Red Pomegranate", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Dark Raspberry anti-bacterial hand gel 1 fl. oz. Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Dark Raspberry Principal Display Panel - Dark Raspberry", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Warm Vanilla Sugar anti-bacterial hand gel 1 fl. oz. Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Warm Vanilla Sugar Principal Display Panel - Warm Vanilla Sugar" ], "indications_and_usage": [ "Use To decrease bacteria on the skin and clean hands. Recommended for repeated use." ], "set_id": "25b02f75-73d9-4590-b020-5fd488a05328", "id": "25b02f75-73d9-4590-b020-5fd488a05328", "active_ingredient": [ "Active Ingredient Ethyl Alcohol 62% w/w" ] }, { "effective_time": "20120822", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients: Talc, Methicone, Aluminum Starch Octenylsuccinate, Dimethicone, Iron Oxides, Mica, Methylparaben, Montmorillonite, Propylparaben, Fragrance, Olea Europaea (Olive) Fruit Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Grandis (Grapefruit) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Citrus Aurantifolia (Lime) Oil, Coriandrum Sativum (Coriander) Fruit Oil, Salvia Officinalis (Sage) Oil, Artemisia Absinthium Extract, Chamomilla Recutita (Matricaria) Flower Extract, Vanilla Planifolia Fruit Extract, Santalum Album (Sandalwood) Oil" ], "purpose": [ "PURPOSE Purpose: This vanilla-scented powder makes the skin smooth with a matte finish." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS Cautions: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rash appear. Keep out of reach of children. Replace the cap after use." ], "spl_product_data_elements": [ "BOTANICAL VANILLA SPF25 PA PLUS 01 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE TALC ALUMINUM STARCH OCTENYLSUCCINATE DIMETHICONE METHYLPARABEN MONTMORILLONITE PROPYLPARABEN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION How to Use: As the last step of make up or touch up, apply an appropriate amount to the face using a puff and gently pat the skin." ], "package_label_principal_display_panel": [ "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL Image of carton" ], "indications_and_usage": [ "INDICATIONS AND USAGE How to Use: As the last step of make up or touch up, apply an appropriate amount to the face using a puff and gently pat the skin." ], "set_id": "2624c8be-5d01-4e57-aab6-e7a13d3c9ca9", "id": "9d375f59-af8e-4dc1-9a88-4bcb88774ebb", "active_ingredient": [ "ACTIVE INGREDIENT Active Ingredients: Titanium Dioxide 6.2%, Ethylhexyl Methoxycinnamate 2%, Zinc Oxide 1.9%" ] }, { "effective_time": "20150817", "inactive_ingredient": [ "Inactive ingredients cocos nucifera (coconut) oil, olea europaea (olive) fruit oil, beeswax, euphorbia cerifera (candelilla) wax, simmondsia chinensis (jojoba) seed oil, carthamus tinctorus (safflower) seed oil, flavor, ricinus communis (castor) seed oil, helianthus annuus (sunflower) seed oil, mangifera indica (mango) seed butter, copernica cerifera (camauba) wax, jojoba esters, polyhydroxystearic acid, tocopherol [vitamin E], vanilla planifolia fruit extract, iron oxides, mica, titanium dioxide" ], "purpose": [ "Purpose Zinc oxide - Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Stop use and ask a doctor if • rash or irritation develops and lasts Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com" ], "spl_product_data_elements": [ "Softlips Pure Tint Natural Honesty Zinc oxide ZINC OXIDE ZINC OXIDE WHITE WAX" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply liberally before sun exposure and as needed • children under 6 months of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if • rash or irritation develops and lasts" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Softlips PURE natural honesty sheer lip tint/conditioner color inspired by nature 100% natural Distributed by: The Mentholatum Company Orchard Park, NY 14127 Softlips PURE natural honesty sheer lip tint/conditioner color inspired by nature 100% natural" ], "indications_and_usage": [ "Uses • helps prevent sunburn • provides UVA and UVB protection" ], "set_id": "2a3ba19e-cd1a-409c-9a97-6500f6b159c5", "id": "bcab37a6-4fdb-42b7-ba44-f337cb42c10b", "active_ingredient": [ "Active ingredient Zinc oxide 6.5%" ] }, { "effective_time": "20110118", "inactive_ingredient": [ "Inactive Ingredients Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." ], "when_using": [ "When using this product Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "SnowSkin GolfersSkin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF YELLOW WAX AVOCADO OIL YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL LANOLIN .ALPHA.-TOCOPHEROL ACETATE, DL- VANILLA" ], "description": [ "Golfers Skin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera To report a serious adverse event, contact 1-800-332-1088 Expires: Lot Number: www.golfersskin.co DIST. BY Quiver Dist, Bend Oregon, USA 97701 AS/ANZ STANDARD 2604-1998 Tested on Golfers - Not Animals Net Wt. .3oz (8.5g)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Apply generously 15 mins before sun exposure and as needed Children under 6 months of age; ask a doctor Reapply as needed or after towel drying, swimming or sweating." ], "stop_use": [ "Stop use and ask a doctor if irritation occurs or rash develops ad lasts." ], "package_label_principal_display_panel": [ "SPF 30+ very water / sweat resistant broad spectrum UVA/UVB protection Proven in extreme New Zealand conditions Golfers Skin sunscreen lip balm Net Wt. .30 oz (8.5g) contains no nanoparticles - aminobenzoic acid (PABA)-free", "Golfers Skin Lip Balm", "Golfer Skin Sunscreen" ], "indications_and_usage": [ "Uses Helps prevent sunburn Higher SPF gives more sunburn protection Provides high protection against sunburn Regains SPF after 80 minutes of sweating." ], "set_id": "2aa7a97c-1d40-4ea0-ae60-4f67eeebcce4", "id": "de7f7c3f-82ad-4e44-969d-25a2cc230bf4", "active_ingredient": [ "Active Ingredients Avobenzone 2.5% Octinoxate 7.5% Octocrylene 5.0%" ] }, { "effective_time": "20140304", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, COCAMIDOPROPYLAMINE OXIDE, DISODIUM LAURETH SULFOSUCCINATE, PPG-1-PEG-9 LAURYL GLYCOL ETHER, FRAGRANCE (PARFUM), PEG-7 GLYCERYL COCOATE, GLYCERIN, TETRASODIUM EDTA, BENZOPHENONE-4, BENZYL ALCOHOL, SODIUM CHLORIDE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, PROPYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE, VANILLA PLANIFOLIA FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CITRIC ACID, SODIUM HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)" ], "purpose": [ "PURPOSE ANTIBACTERIAL" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "questions": [ "QUESTIONS/COMMENTS? 1-866-695-3030" ], "spl_product_data_elements": [ "ORCHID BY H E B VANILLA BROWN SUGAR TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYLAMINE OXIDE DISODIUM LAURETH SULFOSUCCINATE PPG-1-PEG-9 LAURYL GLYCOL ETHER PEG-7 GLYCERYL COCOATE GLYCERIN EDETATE SODIUM SULIBENZONE BENZYL ALCOHOL SODIUM CHLORIDE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) PROPYLENE GLYCOL HYPROMELLOSES ALOE VERA LEAF VANILLA GREEN TEA LEAF CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY TO DRY HANDS, LATHER AND RINSE THOROUGHLY" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE BACTERIA ON THE SKIN" ], "set_id": "32716b5c-0855-4ff0-a29d-747aec8fe53d", "id": "5c8ffeb0-67a2-46b8-9217-483fb7a67183", "active_ingredient": [ "ACTIVE INGREDIENT TRICLOSAN 0.46% PURPOSE ANTIBACTERIAL" ] }, { "effective_time": "20120618", "inactive_ingredient": [ "Inactive Ingredients Aminomethyl propanol, Carbomer 940, FDandC Blue No. 1 (for tangerine mango scented, apple harvest scented and soothing vanilla scented), FDandC Red No. 33 (for tangerine mango scented and apple harvest scented), FDandC Yellow No. 5 (for tangerine mango scented, apple harvest scented and soothing vanilla scented), Fragrance, Glycerin, Propylene glycol, Water." ], "purpose": [ "Purpose Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out or reach of children. Children must be supervised in use of this product." ], "warnings": [ "Warnings For external use only Flammable Keep away from fire or flame. Do not apply around eyes. Do not use in ears and mouth. When using this product avoid contact with eyes. In case of contact flush eyes with water. Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours Keep out or reach of children. Children must be supervised in use of this product." ], "when_using": [ "When using this product avoid contact with eyes. In case of contact flush eyes with water." ], "spl_product_data_elements": [ "3 Hand Sanitizers ALCOHOL Soothing Vanilla Hand Sanitizer ALCOHOL ALCOHOL ALCOHOL AMINOMETHYLPROPANOL CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 D&C RED NO. 33 FD&C YELLOW NO. 5 GLYCERIN PROPYLENE GLYCOL WATER Apple Harvest Scented Hand Sanitizer ALCOHOL ALCOHOL ALCOHOL AMINOMETHYLPROPANOL CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 D&C RED NO. 33 FD&C YELLOW NO. 5 GLYCERIN PROPYLENE GLYCOL WATER Tangerine Mango Scented Hand Sanitizer ALCOHOL ALCOHOL ALCOHOL AMINOMETHYLPROPANOL CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 D&C RED NO. 33 FD&C YELLOW NO. 5 GLYCERIN PROPYLENE GLYCOL WATER" ], "description": [ "3 Hand Sanitizers Antibacterial gel - travel size 1fl oz/29ml - Total 3fl oz / 87mL 121403 1206 Made in China Imported by In US: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake VA 23320 In Canada: DTSC, Imports Burnaby, BC VSG 4P3" ], "other_safety_information": [ "Other information store at 20C-25C (68F to 77F) May discolor fabrics" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Pump as needed into your palms and thoroughly spread on both hands. rub into skin until dry." ], "stop_use": [ "Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours" ], "package_label_principal_display_panel": [ "Product Labeling Hand Sanitizer Hand Sanitizer" ], "indications_and_usage": [ "Uses Hand sanitizer to help decrease bacteria on the skin recommended for repeat use" ], "set_id": "397919c7-5fe9-4503-a936-84e2c20a52a2", "id": "6abb0e15-f193-46d9-b4a1-8edc3a28f3c9", "active_ingredient": [ "Active Ingredient Alcohol 62% Purpose Antiseptic" ] }, { "effective_time": "20150608", "inactive_ingredient": [ "INACTIVE INGREDIENT INACTIVE INGREDIENTS: Water, Cyclopentsiloxane, Methyl Trimethicone, Glycerin, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Niacinamide, Caprylyl Methicone, Pentylene Glycol, Iron Oxides (CI 77492), Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Isostearate, Phenoxyethanol, Iron Oxides (CI 77491), Trebehenin, Triethoxycaprylylsilane, Aluminum Hydroxide, Acrylates/Dimethicone Copolymer, Polyhydroxystearic Acid, Dimethicone Crosspolymer, Methyl Methacrylate Crosspolymer, Fragrance, Stearic Acid, Iron Oxides (CI 77499), Ethylhexyl Palmitate, Lecithin, Isostearic Acid, Isopropyl Myristate, Ethylhexylglycerin, Adenosine, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Lauroyl Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Trehalose, Lavandula Angustifolia (Lavender) Flower Water, Polysilicone-11, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Silica Dimethyl Silylate, Coperinicia Cerfiera (Carnauba) Wax, Hydrogenated Castor Oil Isostearate, Pistacia Lentiscus (Mastic) Gum, Ceramide 3, Caprylyl Glycol, Actinidia Polygama Fruit Extract, Portulaca Oleracea Extract, Citric Acid, Vanilla Plantifolia Fruit Extract, Sodium Benzoate, Sodium Hyaluronate, Potassium Sorbate, Hexylene Glycol, Caprylhydroxamic Acid" ], "purpose": [ "PURPOSE PURPOSE: Sunscreen" ], "warnings": [ "WARNINGS WARNINGS: If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes." ], "spl_product_data_elements": [ "Cover 10 Perfect Foundation BE20 Titanium Dioxide, Octinoxate, Zinc Oxide Titanium Dioxide TITANIUM DIOXIDE Octinoxate OCTINOXATE Zinc Oxide ZINC CATION Water Glycerin" ], "description": [ "INDICATIONS & USAGE INDICATIONS & USAGE: Shake well, pump gently, and blend effortlessly. Apply a small amount evenly over entire face. Re-apply as necessary to build desired coverage." ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton" ], "set_id": "3b896654-3ade-4ed8-bd53-57589c79e2e6", "id": "42e714be-49bc-4743-beac-2fda78194a58", "active_ingredient": [ "ACTIVE INGREDIENT ACTIVE INGREDIENTS: Titanium Dioxide (CI 77891) (13.27%), Ethylhexyl Methoxycinnamate (4.0%), Zinc Oxide (CI 77947) (0.97%)" ] }, { "effective_time": "20150116", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE (PARFUM), VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, RETINYL PALMITATE, IRON OXIDES (CI 77491), TITANIUM DIOXIDE (CI 77891), RED 33 (CI 17200)" ], "purpose": [ "PURPOSE ANTISEPTIC" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "questions": [ "QUESTIONS/COMMENTS? 1-866-695-3030" ], "spl_product_data_elements": [ "ORCHID ANTIBACTERIAL VANILLA AND APPLE BLOSSOM ETHYL ALCOHOL ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL GLYCERIN ISOPROPYL MYRISTATE AMINOMETHYLPROPANOL CARBOMER 934 .ALPHA.-TOCOPHEROL ACETATE VANILLA APPLE ALOE VERA LEAF MANNITOL POWDERED CELLULOSE HYPROMELLOSES VITAMIN A PALMITATE FERRIC OXIDE RED TITANIUM DIOXIDE D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "storage_and_handling": [ "OTHER INFORMATION STORE AT A TEMPERATURE BELOW 110°F (43°C)" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE BACTERIA ON THE SKIN" ], "set_id": "3c48b399-2860-4b6c-937f-ac719e7f9b10", "id": "3d6b189d-d808-4812-8e98-f007760710e4", "active_ingredient": [ "ACTIVE INGREDIENT ETHYL ALCOHOL 62% PURPOSE ANTISEPTIC" ] }, { "effective_time": "20110316", "inactive_ingredient": [ "Inactive ingredients Cherry Flavor, Citric Acid, Glycerin, Menthol Crystals, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Vanilla Flavor. Other information Store at 68° - 77° F (20° - 25° C) Questions? Comments? Call 1-866-934-6025 Manufactured for: Kylemore Pharmaceuticals, LLC Port St. Joe, FL 32456 323-10 Rev. 12/09 cv" ], "warnings": [ "Warnings Do not exceed recommended dosage. Do not use this product · do not take this product if you have chronic pulmonary disease, shortness of breath,or children who are taking other drugs, unless directed by a doctor. Ask a doctor before use if you have · a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema · a cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if · cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. · new symptoms occur · may cause or aggravate constipation If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of accidental overdose, seek professional assistance, or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Codeine Phosphate Guaifenesin Codeine Phosphate, Guaifenesin CODEINE PHOSPHATE CODEINE GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE GLYCERIN MENTHOL PROPYLENE GLYCOL WATER SODIUM CITRATE SACCHARIN SODIUM SORBITOL cherry-vanilla" ], "description": [ "Drug Facts Active ingredients (in each 5 mL teaspoonful) Codeine Phosphate* 10 mg ........ Antitussive *WARNING: May be habit forming Guaifenesin 200 mg ................. Expectorant" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions Take this medication with a full glass of water after each dose to help loosen mucus in the lungs. chart" ], "package_label_principal_display_panel": [ "PACKAGING: Codeine Phosphate 10 mg Guaifenesin 200 mg labeling: label" ], "indications_and_usage": [ "Uses · temporarily relieves these symptoms due to the common cold: · cough due to minor throat and bronchial irritation · helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive" ], "set_id": "3e54a1cb-73ce-435c-8528-899462f157fd", "id": "194b5e70-f37c-41c3-b230-b62984dcb79d" }, { "effective_time": "20141001", "inactive_ingredient": [ "Ingredients *Helianthus Annuus ( Sunflower ) Oil, *Cera Alba ( Beeswax ), Essential Oils of *Citrus Aurantium Dulcis ( Sweet Orange ) and* Citrus Tangerina ( Tangerine ), and CO 2 Extracts of *Hippophae Rhamnoides ( Seabuckthorn ) and *Vanilla Planifolia ( Vanilla ), Tocopherol ( Sunflower Vitamin E ). *=Certified Organic" ], "instructions_for_use": [ "Directions: • For full protection, apply liberally (2 mg/cm 2 of skin) to exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect. Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours Sun Protection Measures: • Spending time in the sun increases your risk of skin cancer and early skin aging • To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10am - 2pm • Wear long-sleeved shirts, pants, hats, and sunglasses • For children under 6 months of age: ask a doctor." ], "purpose": [ "Purpose: Sunscreen" ], "warnings": [ "Warnings: For external use only Do not use on damaged or broken skin. Stop and ask a doctor is rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "Do not use on damaged or broken skin. Stop and ask a doctor is rash occurs. When using this product keep out of eyes. Rinse with water to remove.", "When using this product keep out of eyes. Rinse with water to remove.", "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Badger SPF 30 Kids Sunscreen Zinc Oxide Zinc Oxide ZINC OXIDE SUNFLOWER OIL YELLOW WAX ORANGE OIL MANDARIN OIL HIPPOPHAE RHAMNOIDES FRUIT VANILLA TOCOPHEROL" ], "warnings_and_cautions": [ "Active Ingredient Non-Nano Uncoated Zinc Oxide 18.75%" ], "other_safety_information": [ "Other Information: Store at temperatures below 90°F." ], "openfda": {}, "version": "2", "package_label_principal_display_panel": [ "Principal Display Panel Image Components image description" ], "indications_and_usage": [ "Uses: • Helps prevent sunburn • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "42f87574-5527-46e1-a670-0158a76e0b9f", "id": "98e927c5-9ea3-46bc-92c6-c165c9033cf4" }, { "effective_time": "20101230", "inactive_ingredient": [ "Inactive ingredients Citric Acid, Glycerin, Orange Vanilla Flavor, propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol." ], "purpose": [ "Cough Suppressant Expectorant Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately." ], "questions": [ "Questions? Comments? Call 1-787-832-6645 Serious side effects associated with this product may be reported to this number." ], "spl_product_data_elements": [ "Clophed Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride Chlophedianol Hydrochloride Chlophedianol Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine Citric Acid Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol" ], "ask_doctor": [ "Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period Children 6 to under 12 years of age: 1 teaspoonful every 6 to 8 hours, not to exceed 4 teaspoonfuls in a 24 hour period Children under 6 years of age Consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur" ], "storage_and_handling": [ "Other information Store at 59° - 86° F(15° - 30° C)" ], "do_not_use": [ "Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product" ], "package_label_principal_display_panel": [ "Product Packaging: Packaging below represents the labeling currently used: Principal display panel and side panel for 118 mL label: NDC 49963-630-04 Clophed Each teaspoonful (5 mL) for oral administration contains: Chlophedianol HCl.....................................12.5 mg Guaifenesin...............................................100 mg Phenylephrine HCl.........................................5 mg Cough Suppressant/Expectorant/Nasal Decongestant Alcohol Free/Dye Free/Gluten Free/Sugar Free 4 fl oz (118 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Supplied in a tight, light-resistant container with a child-resistant cap. See package insert for full prescribing information. Manufactured for: Portal Pharmaceutical Mayaguez, PR 00680 Rev. 10/09 Clophed Packaging Clophed Packaging Clophed Packaging" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation helps loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive nasal congestion reduces swelling of the nasal passages" ], "set_id": "49370e61-f9db-47d0-a43f-b1797b077867", "id": "11108f5d-d9ea-498e-ba87-a6eff07dfa7f", "active_ingredient": [ "Drug Facts Active ingredients ( in each 5 mL teaspoonful) Chlophedianol Hydrochloride 12.5 mg Guaifenesin 100 mg Phenylephrine Hydrochloride 5 mg Cough Suppressant Expectorant Nasal Decongestant" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and over: 2 teaspoonfuls every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age: 1 teaspoonful every 6 to 8 hours, not to exceed 4 teaspoonfuls in a 24 hour period
Children under 6 years of age Consult a doctor
" ] }, { "effective_time": "20110622", "inactive_ingredient": [ "WATER, SODIUM LAURETH SULFATE, SODIUM COCOYL SARCOSINATE, COCAMIDOPROPYL BETAINE, FRAGRANCE, VANILLA PLANIFOLIA FRUIT EXTRACT, SODIUM PCA, BETAINE, SORBITOL, GLYCINE, ALANINE, PROLINE, SERINE, THREONINE, ARGININE, LYSINE, GLUTAMIC ACID, ALOE BARBADENSIS LEAF JUICE, PEG-120 METHYL GLUCOSE DIOLEATE, PEG-7 GLYCERYL COCOATE, TETRASODIUM EDTA, CITRIC ACID, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE." ], "purpose": [ "PURPOSE ANTIBACTERIAL" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS. KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER." ], "spl_product_data_elements": [ "ANTIBACTERIAL TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE VANILLA SODIUM PYRROLIDONE CARBOXYLATE BETAINE SORBITOL GLYCINE ALANINE PROLINE SERINE THREONINE ARGININE LYSINE GLUTAMIC ACID ALOE VERA LEAF PEG-120 METHYL GLUCOSE DIOLEATE PEG-7 GLYCERYL COCOATE EDETATE SODIUM CITRIC ACID MONOHYDRATE SODIUM CHLORIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS PUMP ONTO WET HANDS, WORK INTO A LATHER, RINSE THROUGHLY." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS." ], "package_label_principal_display_panel": [ "IMAGE OF ANTIBACTERIAL" ], "indications_and_usage": [ "USES FOR WASHING TO DECREASE BACTERIA ON THE SKIN." ], "set_id": "4b71f1d5-39f6-46f8-adf5-ff2db65bc77a", "id": "cdc6cd57-b88d-43d4-a1b2-640c109e694b", "active_ingredient": [ "ACTIVE INGREDIENT TRICLOSAN 0.15%" ] }, { "effective_time": "20131205", "inactive_ingredient": [ "Inactive ingredients water・glycerin ・butylene glycol・dimethicone・dicaprylyl carbonate・polyacrylamide・portulaca oleracea extract・polysorbate 60・citrus aurantium bergamia (bergamot) fruit oil・olea europaea (olive) fruit oil・citrus aurantium dulcis (orange) oil・citrus grandis (grapefruit) peel oil・lavandula angustifolia (lavender) oil・cedrus atlantica bark oil・pelargonium graveolens flower oil・copaifera officinalis (balsam copaiba) resin・jasminum officinale (jasmine) oil・myrtus communis oil・Artemisia absinthium extract・ rose flower oil・vanilla planifolia fruit extract・ferula galbaniflua galbanum) resin・glyceryl stearate・ cyclopentasiloxane・peg-100 stearate・c13-14 isoparaffin・behenyl alcohol・dimethiconw/vinyl dimethiconecrosspolymer・caprylyl glycol・carbomer・triethanolamine・hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer・xanthan gum・laureth-7・caprylhydroxamic acid・fragrance ・phenoxyethanol・Royal Jelly" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask doctor. If rash occurs." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove" ], "questions": [ "Questions? Call 1-877-727-5530" ], "spl_product_data_elements": [ "Renove ROYAL PERFECT HAND Broad Spectrum SPF 15 ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, AVOBENZONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE WATER GLYCERIN BUTYLENE GLYCOL DIMETHICONE DICAPRYLYL CARBONATE POLYSORBATE 60 BERGAMOT OIL OLIVE OIL ORANGE OIL CITRUS MAXIMA FRUIT RIND OIL LAVENDER OIL CEDRUS ATLANTICA BARK OIL PELARGONIUM GRAVEOLENS FLOWER OIL COPAIFERA OFFICINALIS RESIN JASMINUM OFFICINALE FLOWER MYRTLE LEAF OIL WORMWOOD ROSA RUGOSA FLOWER BUD VANILLA GALBANUM OIL GLYCERYL MONOSTEARATE CYCLOMETHICONE 5 PEG-100 STEARATE C13-14 ISOPARAFFIN DOCOSANOL CAPRYLYL GLYCOL TROLAMINE XANTHAN GUM LAURETH-7 CAPRYLHYDROXAMIC ACID PHENOXYETHANOL ROYAL JELLY" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions For sunscreen use: Apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses Children under 6 months of age: Ask a doctor" ], "spl_unclassified_section": [ "Renove ROYAL PERFECT HAND CREAM Broad Spectrum SPF 15", "Other information protect this product from excessive heat and direct sun" ], "stop_use": [ "Stop use and ask doctor. If rash occurs." ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "Renove ROYAL PERFECT HAND CREAM Broad Spectrum SPF 15 75g (60782-001-00) Renove Hand Cream" ], "indications_and_usage": [ "Uses helps prevent sunburn" ], "set_id": "4fe7060d-60c3-4151-aed8-e7aef2acb319", "id": "9da7f217-7080-4886-a74f-4ad45d0a7c36", "active_ingredient": [ "Active ingredients Ethylhexyl methoxycinnamate 6.8% Ethylhexyl salicylate 4.2% Avobenzone 1% Purpose Sunscreen" ] }, { "effective_time": "20111201", "inactive_ingredient": [ "Inactive Ingredients Warm Vanilla Sugar Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5 Sweet Cherry Blossom Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Fresh Ocean Breeze Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5 Cool Cucumber Melon Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Irresistible Green Apple Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Yellow 5 Alluring Red Pomegranate Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 40, Red 33, Blue 1 Sparkling White Cranberry Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Crisp White Citrus Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Sheer Cotton Whisper Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Red 33, Yellow 5 Rich Shea & Cocoa Butter Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Red 33, Yellow 5 Dark Amethyst Rush Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1 Merry Berry Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5, Blue 1 Peppermint Twist Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Yellow 5, Red 33 Spring Fling Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate Kiss and Tell Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate Coconut Lime Verbena Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Tropical Passion Fruit Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1", "Questions? 1-800-FDA-1088 Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For Shopko Stores Operating Co., LLC Green Bay, WI 54307, U.S.A. ©2010 Shopko Stores Operating Co., LLC" ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation and redness develop. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE FD&C RED NO. 40 D&C RED NO. 33 FD&C BLUE NO. 1 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 VITAMIN A PALMITATE Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- D&C RED NO. 33 FD&C BLUE NO. 1 VITAMIN A PALMITATE Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Cleanser triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions wet hands, work into rich lather rinse well" ], "spl_unclassified_section": [ "SATISFACTION GUARANTEED BY REFUND OR EXCHANGE" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Warm VANILLA SUGAR antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Warm Vanilla Sugar Bottle Label Warm Vanilla Sugar Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Sweet CHERRY BLOSSOM antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Sweet Cherry Blossom Bottle Label Sweet Cherry Blossom Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Fresh OCEAN BREEZE antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Fresh Ocean Breeze Bottle Label Fresh Ocean Breeze Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Cool CUCUMBER MELON antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Cool Cucumber Melon Bottle Label Cool Cucumber Melon Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Irresistible GREEN APPLE antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Irresistible Green Apple Bottle Label Irresistible Green Apple Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Alluring RED POMEGRANATE antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Alluring Red Pomegranate Bottle Label Alluring Red Pomegranate Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Sparkling WHITE CRANBERRY antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Sparkling White Cranberry Bottle Label Sparkling White Cranberry Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Crisp WHITE CITRUS antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Crisp White Citrus Bottle Label Crisp White Citrus Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Sheer COTTON WHISPER antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Sheer Cotton Whisper Bottle Label Sheer Cotton Whisper Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® LIMITED EDITION Rich SHEA & COCOA BUTTER antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Rich Shea & Cocoa Butter Bottle Label Rich Shea & Cocoa Butter Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® LIMITED EDITION Dark AMETHYST RUSH antibacterial foaming hand soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Dark Amethyst Rush Bottle Label Dark Amethyst Rush Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Merry Berry Antibacterial Foaming Hand Soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Merry Berry Bottle Label Merry Berry Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Peppermint Twist Antibacterial Foaming Hand Soap PARABEN FREE contains aloe vera and vitamins A & E 9.8 fl oz Peppermint Twist Bottle Label Peppermint Twist Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Spring Fling antibacterial foaming hand soap paraben free contains minerals and vitamins A & E 9.8 fl oz Spring Fling Bottle Label Spring Fling Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Kiss and Tell antibacterial foaming hand soap paraben free contains minerals and vitamins A & E 9.8 fl oz Kiss and Tell Bottle Label Kiss and Tell Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® LIMITED EDITION Coconut Lime Verbena antibacterial foaming hand soap paraben free contains minerals and vitamins A & E 9.8 fl oz Coconut Lime Verbena Bottle Label Coconut Lime Verbena Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® LIMITED EDITION Tropical Passion Fruit antibacterial foaming hand soap paraben free contains minerals and vitamins A & E 9.8 fl oz Tropical Passion Fruit Bottle Label Tropical Passion Fruit Bottle Label" ], "indications_and_usage": [ "Uses handwashing to decrease bacteria on skin" ], "set_id": "531c61fd-5b1a-4144-badc-cfa18f2eb59e", "id": "b29fe357-90f9-418a-a8c9-1ea76f29c296", "active_ingredient": [ "Active ingredient Triclosan 0.3%" ] }, { "effective_time": "20120822", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients: Talc, Methicone, Aluminum Starch Octenylsuccinate, Dimethicone, Methylparaben, Montmorillonite, Propylparaben, Fragrance, Iron Oxides, Mica, Olea Europaea (Olive) Fruit Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Grandis (Grapefruit) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Citrus Aurantifolia (Lime) Oil, Coriandrum Sativum (Coriander) Fruit Oil, Salvia Officinalis (Sage) Oil, Artemisia Absinthium Extract, Chamomilla Recutita (Matricaria) Flower Extract, Vanilla Planifolia Fruit Extract, Santalum Album (Sandalwood) Oil, Red 30" ], "purpose": [ "PURPOSE Purpose: This vanilla-scented pact makes the skin moist with a matte finish." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS Cautions: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rash appear. Keep out of reach of children. Replace the cap after use." ], "spl_product_data_elements": [ "BOTANICAL VANILLA SPF25 PA PLUS 02 VANILLA PINK TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE TALC ALUMINUM STARCH OCTENYLSUCCINATE DIMETHICONE METHYLPARABEN MONTMORILLONITE PROPYLPARABEN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION How to Use: At the last step of make up or touch up, apply an appropriate amount to the face using a puff and gently pat the skin." ], "package_label_principal_display_panel": [ "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL Image of carton" ], "indications_and_usage": [ "INDICATIONS AND USAGE How to Use: At the last step of make up or touch up, apply an appropriate amount to the face using a puff and gently pat the skin." ], "set_id": "5332bf2d-4d18-4acc-b1d1-0fad0e81ae6f", "id": "551d984d-9f85-4438-82d0-8e5878e04254", "active_ingredient": [ "ACTIVE INGREDIENT Active Ingredients: TITANIUM DIOXIDE 6.1%, ETHYLHEXYL METHOXYCINNAMATE 2%, ZINC OXIDE 1.9%" ] }, { "effective_time": "20140220", "inactive_ingredient": [ "Inactive Ingredients Neem Leaf Extract (aqueous), Shea Butter (Butyrospermum parkii), Emulsifying Wax, Cetearyl Alcohol and Behentrimonium Chloride, Vanilla Extract, Spearmint Essential Oil" ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use if significant irritation or sensitization occurs." ], "warnings": [ "Warnings For external use only Flammable, keep away from fire or flame. When using this product avoid contact with eyes. In case of eye contact, flush with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use if significant irritation or sensitization occurs." ], "when_using": [ "When using this product avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions: call 1-800-664-8009" ], "spl_product_data_elements": [ "Every Day Shea Moisturizing Shea Butter Hand Sanitizer Vanilla Mint ALCOHOL ALCOHOL ALCOHOL AZADIRACHTA INDICA LEAF SHEA BUTTER CETOSTEARYL ALCOHOL BEHENTRIMONIUM CHLORIDE VANILLA SPEARMINT OIL" ], "other_safety_information": [ "Flammable, keep away from fire or flame." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Apply one pump of moisturizing sanitizer to dry hands.Rub into skin. No rinsing required. Supervise children in the use of this product." ], "spl_unclassified_section": [ "Every Day Shea Moisturizing Shea Butter Hand Sanitizer Vanilla Mint Drug Facts", "Handmade in the USA by Allafia www.EveryDayShea.com Olympia, WA 98501" ], "package_label_principal_display_panel": [ "Every Day Shea Moisturizing Shea Butter Hand Sanitizer Vanilla Mint 12oz (51441-002-12) DrugFactsVanillaMint FrontPanelVanillaMint" ], "indications_and_usage": [ "Uses For hand sanitizing to reduce bacteria on skin Recommended for repeated use." ], "set_id": "55888daf-0321-4ae7-be5e-e09e22997d4a", "id": "aaf61f08-33e8-457e-81ed-b03cfcdeef66", "active_ingredient": [ "Active Ingredient Ethyl Alcohol 62%" ] }, { "effective_time": "20150817", "inactive_ingredient": [ "Inactive ingredients cocos nucifera (coconut) oil, olea europaea (olive) fruit oil, beeswax, euphorbia cerifera (candelilla) wax, simmondsia chinensis (jojoba) seed oil, carthamus tinctorius (safflower) seed oil, flavor, helianthus annuus (sunflower) seed oil, mangifera indica (mango) seed butter, ricinus communis (castor) seed oil, copernica cerifera (camauba) wax, jojoba esters, polyhydroxystearic acid, tocopherol [vitamin E], vanilla planifolia fruit extract, carmine, mica, titanium dioxide" ], "purpose": [ "Purpose Zinc oxide - Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Stop use and ask a doctor if • rash or irritation develops and lasts Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com" ], "spl_product_data_elements": [ "Softlips Pure Tint Shell Pink Zinc oxide ZINC OXIDE ZINC OXIDE WHITE WAX" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply liberally before sun exposure and as needed • children under 6 months of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if • rash or irritation develops and lasts" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Softlips PURE shell pink sheer lip tint/conditioner color inspired by nature 100% natural Distributed by: The Mentholatum Company Orchard Park, NY 14127 Softlips PURE shell pink sheer lip tint/conditioner color inspired by nature 100% natural" ], "indications_and_usage": [ "Uses • helps prevent sunburn • provides UVA and UVB protection" ], "set_id": "59204504-a12a-49f5-a9c0-1d994f1bc9a1", "id": "e5c525f8-86e4-4272-b8b7-e42e53b441dc", "active_ingredient": [ "Active ingredient Zinc oxide 6.5%" ] }, { "effective_time": "20110117", "inactive_ingredient": [ "Inactive Ingredients Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." ], "when_using": [ "When using this product Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Snow Skin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL LANOLIN .ALPHA.-TOCOPHEROL ACETATE, DL- VANILLA" ], "description": [ "Snowskin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera To report a serious adverse event, contact 1-800-332-1088 Expires: Lot Number: www.surfersskin.co DIST. BY Quiver Dist, Bend Oregon, USA 97701 AS/ANZ STANDARD 2604-1998 Tested on Snowboarders - Not Animals Net Wt. .3oz (8.5g)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply generously 15 mins before sun exposure and as needed Children under 6 months of age; ask a doctor Reapply as needed or after towel drying, swimming or sweating." ], "stop_use": [ "Stop use and ask a doctor if irritation occurs or rash develops ad lasts." ], "package_label_principal_display_panel": [ "SPF 30+ very water / sweat resistant broad spectrum UVA/UVB protection Proven in extreme New Zealand conditions Snow Skin sunscreen lip balm Net Wt. .30 oz (8.5g) contains no nanoparticles - aminobenzoic acid (PABA)-free", "Snowskin Skin Lip Balm", "Snow Skin Sunscreen Lip Balm" ], "indications_and_usage": [ "Uses Helps prevent sunburn Higher SPF gives more sunburn protection Provides high protection against sunburn Regains SPF after 80 minutes of sweating." ], "set_id": "631c77b0-9e09-4250-b81b-1cdce161cb29", "id": "4921d750-f94a-4603-9f5d-15c32b0fe3ef", "active_ingredient": [ "Active Ingredients Avobenzone 2.5% Octinoxate 7.5% Octocrylene 5.0%" ] }, { "effective_time": "20140725", "inactive_ingredient": [ "Inactive Ingredients USP White Petrolatum, Lemon Concentrate, Glycerin, Honey, Prunus Amygdalus Dulcis (Almond Oil), Alpha tocopherol (Vitamin E), Beeswax, Soy Wax, Talc, Boric acid, Zinc oxide, Stearic acid, Pistachia lenticus (Mastica), Vanilla" ], "purpose": [ "Purpose Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away" ], "warnings": [ "WARNINGS For external use only" ], "when_using": [ "When using this product Do not get into eyes" ], "questions": [ "Questions or Comments 1-844-Buy-ELAJ (949-581-1200) or visit www.elajnaturally.com" ], "spl_product_data_elements": [ "Skin Protectant Colloidal Oatmeal OATMEAL OATMEAL PETROLATUM GLYCERIN HONEY ALMOND OIL .ALPHA.-TOCOPHEROL YELLOW WAX Talc BORIC ACID ZINC OXIDE STEARIC ACID Vanilla" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply as needed or recommended 3-4 x a day initially during flare up and as needed after flareup begins to subside Apply generously before bed to help avoid itching while sleeping" ], "stop_use": [ "Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear and occur again within a few days." ], "storage_and_handling": [ "Storage Store at room temperature" ], "package_label_principal_display_panel": [ "Product Packaging Labels 57 g, 113 g, and 227 g Box Labels 57 g, 113 g, and 227 g Container Labels 57 g, 113 g, and 227 g Box Labels 57 g, 113 g, and 227 g Container Labels" ], "indications_and_usage": [ "Uses Temporarily protects and helps relieve minor skin irritations and itching due to eczema" ], "set_id": "6537167b-4f8a-485e-bf20-b23d55d5437c", "id": "7d1c93bb-808e-4e8d-9670-af940f07a4bc", "active_ingredient": [ "Active Ingredient Colloidal Oatmeal 1.0%" ] }, { "effective_time": "20100803", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Aqua (Water), Dimethicone, Olea Europaea (Olive) Fruit Oil, Glycerin, Cyclopentasiloxane, Seareth-20, Stearyl Alcohol, Tetrahexyldecyl Ascorbate, PPG-3 Benzyl Ether Myristate, Neopentyl Glycol Diheptanoate, C12-15 Alkyl Benzoate, Cetyl Palmitate, Butyropsermum Parkii (Shea Butter), Citrus Paradisi (Grape Fruit) Oil, Prunus Armeniaca (Apricot) Kernel oil, Sorbitan Palmitate, Sorbitan Olivate, Cyclohexasiloxane, Dimethyl MEA (DMAE), Squalane, Xanthan Gum, Phenoxyethanol, Carthamus Tinctorius (Safflower) Seed Oil, Perfume (Fragrance), Caprylyl Glycol, Tocopheryl Acetate, Limonene, Triethoxycaprylylsilane, Galactoarabina, Propylne Glycol, Olea Europaea (Olive) Leaf Extract, Ethylhexylglycerin, Hexylene Glycol, Thioctic Acid (Alpha-Lipoic Acid), Ubiquinone, Disodium EDTA, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Extract, Magnesium Aspartate, Zinc Gluconate, Hydrolyzed Glycosaminoglycans, Elaeis Guineensis (Palm)oil, Tocotrienols, Camellia Sinensis (Green Tea) Leaf Extract, Titanium Dioxide, Vanilla Planifolia Fruit Extract, Vanillin, Tocopherol, Copper Gluconate, Sodium Hyaluronate, Linalool, Aluminum Hydroxide, Stearic Acid." ], "purpose": [ "PURPOSE: Sunscreen" ], "warnings": [ "WARNINGS: For external use only. WHEN USING THIS PRODUCT: Keep out of eyes. Rinse with water to remove. STOP USE AND ASK A DOCTOR IF Rash or irritation develops and lasts. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "More Than Moisture SPF 30 Zinc Oxide ZINC OXIDE ZINC OXIDE" ], "ask_doctor": [ "DIRECTIONS: Dr. Perricone recommends applying liberally on cleaned skin or on top of treatment every 2 hours before sun exposure and as needed. For children under 6 years old, consult a doctor before use." ], "openfda": {}, "version": "1", "storage_and_handling": [ "OTHER INFORMATION: Store at room temperature. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun." ], "package_label_principal_display_panel": [ "DISTRIBUTED BY: US: NV Perricone LLC, Meriden CT 06450 USA UK: NV Perricone MD Cosmeceuticals LTD, London, W1S 2YE UK IMAGE OF THE PRINCIPAL DISPLAY PANEL: Image of Product: Perricone MD More Than Moisture SPF 30" ], "indications_and_usage": [ "USES: Helps prevent sunburn. Higher SPF gives more sunburn protection." ], "set_id": "691a1203-9293-45d3-9b64-a435caf0c971", "id": "d602176d-bde5-462c-bb52-714baf35a214", "active_ingredient": [ "ACTIVE INGREDIENT: Zinc Oxide 10.5%" ] }, { "effective_time": "20101124", "inactive_ingredient": [ "Inactive Ingredients Warm Vanilla Sugar Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5 Sweet Cherry Blossom Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Fresh Ocean Breeze Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5 Cool Cucumber Melon Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Irresistible Green Apple Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Yellow 5 Alluring Red Pomegranate Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 40, Red 33, Blue 1 Sparkling White Cranberry Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Crisp White Citrus Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Sheer Cotton Whisper Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Red 33, Yellow 5", "Questions? 1-800-FDA-1088" ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. If contact occurs, rinse thoroughly with water. Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor." ], "warnings": [ "Warnings For external use only. Flammable, keep away from fire or flame. Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. If contact occurs, rinse thoroughly with water. Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor." ], "spl_product_data_elements": [ "Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE FD&C RED NO. 40 D&C RED NO. 33 FD&C BLUE NO. 1 Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Foaming Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALCOHOL ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions apply to hands until thoroughly wet rub vigorously until dry supervise children in the use of this product" ], "spl_unclassified_section": [ "SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For Shopko Stores Operating Co., LLC Green Bay, WI 54307, U.S.A. ©2010 Shopko Stores Operating Co., LLC" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Warm VANILLA SUGAR antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Warm Vanilla Sugar Bottle Label Warm Vanilla Sugar Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Sweet CHERRY BLOSSOM antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Sweet Cherry Blossom Bottle Label Sweet Cherry Blossom Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Fresh OCEAN BREEZE antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Fresh Ocean Breeze Bottle Label Fresh Ocean Breeze Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Cool CUCUMBER MELON antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Cool Cucumber Melon Bottle Label Cool Cucumber Melon Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Irresistible GREEN APPLE antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Irresistible Green Apple Bottle Label Irresistible Green Apple Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Alluring RED POMEGRANATE antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Alluring Red Pomegranate Bottle Label Alluring Red Pomegranate Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Sparkling WHITE CRANBERRY antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Sparkling White Cranberry Bottle Label Sparkling White Cranberry Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Crisp WHITE CITRUS antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Crisp White Citrus Bottle Label Crisp White Citrus Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Sheer COTTON WHISPER antibacterial foaming hand sanitizer PARABEN FREE contains aloe vera and vitamins A & E 1.7 fl oz Sheer Cotton Whisper Bottle Label Sheer Cotton Whisper Bottle Label" ], "indications_and_usage": [ "Uses to decrease bacteria on the skin and clean hands recommended for repeated use" ], "set_id": "69daf06e-5f03-445c-9155-f07760d566d0", "id": "2220b62f-fed4-4304-9747-805f485be4ce", "active_ingredient": [ "Active ingredient Benzalkonium chloride 0.11%" ] }, { "effective_time": "20111226", "inactive_ingredient": [ "Inactive ingredient Corn Starch, Croscarmellose Sodium, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor. R02/11 Manufactured by: Contract Pharmacal Corp. 135 Adams Avenue Hauppauge, NY 11788 USA www.cpc.com" ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use In children under 12 years of age unless directed by a doctor" ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "spl_product_data_elements": [ "Meclizine Meclizine HCl MECLIZINE HYDROCHLORIDE MECLIZINE CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C RED NO. 40 LACTOSE MONOHYDRATE MAGNESIUM STEARATE RASPBERRY SILICON DIOXIDE SACCHARIN SODIUM STEARIC ACID VANILLA 258" ], "ask_doctor": [ "Ask a doctor before use if you have breathing problems such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlarged prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions To prevent motion sickness, the first dose should be taken one hour before starting activity. Adults and children 12 years of age and over: chew 1 to 2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Not for frequent or prolonged use except on the advice of a doctor. DO NOT EXCEED RECOMMENDED DOSE Other information Store at room temperature, USP" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "spl_unclassified_section": [ "DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Drug Facts" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 11a2b58b-figure-01" ], "indications_and_usage": [ "Uses for the prevention and treatment of the nausea, vomiting, dizziness associated with motion sickness" ], "set_id": "6e297ed1-3734-4af3-b5ec-8fdc37dba808", "id": "11a2b58b-304c-4d79-920e-508701c3c19f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each tablet) Meclizine HCl 25 mgi" ] }, { "effective_time": "20150608", "inactive_ingredient": [ "INACTIVE INGREDIENT INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Methyl Trimethicone, Glycerin, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Niacinamide, Caprylyl Methicone, Pentylene Glycol, Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Isosteareate, Phenoxyethanol, Tribehenin, Iron Oxides (CI 77491), Aluminum Hydroxide, Triethoxycaprylylsilane, Acrylates/Dimethicone Copolymer, Polyhydroxystearic Acid, Dimethicone Crosspolymer, Fragrance, Stearic Acid, Iron Oxides (CI 77499), Ethylhexyl Palmitate, Lecithin, Isostearic Acid, Isopropyl Myristate, Ethylhexylglcerin, Adenosine, Polyglceryl-3 Polyricinoleate, Disodium EDTA, Lauroyl Lysine, Vinyl ?Dimethicone / Methicone Silsesquioxane Crosspolymer, Trehalose, Lavandula Angustifolia (Lavender) Flower Water, Polysilicone-11, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Silica Dimethyl Cerifera (Carnauba) Wax, Hydrogenated Castor Oil Isostearate, Pistacia Lentiscus (Mastic) Gum, Ceramide, Caprylyl Glycol, Actinidia Polygama Fruit Extract, Portulaca Oleracea Extract, Citric Acid, Vanilla Planifolia Fruit Extract, Sodium Benzoate, Potassium Sorbate, Hexylene Glycol, Caprylhydroxamic Acid" ], "purpose": [ "PURPOSE PURPOSE: Sunscreen" ], "warnings": [ "WARNINGS WARNINGS: If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes." ], "spl_product_data_elements": [ "Cover 10 Perfect Foundation BP15 Titanium Dioxide, Octinoxate, Zinc Oxide Titanium Dioxide TITANIUM DIOXIDE Octinoxate OCTINOXATE Zinc Oxide ZINC CATION Water Glycerin" ], "description": [ "INDICATIONS & USAGE INDICATIONS & USAGE: Shake well, pump gently, and blend effortlessly. Apply a small amount evenly over entire face. Re-apply as necessary to build desired coverage." ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton" ], "set_id": "6ecfae21-bb77-4075-8530-08f35062899e", "id": "65aebd34-a2c9-46c6-931d-5418c6dfaca9", "active_ingredient": [ "ACTIVE INGREDIENT ACTIVE INGREDIENTS: Titanium Dioxide (CI 77891) (13.27%), Ethylhexyl Methoxycinnamate (4.0%), Zinc Oxide (CI 77947) (0.97%)" ] }, { "effective_time": "20110401", "inactive_ingredient": [ "Inactive ingredients croscarmelose sodium, ethylcellulose, FD&C red #40 lake, ethylene glycol & vinyl alcohol graft copolymer, malic acid, methacrylic copolymer, monoammonium glycyrrhizinate, non fat dry milk, octaglycerol monooleate emulsifier, vegetable oil, polysorbate 80, salt, silicon dioxide, sodium starch glycolate, soy lecithin, strawberry flavors, sucralose, sugar, vanilla flavor" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "To report serious side effects associated with the use of this product call 1-800-505-COLD (2653)" ], "spl_product_data_elements": [ "Kids-EEZE Chest Relief Guaifenesin Guaifenesin Guaifenesin CROSCARMELLOSE SODIUM ETHYLCELLULOSE (4 MPA.S) ETHYLENE GLYCOL MALIC ACID LECITHIN, SOYBEAN METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) SUCRALOSE SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Chew and swallow as directed below Do not take more than 6 doses in 24 hours adults and children 12 years and over 2 to 4 chews every 4 hours children 6 years to under 12 years 1 to 2 chews every 4 hours children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each soft chew contains 17 mg sodium tamper evident: do not use if inner blister pack is torn or open store at controlled room temperature 20-25°C (68-77°F)" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 100 mg Tablet Carton NDC 61941-1002-6 Kids-EEZE ® From The Makers Of Cold-EEZE ® Chest Relief EXPECTORANT • GUAIFENESIN 100 mg + Relieves Chest Congestion + Thins & Loosens Mucus Soft Chew Great Tasting Strawberry ARTIFICIALLY FLAVORED 12 SOFT CHEWS TAMPER EVIDENT: Do Not Use If Inner Seal Is Torn Or Open PRINCIPAL DISPLAY PANEL - 100 mg Tablet Carton" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive." ], "set_id": "6f2276fb-7a69-4aae-87f4-8c78e71bfa7b", "id": "4f391211-f806-4c0f-887b-d32759754a49", "active_ingredient": [ "Active ingredient (in each soft chew) Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 to 4 chews every 4 hours
children 6 years to under 12 years 1 to 2 chews every 4 hours
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20120511", "inactive_ingredient": [ "Inactive ingredients (Vanilla Scream) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5", "Inactive ingredients (Scary Cat Cherry) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5", "Inactive ingredients (Berry Bite) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5", "Inactive ingredients (Poison Apple) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5" ], "purpose": [ "Purpose Anti-bacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Flammable, keep away from fire or flame. Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. If contact occurs, rinse thoroughly with water. Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor." ], "questions": [ "QUESTIONS? 1-800-FDA-1088" ], "spl_product_data_elements": [ "Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C RED NO. 40 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply to hands until thoroughly wet. Rub vigorously until dry. Supervise children in the use of this product." ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Vanilla Scream anti-bacterial hand gel 1 fl. oz. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Scary Cat Cherry anti-bacterial hand gel 1 fl. oz. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Berry Bite anti-bacterial hand gel 1 fl. oz. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Poison Apple anti-bacterial hand gel 1 fl. oz. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Bottle Label Bottle Label" ], "indications_and_usage": [ "Use To decrease bacteria on the skin and clean hands. Recommended for repeated use." ], "set_id": "71f0dead-1b4e-4ce4-8f15-9969c129cec1", "id": "71f0dead-1b4e-4ce4-8f15-9969c129cec1", "active_ingredient": [ "Active Ingredient Ethyl Alcohol 62% w/w" ] }, { "effective_time": "20111206", "inactive_ingredient": [ "Inactive Ingredients Sweet Cherry Blossom Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5 Warm Vanilla Sugar Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5, Blue 1 Vanilla Bean Noel Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1 Merry Berry Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1 Peppermint Twist Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1 Kiss and Tell Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5 Spring Fling Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Chromium Hydroxide Green, Retinyl Palmitate, Yellow 5, Blue 1 Sweet Cherry Blossom Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5 Spring Blossom Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Ultramarine, Retinyl Palmitate, Yellow 5, Blue 1" ], "purpose": [ "PURPOSE Anti-bacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. Flammable, keep away from fire or flame. Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. If contact occurs, rinse thoroughly with water. Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor." ], "questions": [ "QUESTIONS? 1-800-FDA-1088" ], "spl_product_data_elements": [ "Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- FERRIC OXIDE RED VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- FERRIC OXIDE RED VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- FERRIC OXIDE RED VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- HYPROMELLOSE 2208 (100 MPA.S) VITAMIN A PALMITATE CHROMIC OXIDE FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- FERRIC OXIDE RED VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Anti-bacterial Hand Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYSORBATE 20 TROLAMINE LACTOSE .ALPHA.-TOCOPHEROL ACETATE, D- ULTRAMARINE BLUE VITAMIN A PALMITATE FD&C YELLOW NO. 5 FD&C BLUE NO. 1" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DIRECTIONS Apply to hands until thoroughly wet. Rub vigorously until dry. Supervise children in the use of this product." ], "spl_unclassified_section": [ "Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2010 ShopKo Stores Operating Co., LLC" ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Sweet Cherry Blossom anti-bacterial hand gel PARABEN FREE contains aloe vera and vitamins A & E 1 fl oz Sweet Cherry Blossom Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Warm Vanilla Sugar anti-bacterial hand gel PARABEN FREE contains aloe vera and vitamins A & E 1 fl oz Warm Vanilla Sugar Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Vanilla Bean Noel anti-bacterial hand gel 1 fl oz Vanilla Bean Noel Bottle Label principal display panel - vanilla bean noel bottle label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Merry Berry anti-bacterial hand gel 1 fl oz Merry Berry Bottle Label principal display panel - merry berry bottle label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Peppermint Twist anti-bacterial hand gel 1 fl oz Peppermint Twist Bottle Label principal display panel - peppermint twist bottle label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Kiss and tell anti-bacterial hand gel 1 fl oz Kiss and tell Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Spring fling anti-bacterial hand gel 1 fl oz Spring fling Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Sweet cherry blossom anti-bacterial hand gel 1 fl oz Sweet cherry blossom Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath-body-etc ® Spring Blossom anti-bacterial hand gel 1 fl oz Spring Blossom Bottle Label Bottle Label" ], "indications_and_usage": [ "USE To decrease bacteria on the skin and clean hands. Recommended for repeated use." ], "set_id": "733e761c-65b8-4b33-b3d1-a341397cbed3", "id": "1d8ea7b6-6953-4176-85c2-1de2ac2978b4", "active_ingredient": [ "ACTIVE INGREDIENT Ethyl Alcohol 62% w/w" ] }, { "effective_time": "20131217", "inactive_ingredient": [ "Inactive ingredients Berry Vanilla Flavor, Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Sucralose." ], "purpose": [ "Purpose Cough Suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not exceed recommended dosage." ], "questions": [ "Questions? Comments? Call 1-888-535-0305" ], "spl_product_data_elements": [ "VANACOF G Chlophedianol Hydrochloride, Guaifenesin Chlophedianol Hydrochloride Chlophedianol Guaifenesin Guaifenesin CITRIC ACID MONOHYDRATE Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol Sucralose" ], "ask_doctor": [ "Ask a doctor before use if you have asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in a 24 hour period Children 6 to under 12 years of age: 1/2 teaspoonful every 6 hours, not to exceed 2 teaspoonfuls in a 24 hour period Children under 6 years of age Consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur" ], "storage_and_handling": [ "Other information Store at 59°- 86°F (15°- 30°C)" ], "package_label_principal_display_panel": [ "Product Packaging The packaging below represents labeling currently used: Principal display panel and side panel for 473 mL label: NDC 58809-571-01 VANACOF G EACH 5 mL (1 TEASPOONFUL) CONTAINS: Chlophedianol Hydrochloride........................25 mg Guaifenesin..............................................200 mg Cough Suppressant / Expectorant Alcohol Free / Gluten Free Sugar Free / Dye Free Berry Vanilla Flavor 16 fl. oz. (473 mL) GM Pharmaceuticals, Inc. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER. Dispense in a tight, light-resistant container with a child-resistant cap. Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76012 Patent Pending Rev. 04/11 VANACOF G Packaging VANACOF G Packaging" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold: cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive" ], "set_id": "77009fed-343a-4d0a-b53c-47be4ac87121", "id": "c9698627-ad4a-46fd-9fe6-02fe0d3c5868", "active_ingredient": [ "Drug Facts Active ingredients (in each 5 mL teaspoonful) Chlophedianol Hydrochloride 25 mg Guaifenesin 200 mg" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and over: 1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age: 1/2 teaspoonful every 6 hours, not to exceed 2 teaspoonfuls in a 24 hour period
Children under 6 years of age Consult a doctor
" ] }, { "effective_time": "20150608", "inactive_ingredient": [ "INACTIVE INGREDIENT INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone, Niacinamide, Cetyl Ethylhexanoate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Pentylene Glycol, Sorbitan Isostearate, Isoamyl p-Methoxycinnamate, Iron Oxides (CI 77492), Disteardimonium Hectorite, Magnesium Sulfate, Mica (CI 77019), Aluminum Hydroxide, PEG-8 Dimethicone, Phenoxyethanol, Glyceryl Tribehenate/Isostearate/Eicosandioate, Stearic Acid, Iron Oxides (CI 77491), Tribehenin, Fragrance(Parfum), Iron Oxides (CI 77499), Dimethicone, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Ethylhexylglcerin, Adenosine, Hydrogenated Castor Oil Isostearate, Disdoium EDTA, Cyclomethicone, Polysilicone-11, Lauroyl Lysine, Trehalose, Lavandula Angustifolia (Lavender) Flower Water, Ethylhexyl Palmitate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Silica Dimethyl Siylate, Lecithin, Pistacia Lentiscus (Mastic) Gum, Ceramide 3, Caprylyl Glycol, Actinidia Polygama Fruit Extract, Portulaca Oleracea Extract, Citric Acid, Vanilla Planifolia Fruit Extract, Sodium Benzoate, Sodium Hyaluronate, Potassium Sorbate, Hexylene Glycol, Caprylhydroxamic Acid" ], "purpose": [ "PURPOSE PURPOSE: Sunscreen" ], "warnings": [ "WARNINGS WARNINGS: If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes." ], "spl_product_data_elements": [ "Cover 10 Perfect BB Natural Titanium Dioxide, Octinoxate, Zinc Oxide Titanium Dioxide TITANIUM DIOXIDE Octinoxate OCTINOXATE Zinc Oxide ZINC CATION Water Glycerin" ], "description": [ "INDICATIONS & USAGE INDICATIONS & USAGE: Spread gently onto face and blend to desired coverage." ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton" ], "set_id": "7c7989fb-7bc3-4949-89fd-5ab15acc7d3b", "id": "ca55e828-cb3b-487e-b1da-40eed32a65b5", "active_ingredient": [ "ACTIVE INGREDIENT ACTIVE INGREDIENTS: Titanium Dioxide (CI 77891) (15.71%), Ethylhexyl Methoxycinnamate (7.0%), Zinc Oxide (CI 77947) (3.91%)" ] }, { "effective_time": "20120223", "inactive_ingredient": [ "Inactive ingredients Aloe barbadensis leaf juice (aloe, water), Capric caprylic triglycerides (coconut oil), Butyrospermum parkii (shea butter), Glyceryl stearate, Glycerin, Cetyl alcohol (coconut oil), Jojoba oil, Ethyl hexyl palmitate (palm oil), Morinda citrifolia (noni juice), Calendula officinalis (calendula) flower extract, Panthenol (provitamin B5), Polyglyceryl-3 stearate (vegetable glycerin/palm oil), Alpha tocopherol (vitamin E), Allantoin (vegetable), Sodium PCA (amino acid), Hyaluronic acid, Phenethyl alcohol and Ethyl hexyl glycerin (plant-based preservatives), Vanilla planifolia (vanilla) extract, Green tea extract" ], "purpose": [ "Purpose Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of children’s reach. If ingested seek medical help immediately." ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Lavanila Laboratories The Healthy Sunscreen SPF 40 Face Zinc Oxide, Titanium Dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ALOE VERA LEAF COCONUT OIL SHEA BUTTER GLYCERYL MONOSTEARATE GLYCERIN CETYL ALCOHOL JOJOBA OIL ETHYLHEXYL PALMITATE CALENDULA OFFICINALIS FLOWER PANTHENOL ALPHA-TOCOPHEROL ALLANTOIN SODIUM PYRROLIDONE CARBOXYLATE HYALURONIC ACID PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN VANILLA GREEN TEA LEAF" ], "warnings_and_cautions": [ "Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or redness develops and lasts." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Apply evenly to face and neck 15 minutes prior to sun exposure. Reapply as needed and after swimming or vigorous activity. Children under six months old: consult a physician." ], "package_label_principal_display_panel": [ "Image of Label LavanilaSPF40sunscreen.jpg Label" ], "indications_and_usage": [ "Uses Helps prevent sunburn Can reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures." ], "set_id": "7e168cd9-3c96-4f50-a0b9-c7b26b28b935", "id": "9398cb04-8ce8-49cd-b312-e71681a3b83a", "active_ingredient": [ "Active ingredients Zinc Oxide 5.0%, Titanium Dioxide 7.5%" ] }, { "effective_time": "20120510", "inactive_ingredient": [ "Ricinus Communis (Castor) Seed Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Lanolin, Copernicia Cerifera (Carnauba) Wax, Glycine Soja (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Olea Europaea (0live)Fruit Oil, Echinacea Purpurea Extract, Vanilla Planifolia Fruit Extract, Ammonium Glycyrrhizate, Tocopherol, Tocopheryl Acetate. (1) Certified Organic Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if skin rash occurs." ], "questions": [ "Questions? Call 888-659-7730 or visit www.AlbaBotanica.com" ], "spl_product_data_elements": [ "Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm Ethylhexyl Dimethyl PABA, Benzophenone-3 PADIMATE O PADIMATE O OXYBENZONE OXYBENZONE CASTOR OIL YELLOW WAX CANDELILLA WAX JOJOBA OIL LANOLIN CARNAUBA WAX SOYBEAN OIL EVENING PRIMROSE OIL OLIVE OIL ECHINACEA PURPUREA AMMONIUM GLYCYRRHIZATE TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE COCONUT OIL VANILLA" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 mos ask a doctor. Skin Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging." ], "package_label_principal_display_panel": [ "image of container label image of carton label" ], "indications_and_usage": [ "Helps prevent sunburn" ], "set_id": "88b44518-5dc8-4791-92f3-eed4b70061e1", "id": "30695b6c-a104-441c-bc7b-39b6e86fcfc2", "active_ingredient": [ "Ethylhexyl Dimethyl PABA 7.5% Benzophenone-3 5.0%" ] }, { "effective_time": "20150817", "inactive_ingredient": [ "Inactive ingredients ricinus communis (castor) seed oil, oleic/linoleic/linolenic polyglycerides, beeswax, simmondsia chinensis (jojoba) seed oil, flavor, silica, lecithin, jojoba esters, polyhydroxystearic acid, tocopherol [vitamin E], vanilla planifolia fruit extract, iron oxides, mica, titanium dioxide" ], "purpose": [ "Purpose Zinc oxide - Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Stop use and ask doctor if • rash or irritation develops and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com" ], "spl_product_data_elements": [ "Softlips Pure Lip Gloss Natural zinc oxide ZINC OXIDE ZINC OXIDE WHITE WAX" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply liberally before sun exposure and as needed • children under 6 months of age: ask a doctor" ], "stop_use": [ "Stop use and ask doctor if • rash or irritation develops and lasts" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Softlips Pure Natural Honesty Sheer Lip Gloss Color inspired by nature 100% natural Softlips Pure Natural Honesty Sheer Lip Gloss Color Inspired By Nature 100% Natural" ], "indications_and_usage": [ "Uses • helps prevent sunburn • provides UVA and UVB protection" ], "set_id": "8ae990a7-9009-4494-97aa-4cc013a9e704", "id": "70305aa5-9710-4111-b262-cb1fd693971d", "active_ingredient": [ "Active ingredient Zinc oxide 6.5%" ] }, { "effective_time": "20110823", "inactive_ingredient": [ "Inactive ingredients Glycerin, Orange-Vanilla Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol." ], "purpose": [ "Purpose Antihistamine Cough Suppressant Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not exceed recommended dosage. Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness" ], "questions": [ "Questions? Comments? 1-888-455-5253 , M-F: 8:00 a.m. - 5:00 p.m. CST Serious side effects associated with use of this product may be reported to this number. Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110" ], "spl_product_data_elements": [ "Nasohist DM Pediatric Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Chlorpheniramine Maleate Chlorpheniramine Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Administer each dose four times per day using provided dropper. Do not exceed recommended dosage AGE DOSE* Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hrs. Children under 6 years of age: Consult a physician *In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur" ], "storage_and_handling": [ "Other information Store at Controlled Room Temperature 20 o -25 o C (68 o -77 o F); excursions permitted 15 o -30 o C (59 o -86 o F). [See USP Controlled Room Temperature]." ], "do_not_use": [ "Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING: The packaging below represents the labeling currently used: Principal Display Panel and Side Panel for 30 mL Label: NDC 63717-291-30 Nasohist DM pediatric drops Antihistamine / Cough Suppressant Nasal Decongestant Each dropperful (1 mL) for oral administration contains: Chlorpheniramine Maleate.....1 mg Dextromethorphan HBr......... 3 mg Phenylephrine HCl............... 2 mg Sugar Free / Alcohol Free Dye Free 1 fl oz (30 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Supplied in a tight, light-resistant container with a child-resistant cap. See package insert for full prescribing information. Mfg for: Hawthorn Pharmaceuticals, Inc. Madison, MS 3910 HL177 Rev. 10/09 Principal Display Panel and Side Panel for 30 mL Sample Label: NDC 63717-291-99 Nasohist DM pediatric drops Antihistamine / Cough Suppressant Nasal Decongestant Each dropperful (1 mL) for oral administration contains: Chlorpheniramine Maleate..... 1 mg Dextromethorphan HBr.......... 3 mg Phenylephrine HCl................ 2 mg Professional Sample: Not for Sale Sugar Free / Alcohol Free Dye Free 1 fl oz (30 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Supplied in a tight, light-resistant cotainer with a child-resistant cap. See package insert for full prescribing information. Mfg for: Hawthorn Pharmaceuticals, Inc. Madison, MS 39110 HL179 Rev. 09/09 Nasohist DM Pediatric Drops Packaging Nasohist DM Pediatric Drops Packaging Nasohist DM Pediatric Drops Packaging Nasohist DM Pediatric Drops Packaging Nasohist DM Pediatric Drops Packaging Nasohist DM Pediatric Drops Packaging" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages" ], "set_id": "8ff107d5-a716-40f3-8d63-f6732bd49e0b", "id": "47efcdec-05a3-47ad-85f1-eb8231ffc27a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers." ], "active_ingredient": [ "Drug Facts Active ingredients (in each 1 mL dropperful) Chlorpheniramine Maleate, USP 1 mg Dextromethorphan Hydrobromide, USP 3 mg Phenylephrine Hydrochloride, USP 2 mg Purpose Antihistamine Cough Suppressant Nasal Decongestant" ], "dosage_and_administration_table": [ "
AGE DOSE*
Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hrs.
Children under 6 years of age: Consult a physician
" ] }, { "effective_time": "20100609", "inactive_ingredient": [ "Inactive Ingredients WATER/EAU SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE GLYCERIN COCAMIDE MEA SODIUM CHLORIDE PARFUM/FRAGRANCE POLYSORBATE 20 DISODIUM EDTA PEG-150 DISTEARATE BENZOPHENONE-3 PHOSPHORIC ACID METHYLCHLOROISOTHIAZOLINONE VANILLA PLANIFOLIA FRUIT EXTRACT GLYCINE SOJA (SOYBEAN) SEED EXTRACT METHYLISOTHIAZOLINONE HYDROLYZED MILK PROTEIN ORANGE 4/CI 15510" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away." ], "warnings": [ "Warnings For external use only When using this product: Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a healthcare practitioner if irritation and redness develop Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away." ], "when_using": [ "When using this product: Avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "questions": [ "Questions? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada" ], "spl_product_data_elements": [ "Naturals Antibacterial Liquid Soap Vanilla TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE GLYCERIN SODIUM CHLORIDE POLYSORBATE 20 PEG-150 DISTEARATE PHOSPHORIC ACID METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE" ], "ask_doctor": [ "Stop use and ask a healthcare practitioner if irritation and redness develop" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Pump a generous amount of soap onto wet hands and work into a rich lather. Wash, rinse and dry thoroughly. Use as part of daily cleansing routine." ], "package_label_principal_display_panel": [ "image of PDP image of back label image of back label" ], "indications_and_usage": [ "Uses for handwashing to decrease certain bacteria on the skin" ], "set_id": "8ff3e7db-01f7-4324-b7e5-11c0ef4a9da0", "id": "10cbc80c-e5f8-468b-b78a-e6f428eea8ac", "active_ingredient": [ "Active ingredient Purpose Triclosan 0.20%..................................Antiseptic handwash" ] }, { "effective_time": "20100309", "inactive_ingredient": [ "Inactive ingredients Crosscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor." ], "purpose": [ "Purpose Antiemetic" ], "warnings": [ "Warnings Do not take this product if you have asthma, glaucoma, emphysema, chronic pulmonary disease, shortness of breath, difficulty in breathing, or difficulty in urination due to enlargement of the prostate gland, unless directed by a physician. Do not give to children under 12 years of age unless directed by a physician. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." ], "spl_product_data_elements": [ "SEA-CALM Meclizine HCl 25mg Chewable Tablets MECLIZINE HYDROCHLORIDE MECLIZINE SILICON DIOXIDE FD&C RED NO. 40 LACTOSE CROSPOVIDONE CROSCARMELLOSE SODIUM RASPBERRY VANILLA SACCHARIN SODIUM MAGNESIUM STEARATE STEARIC ACID BMS" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adult oral dosage is one to two tablets once daily or as directed by a physician." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Container Label for SEA-CALM Packet - 2 Tablets" ], "indications_and_usage": [ "Uses For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness" ], "set_id": "9377d7c1-23da-404a-9676-f50e148d9521", "id": "9377d7c1-23da-404a-9676-f50e148d9521", "active_ingredient": [ "Active ingredient Meclizine Hydrochloride 25 mg" ] }, { "effective_time": "20150216", "inactive_ingredient": [ "Inactives TEA TREE OIL EUCALYPTUS POLYBRACTEA LEAF OIL CITRONELLA OIL LEPTOSPERMUM PETERSONII LEAF OIL VANILLA ACTILASTIN 1000" ], "purpose": [ "Purpose Sunscreen, helps prevent sunburn." ], "warnings": [ "Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center immediately. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor" ], "spl_product_data_elements": [ "Outback 2 in 1 Protection OCTINOXATE,AVOBENZONE and ZINC OXIDE OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE ZINC OXIDE ZINC CATION TEA TREE OIL EUCALYPTUS POLYBRACTEA LEAF OIL CITRONELLA OIL LEPTOSPERMUM PETERSONII LEAF OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions of Usage Apply liberally 15 minutes before sun exposure, reapply after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours." ], "package_label_principal_display_panel": [ "Product Label sunscreen" ], "set_id": "95adf725-b16a-4617-bbe3-105b82de3961", "id": "f7473b9a-663a-4b24-b603-69f765faa818", "active_ingredient": [ "Active Ingredients OCTINOXATE : 7.5 % AVOBENZONE : 1.3% ZINC OXIDE :9.5%" ] }, { "effective_time": "20111020", "inactive_ingredient": [ "INGREDIENTS: WATER\\AQUA\\EAU [] PEG-4 DIHEPTANOATE [] GLYCERIN [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PHENYL TRIMETHICONE [] POLYETHYLENE [] CETEARYL ALCOHOL [] DIMETHICONE [] TOCOPHERYL ACETATE [] CETYL ALCOHOL [] GLYCERYL STEARATE [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] VANILLA PLANIFOLIA FRUIT EXTRACT [] DIPTERYX ODORATA SEED EXTRACT [] SAPINDUS MUKUROSSI FRUIT EXTRACT [] MORINDA CITRIFOLIA FRUIT EXTRACT [] COCOS NUCIFERA (COCONUT) OIL [] POGOSTEMON CABLIN (PATCHOULI) OIL [] CANANGA ODORATA FLOWER OIL [] AMYRIS BALSAMIFERA BARK OIL [] VETIVERIA ZIZANOIDES ROOT OIL [] CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] LECITHIN [] CAFFEINE [] CAESALPINIA SPINOSA GUM [] PROPYLENE GLYCOL LAURATE [] SQUALANE [] SORBITAN STEARATE [] PEG-40 STEARATE [] HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER [] ETHYLHEXYLGLYCERIN [] BUTYLENE GLYCOL [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] XANTHAN GUM [] POLYSORBATE 60 [] PROPYLENE GLYCOL STEARATE [] SODIUM HYALURONATE [] SORBITAN LAURATE [] POTASSIUM SORBATE [] POLYSORBATE 20 [] CITRIC ACID [] TIN OXIDE [] TETRASODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] LINALOOL [] LIMONENE [] CHLORPHENESIN [] PHENOXYETHANOL [] [+/- TITANIUM DIOXIDE (CI 77891) [] MICA]" ], "warnings": [ "WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL: TF TOM FORD ILLUMINATING PROTECTIVE PRIMER SPF 12 1 OZ./FL.OZ./30 ML TOM FORD BEAUTY DIST NEW YORK, NY 10022 FOLDING CARTON" ], "spl_product_data_elements": [ "ILLUMINATING PROTECTIVE PRIMER SPF 12 OCTINOXATE, HOMOSALATE OCTINOXATE OCTINOXATE HOMOSALATE HOMOSALATE WATER GLYCERIN SHEA BUTTER PHENYL TRIMETHICONE CETOSTEARYL ALCOHOL DIMETHICONE ALPHA-TOCOPHEROL ACETATE CETYL ALCOHOL GLYCERYL MONOSTEARATE EPILOBIUM ANGUSTIFOLIUM LEAF VANILLA DIPTERYX ODORATA SEED SAPINDUS MUKOROSSI FRUIT COCONUT OIL PATCHOULI OIL CANANGA OIL AMYRIS BALSAMIFERA OIL VETIVER OIL BERGAMOT OIL EVENING PRIMROSE OIL LECITHIN, SOYBEAN CAFFEINE CAESALPINIA SPINOSA RESIN PROPYLENE GLYCOL LAURATES SQUALANE SORBITAN MONOSTEARATE PEG-40 STEARATE ETHYLHEXYLGLYCERIN BUTYLENE GLYCOL DIHEXADECYL PHOSPHATE CETETH-10 PHOSPHATE XANTHAN GUM POLYSORBATE 60 HYALURONATE SODIUM SORBITAN MONOLAURATE POTASSIUM SORBATE POLYSORBATE 20 CITRIC ACID MONOHYDRATE STANNIC OXIDE EDETATE SODIUM CHLORPHENESIN PHENOXYETHANOL TITANIUM DIOXIDE MICA" ], "set_id": "96b3109c-0f1b-48c6-9f97-4e7c621a9060", "id": "c08ab60d-9dea-4c24-9951-3baf4a1da91b", "openfda": {}, "version": "1", "active_ingredient": [ "ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] HOMOSALATE 5.00%" ] }, { "effective_time": "20140304", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), FRAGRANCE (PARFUM), PROPYLENE GLYCOL, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAMELLIA SINENSIS LEAF EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)" ], "purpose": [ "PURPOSE ANTISEPTIC" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "questions": [ "QUESTIONS/COMMENTS? 1-866-695-3030" ], "spl_product_data_elements": [ "ORCHID BY H E B VANILLA BROWN SUGAR ETHYL ALCOHOL ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL CARBOMER 934 GLYCERIN AMINOMETHYLPROPANOL MANNITOL POWDERED CELLULOSE HYPROMELLOSES ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES GREEN TEA LEAF VANILLA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE FD&C YELLOW NO. 5 D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "storage_and_handling": [ "OTHER INFORMATION STORE AT A TEMPERATURE BELOW 110°F (43°C)" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE BACTERIA ON THE SKIN" ], "set_id": "97dade5b-8370-4210-9fbe-130019717106", "id": "491e9055-7981-4d56-9acf-3b267e8eab0c", "active_ingredient": [ "ACTIVE INGREDIENT ETHYL ALCOHOL 65% PURPOSE ANTISEPTIC" ] }, { "effective_time": "20091229", "inactive_ingredient": [ "Inactive/Non-medicinal ingredients WATER/EAU SD ALCOHOL 40-B DIMETHICONE POLYSORBATE 20 GLYCERIN PYRUS MALUS (APPLE) FRUIT EXTRACT VANILLA PLANIFOLIA FRUIT EXTRACT ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT SPIRAEA ULMARIA EXTRACT CINNAMOMUM CASSIA BARK EXTRACT CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER ISOHEXADECANE XANTHAN GUM TRIMETHYLSILOXYSILICATE POLYMETHYL METHACRYLATE SILICA POLYSORBATE 60 TALC SORBITAN ISOSTEARATE CAPRYLIC/CAPRIC TRIGLYCERIDE ISOPROPYL MYRISTATE DIPROPYLENE GLYCOL PYRIDOXINE HCL DISODIUM EDTA BENZYL ALCOHOL" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only When using this product avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists, seek medical attention using other topical acne products at the same time or immediately after use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists, seek medical attention using other topical acne products at the same time or immediately after use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a doctor." ], "questions": [ "Questions? Call 1-800-meetmark" ], "spl_product_data_elements": [ "MARK. Break Out Plan Salicylic Acid SALICYLIC ACID SALICYLIC ACID" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions cleanse skin thoroughly before applying medication because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day" ], "package_label_principal_display_panel": [ "image of carton label" ], "indications_and_usage": [ "Uses helps in the treatment of acne helps prevent new acne blemishes from forming clears up acne blemishes penetrates pores to eliminate most blackheads and acne pimples" ], "set_id": "987932c4-e880-40c1-92e1-55fada880a2c", "id": "42816e46-aaec-483d-8e12-2a01051bf501", "active_ingredient": [ "See attached 1092906 breakout plan FC.jpg Active ingredient Purpose Salicylic Acid 1.5%....................................Acne Treatment" ] }, { "effective_time": "20150113", "inactive_ingredient": [ "Inactive ingredients Glycerin, Orange-Vanilla Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol." ], "purpose": [ "Purpose Antihistamine Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not exceed recommended dosage." ], "when_using": [ "When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness" ], "questions": [ "Questions? Comments? 1-888-455-5253 M-F: 8:00 a.m. - 5:00 p.m. CST Serious side effects associated with use of this product may be reported to this number. Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110" ], "spl_product_data_elements": [ "Nasohist Pediatric Chlorpheniramine Maleate, Phenylephrine Hydrochloride Chlorpheniramine Maleate Chlorpheniramine Phenylephrine Hydrochloride Phenylephrine Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Administer each dose four times per day using provided dropper. Do not exceed recommended dosage. AGE DOSE* Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a physician. *In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by a fever new symptoms occur" ], "storage_and_handling": [ "Other information Store at controlled room temperature 20°- 25°C (68°- 77°F); excursions permitted 15°- 30°C (59°- 86°F). [See USP Controlled Room Temperature]." ], "do_not_use": [ "Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product" ], "package_label_principal_display_panel": [ "Product Packaging The packaging below represents labeling currently used: Principal display panel and side panel for 30 mL label: NDC 63717-326-30 nasohist pediatric drops Each dropperful (1 mL) for oral administration contains: Chlorpheniramine Maleate...............................1 mg Phenylephrine Hydrochloride...........................2 mg Antihistamine / Nasal Decongestant Sugar-Free / Alcohol Free / Dye Free HAWTHORN PHARMACEUTICALS, INC. 1 fl oz (30 mL) Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken. Supplied in a tight, light-resistant closure. Manufactured for: Hawthorn Pharmaceuticals, Inc. Madison, MS 39110 HL178 Rev. 05/11 Nasohist Pediactric Drops Packaging Nasohist Pediatric Drops Packaging Nasohist Pediatric Drops Packaging" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages" ], "set_id": "9939fcdc-efea-4922-ab94-c2d0400fa7f2", "id": "fc0ecfd0-842f-403d-a819-16c4d919325a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers." ], "active_ingredient": [ "Drug Facts Active ingredients (in each 1 mL dropperful) Chlorpheniramine Maleate, USP 1 mg Phenylephrine Hydrochloride, USP 2 mg" ], "dosage_and_administration_table": [ "
AGE DOSE*
Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hours, or as directed by a doctor.
Children under 6 years of age: Consult a physician.
" ] }, { "effective_time": "20150318", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients: Water, Limanathes alba (meadowfoam) seed oil, Glycerin, Shea Butter, Tremella Fuciformis Extract, Vanilla planifolia fruit Extract, Ceratonia siliqua (carob) fruit Extract, Rubus Futicosus Fruit Extract, Cetearyl olivate, Sorbitan olivate, Cetostearyl Alcohol, Cetearyl Polyglucose, Artemisia annua extract, Calendula officinalis flower extract, Symphytum officinale leaf extract, Herichrysum angustiforium flower extract, Azadirachta indica leaf extract, Zanthoxylum piperitum fruit extract/Pullsatilla koreana extract, Usnea barbata extract, Adenosine, Allantoin, Pantothenol, Aronia Melanocarpa Fruit Extract, Olea Europaea (Olive) Leaf Extract , Citrus Junos Fruit Extract , Uncaria Tomentosa Extract, Inonotus Obliquus (Mushroom) Extract, Euterpe Oleracea Fruit Extract, Lepidium Meyenii Root Extract, Vaccinium Myrtillus Fruit Extract, Yucca Vera Extract, Taraxacum Officinale (Dandelion) Extract, Sarcodon Aspratus Extract, Aristotelia Chilensis Fruit Extract, Asimina Triloba Fruit Extract, Morinda Citrifolia Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Fruit Extract, 1.2-Hexanediol, Caprylyl glycol, Citrus aurantium amara flower oil" ], "purpose": [ "PURPOSE Purpose: Skin Protectant" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "Cautions Cautions: For external use only. Avoid contact with eyes and mouth. Discountinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use." ], "spl_product_data_elements": [ "TREEANNSEA ESKIMO MELLA TIME RELEASE AGE DEFINE Witch Hazel Witch Hazel WITCH HAZEL Water Glycerin" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION How to use: After using Toner and Essence gently apply on entire face and tap for better absorption." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton" ], "indications_and_usage": [ "INDICATIONS & USAGE How to use: After using Toner and Essence gently apply on entire face and tap for better absorption." ], "set_id": "99784499-81a8-4687-beab-b5a521bbc771", "id": "27faa897-bd9b-4711-9fef-4ce7a70eaeb2", "active_ingredient": [ "ACTIVE INGREDIENT Active Ingredients: Hamamelis Virginiana (Witch Hazel) Water 0.05%" ] }, { "effective_time": "20111117", "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredients: Hydrogenated Coconut Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Fragrance, Olea Europaea (Olive) Fruit Oil, Flavor, Tocopheryl Acetate, Ammonium Glycyrrhizate, Glycine Soja (Soybean) Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Lecithin, Rosmarinus Officinalis (Rosemary) Leaf Extract. Vanilla Mint label" ], "purpose": [ "Purpose lip moisturizer helps prevent sunburn higher SPF gives more sunburn protection" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If swallowed get medical help or contact Poison Control right away." ], "warnings": [ "Warning Warnings For external use only" ], "when_using": [ "When using this product When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Gap Favorite Lip Balm Vanilla Mint SPF Octinoxate and Oxybenzone OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE HYDROGENATED COCONUT OIL OLIVE OIL YELLOW WAX CANDELILLA WAX CALENDULA OFFICINALIS FLOWER TOCOPHEROL ALPHA-TOCOPHEROL ACETATE ROSEMARY ECHINACEA, UNSPECIFIED AMMONIUM GLYCYRRHIZATE VANILLA MINT" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply liberally before sun exposure and as needed children under 6 months of age: ask doctor" ], "stop_use": [ "Stop use Stop use ans ask doctor if rash and irritation develops and lests" ], "general_precautions": [ "Sun Alert Other Information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin cancer, and other harmful effects of the sun." ], "package_label_principal_display_panel": [ "Label" ], "set_id": "9c834991-6f5f-471d-8335-bdf6349e50e5", "id": "c679096d-25ca-4381-aed0-111701137af7", "active_ingredient": [ "Active Ingredients Active Ingredients Purpose Octinoxate 7.5% Sunscreen Oxybenzone 6% Sunscreen" ] }, { "effective_time": "20110823", "inactive_ingredient": [ "Inactive ingredients Glycerin, Orange-Vanilla Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol." ], "purpose": [ "Purpose Antihistamine Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not exceed recommended dosage. Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by a fever new symptoms occur Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness" ], "questions": [ "Questions? Comments? 1-888-455-5253 M-F: 8:00 a.m. - 5:00 p.m. CST Serious side effects associated with use of this product may be reported to this number. Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110" ], "spl_product_data_elements": [ "Nasohist Pediatric Chlorpheniramine Maleate and Phenylephrine Hydrochloride Chlorpheniramine Maleate Chlorpheniramine Phenylephrine Hydrochloride Phenylephrine Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Administer each dose four times per day using provided dropper. Do not exceed recommended dosage. AGE DOSE* Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hours Children under 6 years of age: Consult a physician *In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by a fever new symptoms occur" ], "storage_and_handling": [ "Other information Store at controlled room temperature 20-25 o C (68-77 o F); excursions permitted 15-30 o C (59-86 o F). [See USP Controlled Room Temperature]." ], "do_not_use": [ "Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING: The packaging below represents the labeling currently used: Principal Display Panel and Side Panel for 30 mL Label: NDC 63717-290-30 Nasohist pediatric drops Each dropperful (1 mL) for oral administration contains: Chlorpheniramine Maleate........ 1 mg Phenylephrine Hydrochloride.... 2 mg Antihistamine / Nasal Decongestant Sugar-Free / Alcohol Free / Dye Free Hawthorn Pharmaceuticals, Inc. 1 fl oz (30 mL) Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken. Supplied in a tight, light-resistant container with a child-resistant closure. Manufactured for: Hawthorn Pharmaceuticals, Inc. Madison, MS 39110 HL178 Rev. 11/09 Nashohist Pediatric Drops Packaging Nasohist Pediatric Drops Packaging Nasohist Pediatric Drops Packaging" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages" ], "set_id": "9d5f7d8b-2447-44b6-9304-497a99c94ea4", "id": "6e47bb4d-af0e-4217-9ab8-765e63f2d644", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers" ], "active_ingredient": [ "Drug Facts Active ingredients (in each 1 mL dropperful) Chlorpheniramine Maleate, USP 1 mg Phenylephrine Hydrochloride, USP 2 mg Purpose Antihistamine Decongestant" ], "dosage_and_administration_table": [ "
AGE DOSE*
Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hours
Children under 6 years of age: Consult a physician
" ] }, { "effective_time": "20140113", "inactive_ingredient": [ "Ingredients = Certified Organic Helianthus Annuus ( Sunflower ) Oil, Cera Alba ( Beeswax ), Essential Oils of Citrus Aurantium Dulcis ( Sweet Orange ) and Citrus Tangerina ( Tangerine ), Tocopherol ( Sunflower Vitamin E ), CO 2 Extracts of Hippophae Rhamnoides ( Seabuckthorn ) and Vanilla Planifolia ( Vanilla )." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on damaged or broken skin. Stop and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Badger Kids SPF 30 Sunscreen ZINC OXIDE ZINC OXIDE ZINC OXIDE SUNFLOWER OIL YELLOW WAX TOCOPHEROL HIPPOPHAE RHAMNOIDES FRUIT ORANGE OIL MANDARIN OIL VANILLA" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions For full protection, apply liberally (2mg/cm 2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect. Reapply After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm Wear long-sleeved shirts, pants, hats, and sunglasses For children under 6 months of age: ask a doctor." ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other Information Store at temperatures below 90°F." ], "do_not_use": [ "Do not use on damaged or broken skin. Stop and ask a doctor if rash occurs." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 87 mL Tube Label Active BADGER ® Tangerine & Vanilla Broad Spectrum SPF 30 Kids ZINC OXIDE SUNSCREEN CREAM Safe • Effective • Hypoallergenic WATER RESISTANT 40 min UVA UVB NON NANO BIO DEGRADABLE NATURAL PRODUCTS ASSOCIATION • CERTIFIED • 100% CERTIFIED NATURAL 98% ORGANIC INGREDIENTS NSF contains organic ingredients 87ml/2.9 fl.oz PRINCIPAL DISPLAY PANEL - 87 mL Tube Label" ], "indications_and_usage": [ "Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "9f527715-dd39-4580-bbd2-a0397be36cd3", "id": "014285da-cd1b-484a-a259-dcd787233cbe", "active_ingredient": [ "Active Ingredient Non-Nano Uncoated Zinc Oxide 18.75%" ] }, { "effective_time": "20120813", "inactive_ingredient": [ "Water,Theobroma Oil, Olea Europaea Fruit Oil, Vitellaria Paradoxa, Simmondsia Chimensis Seed Oil, D-Alpha Tocopheryl Acetate,Vanilla Planifolia tincture, Allantoin, Sodium Benzoate, Potassium Sorbate, Cetyl Alcohol, Capryllic/Capric Triglyceride,Cetearyl Glucoside, Cetostearyl Alcohol, Bisabolol, Sclerotium Gum." ], "keep_out_of_reach_of_children": [ "Keep Out Of Reach Of Children. If swallowed,get medical help or contact a Poison Control Center immediately." ], "purpose": [ "Eczema Cream. For external use only." ], "warnings": [ "For External use only. When using this product do not get into eyes. If pregnant or breastfeeding, ask a professional before use. Stop use and ask doctor if conditions worsen, symptoms last more than 7days or clear up and occur again in a few days." ], "spl_product_data_elements": [ "GN Kids Eczema Oatmeal WATER COCOA BUTTER OLIVE OIL SHEANUT OIL JOJOBA OIL .ALPHA.-TOCOPHEROL, D- VANILLA ALLANTOIN SODIUM BENZOATE POTASSIUM SORBATE CETYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES CETEARYL GLUCOSIDE CETOSTEARYL ALCOHOL LEVOMENOL BETASIZOFIRAN OATMEAL OATMEAL" ], "openfda": {}, "version": "8", "dosage_and_administration": [ "Topical cream. Apply as needed to affected areas." ], "package_label_principal_display_panel": [ "image of box image of box" ], "indications_and_usage": [ "Eczema cream, apply to affected area." ], "set_id": "a12761e4-46c0-4eea-b5f3-ceccaea7efa3", "id": "9115b517-7163-4b7a-b471-94890e82ec4c", "active_ingredient": [ "COLLOIDAL OATMEAL" ] }, { "effective_time": "20110727", "inactive_ingredient": [ "inactive ingredients: canola oil [] beeswax (cera alba) [] lecithin [] mentha piperita (peppermint) essential oil (olea) [] cocos nucifera (coconut) oil [] vanilla planifolia [] aloe barbadensis (aloe) leaf juice [] lauroyl lysine [] tocopherol (vitamin e) [] aluminum stearate [] stearic acid" ], "warnings": [ "warning: stop use if signs of irritation appear and check with doctor." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL ORIGINS COVER YOUR MOUTH LIP PROTECTOR WITH SPF 8 NT WT 0.15 OZ./ 4.5 G origins natural resources inc. new york, ny 10022 FOLDING CARTON" ], "spl_product_data_elements": [ "COVER YOUR MOUTH SPF 8 LIP PROTECTOR TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE CANOLA OIL WHITE WAX LECITHIN, SOYBEAN PEPPERMINT OIL COCONUT OIL VANILLA LAUROYL LYSINE ALPHA-TOCOPHEROL ALUMINUM STEARATE STEARIC ACID" ], "set_id": "a500c915-7dc5-4d34-9fa3-a68abf834bb9", "id": "ff21882b-d525-4eeb-a88c-4c8c4d77fde2", "openfda": {}, "version": "1", "active_ingredient": [ "active ingredient: titanium dioxide 1.80%" ] }, { "effective_time": "20100611", "inactive_ingredient": [ "Inactive/Non-medicinal ingredients: WATER/EAU STEARETH-2 PPG-15 STEARYL ETHER GLYCINE SOJA (SOYBEAN) SEED EXTRACT VANILLA PLANIFOLIA FRUIT EXTRACT HYDROLYZED MILK PROTEIN DICAPRYL ADIPATE STEARETH-20 ISOPROPYL PALMITATE PARFUM/FRAGRANCE" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only When using this product • do not apply to broken skin • stop use if rash or irritation develops Ask a doctor before use • if you have kidney disease Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • do not apply to broken skin • stop use if rash or irritation develops" ], "questions": [ "Questions? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada" ], "spl_product_data_elements": [ "Naturals Vanilla Anti-Perspirant Deodorant Aluminum Chlorohydrate Aluminum Chlorohydrate ALUMINUM CATION WATER STEARETH-2 STEARETH-20 ISOPROPYL PALMITATE" ], "ask_doctor": [ "Ask a doctor before use • if you have kidney disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply to underarms only" ], "package_label_principal_display_panel": [ "image of PDP image of back label" ], "indications_and_usage": [ "Uses • reduces underarm perspiration • lasts 24 hours" ], "set_id": "a83012c8-2451-4b66-b2f7-2aec92879aca", "id": "2d7176bc-35f2-4365-9bad-1378673c387f", "active_ingredient": [ "Active/ Medicinal ingredient Purpose Aluminum Chlorohydrate 14.5%, anhydrous...................Antiperspirant" ] }, { "effective_time": "20130808", "inactive_ingredient": [ "Inactive ingredients D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH." ], "purpose": [ "Purpose Stool Softener Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "questions": [ "Questions or comments? Call 1-855-333-6337 To Report suspected adverse reactions, contact the FDA at 1-800-FDA-1088" ], "spl_product_data_elements": [ "DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE D&C RED NO. 33 METHYLPARABEN POLOXAMER 181 POLYETHYLENE GLYCOLS PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM BENZOATE SODIUM CITRATE natural and artificial vanilla flavor" ], "ask_doctor": [ "Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks." ], "other_safety_information": [ "Other information each teaspoon contains: sodium 5 mg shake well before using store at controlled room temperature 15° - 30°C (59° - 86°F) dispense contents in a tight, light resistant container as defined in the USP." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions may be taken once daily or in divided doses give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation adults and children over 12 5 to 35 mL (1 to 7 teaspoons) children 6 to under 12 5 to 15 mL (1 to 3 teaspoons) children 2 to under 6 2.5 to 5 mL (1/2 to 1 teaspoon) children under 2 ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Repackaged by: Safecor Health, LLC 317 New Boston St. Woburn, MA 01801 Distributed by: LLC Federal Solutions 14 NE 1st Ave. Miami, FL 33132 REV 105-00 07/2013" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use of this product These may indicate a serious condition." ], "do_not_use": [ "Do not use if you are presently taking mineral oil when abdominal pain, nausea, or vomiting are present for longer than one week" ], "package_label_principal_display_panel": [ "———PRINCIPAL DISPLAY PANEL——— NDC: 24451-771-25 DOCUSATE SODIUM 250 mg / 25 mL (DOCU LIQUID) DELIVERS 25 mL SHAKE WELL BEFORE USING Exp: 00/00/00 Lot # 00000 Rpk By: Safecor Health LLC Woburn, MA 01801 Dist. By: LLC Federal Solutions Miami, FL 33132 Product Label" ], "indications_and_usage": [ "Use For relief of occasional constipation generally produces bowel movement in 12-72 hours" ], "set_id": "a8f7554c-eae7-44fb-ac66-a7d678bcb91a", "id": "16a7177b-b651-4120-97f1-270295bcfa22", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient per 5 mL (1 teaspoon) Docusate Sodium 50 mg" ] }, { "effective_time": "20110406", "inactive_ingredient": [ "Inactive ingredients: hexamethyldisiloxane, hydroxypropylcellulose, isopropyl alcohol, oleyl alcohol, NF, propylene glycol, USP, vanilla fragrance." ], "contraindications": [ "Contraindication LidoWorx™ is contraindicated in patients with sensitivity to the amide type local anesthetics or to any other component of the product." ], "purpose": [ "Purpose: Topical anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away" ], "precautions": [ "Precautions General Repeated doses of LidoWorx™ may increase blood levels of lidocaine. Avoid contact with the eye since it may cause severe irritation and loss of protective reflexes. If eye contact occurs, immediately wash out the eye with water or saline. Patients with severe hepatic disease are at a greater risk of developing toxic plasma concentrations of lidocaine. Information for Patients When LidoWorx™ is used the patient should be aware that the production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing or exposure to extreme hot or cold temperatures until complete sensation has returned. Drug Interactions LidoWorx™ should be used with caution in patients receiving Class I antiarrythmic agents (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Metabolites of lidocaine have been shown to be carcinogenic in laboratory animals. A two-year oral toxicity study of 2,6-xylidine, a metabolite of lidocaine, has shown that in both male and female rats daily doses of 900 mg/m2 (60 times SDA) resulted in adenomas and carcinomas of the nasal cavity. With daily doses of 300 mg/m2 (20 times SDA) the increase in incidence of nasal carcinomas and or adenomas in each sex of the rat were not statistically greater than the control group. In the low dose (90 mg/m2, 6 times SDA) and control groups, no nasal tumors were observed. Mutagenesis The mutagenic potential of lidocaine HCl has been tested in the Ames Salmonella -mammalian microsome test and by analysis of structural chromosome aberrations in human lymphocites in vitro, and by the mouse micronuclear test in vivo. There was no indication in these three tests of any mutagenic effects. The mutagenicity of 2,6-xylidine, a metabolite of lidocaine has been studied in different tests with mixed results. The compound was found to be weakly mutagenic in the Ames test only under metabolic activation conditions. In addition, 2,6-xylidine was observed to be mutagenic at the thymidine kinase locus, with or without activation, and induced chromosome aberrations and sister chromatid exchanges at concentrations in which the drug precipitated out of solution (1.2 mg/ml). No evidence of genotoxicity was found in the in vivo assays measuring unscheduled DNA synthesis in rat hepatocytes, chromosome damage in polychromatic erythrocytes or preferential killing of DNA repair-deficient bacteria in liver, lung kidney, testes and blood extracts from mice. However covalent binding studies of DNA from liver and ethmoid turbinates in rats indicate that 2,6 xylidine may be genotoxic under certain conditions in vivo. Use in Pregnancy Teratogenic Effects: Pregnancy Category B Reproduction studies with lidocaine have been performed in rats and have revealed no evidence of harm to the fetus (30 mg/kg subcutaneously, 22 times SDA). There are however, no adequate and well-controlled studies on pregnant women. Therefore LidoWorx™ should be used in pregnancy only under a doctor's supervision. Labor and Delivery Lidocaine is not contraindicated in labor and delivery. Should LidoWorx™ be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered. Nursing Mothers Lidocaine is excreted in human milk, therefore, caution should be exercised when LidoWorx™ is administered to a nursing mother since the milk:plasma ratio of lidocaine is 0.4. Pediatric Use Consult a doctor. Observe child during application to avoid accidental ingestion. Not for otic or ophtalmic use." ], "warnings": [ "Warnings: For external use only. Flammable: Keep away from open fire or flame. When using this product avoid contact with eyes. do not use in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if the condition worsens or if the symptoms clear up and occur again in a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away", "Warning For external use only . Flammable: Keep away from open fire or flame. Caution - Do not use in the eyes. Not for prolonged use. If the condition for which this preparation is used persists or if a rash develops, discontinue use and consult physician. Avoid contact with the eyes. Do not use over large areas of the body. Do not use for more than 7 days unless directed by a doctor. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Inappropriate use of this product, such as application on mucous membranes, on large areas of the body or for long periods of time, or on individuals that are allergic to the amide type anesthetics, may result in serious side effects. Consultation with a doctor before using this product is strongly recommended." ], "when_using": [ "When using this product avoid contact with eyes. do not use in large quantities, particularly over raw surfaces or blistered areas" ], "spl_product_data_elements": [ "LidoWorx lidocaine LIDOCAINE LIDOCAINE Propylene Glycol Isopropyl Alcohol" ], "description": [ "Description LidoWorx™ incorporates DermWorx patented Small Molecule Solubilization System ™ (SMSS™) for a very rapid and optimum onset of anesthetic action. LidoWorx™ is an alcoholic, non-oily, translucent gel containing 4% lidocaine with skin permeation enhancers, indicated as a topical analgesic for use on normal intact skin for rapid local analgesia." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.", "Directions for Use Adults and children 2 years and older: Apply externally to the affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a doctor. Apply a moderately thick layer to the affected area (approximately 1/8 inch thick). Allow time, for numbness to develop, approximately 15 minutes. Best results are obtained 15 to 30 minutes post-application. Wipe-off excess gel. LidoWorx™ may be applied under an occlusive dressing." ], "pregnancy_or_breast_feeding": [ "Use in Pregnancy Teratogenic Effects: Pregnancy Category B Reproduction studies with lidocaine have been performed in rats and have revealed no evidence of harm to the fetus (30 mg/kg subcutaneously, 22 times SDA). There are however, no adequate and well-controlled studies on pregnant women. Therefore LidoWorx™ should be used in pregnancy only under a doctor's supervision. Labor and Delivery Lidocaine is not contraindicated in labor and delivery. Should LidoWorx™ be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered. Nursing Mothers Lidocaine is excreted in human milk, therefore, caution should be exercised when LidoWorx™ is administered to a nursing mother since the milk:plasma ratio of lidocaine is 0.4. Pediatric Use Consult a doctor. Observe child during application to avoid accidental ingestion. Not for otic or ophtalmic use." ], "adverse_reactions": [ "Adverse Reactions Localized Reactions During or immediately after treatment with LidoWorx™ the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. These effects are mild and transient, resolving spontaneously within 1 or 2 hours. Other common effects is paleness (pallor or blanching) when the application time is very prolonged (over 2 hours), and less frequently alterations in temperature sensations, edema, itching and rash. Allergic Reactions Allergic and anaphylactoid reactions associated with lidocaine can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock. Systemic (Dose Related) Reactions Systemic adverse reactions following appropriate use of LidoWorx™ are unlikely. Systemic adverse effects of lidocaine are similar in nature to those observed with other amide type local anesthetics including CNS excitation and/or depression (light-headedness; nervousness; apprehension; euphoria; confusion; dizziness; drowsiness; tinnitus; blurred or double vision; vomiting; sensations of heat, cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest). Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest." ], "stop_use": [ "Stop use and ask a doctor if the condition worsens or if the symptoms clear up and occur again in a few days" ], "spl_unclassified_section": [ "Other Information: Store at controlled room temperature15-30 °C.", "Patient Information LIDOWORX™ Gel (4% lidocaine) Topical Anesthetic for Local or Dermal Analgesia", "Composition Each gram of LidoWorx™ contains lidocaine (40 mg) in a gel composed of hexamethyldisiloxane, hydroxypropylcellulose, isopropyl alcohol, oleyl alcohol NF, propylene glycol USP, and vanilla fragrance. The chemical designation of lidocaine is 2-(diethylamino)-N(2,6-dimethylphenyl),acetamide; melting point 68-69°C; molecular weight 234.33. It has the following structure: Lidocaine Cheimcal Structure", "Mechanism of Action LidoWorx™ applied to intact skin provides dermal analgesia by the release of lidocaine from the gel into the epidermis and dermis. Lidocaine is a local anesthetic agent of the amide type. Local anesthetics reversibly block the initiation and conduction of nerve impulses by interfering with the flux of sodium ions though the neuronal membrane. The onset, depth and duration of dermal analgesia provided by LidoWorx™ depend primarily on the site of application and duration of application. Dermal analgesia is obtained within 30 minutes of application, and the effect persists for approximately 30 minutes after removal. Areas such as the upper lip may become numb after 15 minutes of application. Dermal application of LidoWorx™ may cause local blanching followed by local redness or erythema. These effects are mild and transitory.", "Pharmacokinetics LidoWorx™ is formulated to insure local penetration of lidocaine into the skin. A side effect of this desired local effect may be the systemic absorption of lidocaine. The systemic absorption of lidocaine from LidoWorx™ has not been determined in clinical studies, but information available in the literature indicates that the amount of lidocaine systemically absorbed is directly related to both the duration of application and to the area over which it is applied. By inference from published clinical studies, the application of LidoWorx™ to broken or inflamed skin, or to 2,000 cm 2 or more of skin of an adult, (600 cm 2 in children 10-20 kg body weight, 100 cm 2 in children up to 10 kg) could result in plasma levels that could, in susceptible individuals, produce a systemic pharmacologic response. Patients receiving lidocaine by prolonged infusion (for suppression of ventricular dysrhythmias) present objective systemic toxic effects at plasma concentrations of 6-10 µg/ml. When lidocaine is administered intravenously, it distributes to highly perfused organs such as brain, liver, kidney and heart. Lidocaine binds to plasma proteins (approx. 70%). It can cross the placental and blood brain barrier, presumably by passive diffusion. It is not known whether lidocaine is metabolized in the skin. When administered intravenously it is metabolized by the liver. The major metabolites are monoethylglycylxylidide (MEGX) and glycylxylidide (GX). The biological half-life of lidocaine is 1.5 hrs; its plasma clearance averages 1 L/min and is dependent on liver blood flow. Both MEGX and GX have pharmacologic effects, both as antiarrythmics and in terms of toxicity.", "Important Not for ophthalmic use Keep container closed at all times when not in use. Keep out of reach of children. Patch test recommended: As with any topical, it is recommended that a patch test be performed to rule out any untoward effects. Apply on a small, inconspicuous area and observe for 24 hours. Preferably repeat this patch test 7 days after the initial one.", "How Supplied LidoWorx™ 4% is supplied in the USA as a single use 0.4 oz (12 g) tube. Keep out of reach of children. This package is not child resistant, discard after initial use. Please note that the tubes are filled by weight, not volume. Air bubbles may be present in the gel. Store at controlled room temperature, 15-30 ˚C NDC # 28109-030-01 Distributed by: DermWorx, Inc. Hallandale, FL 33009 www.dermworx.com 1-877-dermworx" ], "package_label_principal_display_panel": [ "Principal Display Panel - Tube Label Our patented Small Molecule Solubilization System™ provides a very rapid and optimum onset of anesthetic action. Discard after Use. For External Use Only. Not for Ophthalmic Use. Keep Out of Reach of Children. DermWorx Incorporated Hallandale, FL 33009 www.dermworx.com 1-877-dermworx NDC 28109-030-01 LidoWorx™ Gel (4% lidocaine) FOR PROFESSIONAL USE ONLY Topical Anesthetic for local or dermal analgesia 0.4 oz (12 gm) Tube Label Principal Display Panel - Tube Label", "Principal Display Panel - Outer Carton Label NDC 28109-030-06 LidoWorx™ Gel (4% lidocaine) Patented Small Molecule Solubilization System™ (SMSS™) provides a very rapid and optimum onset of anesthetic action. FOR PROFESSIONAL USE ONLY Topical Anesthetic for local or dermal analgesia DermWorx Incorporated Hallandale, FL 33009 www.dermworx.com 1-877-dermworx Outer Carton Label Principal Display Panel - Outer Carton Label" ], "indications_and_usage": [ "Use: For the temporary relief of pain and itching on normal intact skin.", "Indications and Usage LidoWorx™ (4% lidocaine) is indicated for the temporary relief of pain and itching. It is a topical analgesic for penetrating local pain relief on normal intact skin. LidoWorx™ is not recommended for use on mucous membranes because of much greater absorption than through intact skin. LidoWorx™ is not recommended for use beyond the external ear. Not for ophthalmic use." ], "set_id": "acb12230-7588-4960-919f-0e4caf597dac", "id": "f4e94f1a-e729-4802-8407-aea7d40eb7f9", "active_ingredient": [ "Active Ingredient: Lidocaine (4%)" ] }, { "effective_time": "20150817", "inactive_ingredient": [ "Inactive ingredients cocos nucifera (coconut) oil, olea europaea (olive) fruit oil, beeswax, euphorbia cerifera (candelilla) wax, simmondsia (chinensis) jojoba seed oil, carthamus tinctorius (safflower) seed oil, flavor, helianthus annuus (sunflower) seed oil, mangifera indica (mango) seed butter, ricinus communis (castor) seed oil, copernica cerifera (camauba) wax, jojoba esters, polyhydroxystearic acid, tocopherol [vitamin E], vanilla planifolia fruit extract, carmine, iron oxides, mica, titanium dioxide" ], "purpose": [ "Purpose Zinc oxide - Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Stop use and ask a doctor if • rash or irritation develops and lasts Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com" ], "spl_product_data_elements": [ "Softlips Pure Tint Coral Zinc oxide ZINC OXIDE ZINC OXIDE WHITE WAX" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply liberally before sun exposure and as needed • children under 6 months of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if • rash or irritation develops and lasts" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Softlips PURE coral charm sheer lip tint/conditioner color inspired by nature 100% natural Distributed by: The Mentholatum Company Orchard Park, NY 14127 Softlips PURE coral charm sheer lip tint/conditioner color inspired by nature 100% natural" ], "indications_and_usage": [ "Uses • helps prevent sunburn • provides UVA and UVB protection" ], "set_id": "ae90baa2-4f8b-46a6-b71b-9b323f990324", "id": "814887c8-8e5f-41de-8f3a-0c274581b38a", "active_ingredient": [ "Active ingredient Zinc oxide 6.5%" ] }, { "effective_time": "20110119", "inactive_ingredient": [ "Inactive Ingredients Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." ], "when_using": [ "When using this product Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "SnowSkin GolfersSkin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL LANOLIN .ALPHA.-TOCOPHEROL ACETATE, DL- VANILLA" ], "description": [ "Golfers Skin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera To report a serious adverse event, contact 1-800-332-1088 Expires: Lot Number: www.golfersskin.co DIST. BY Quiver Dist, Bend Oregon, USA 97701 AS/ANZ STANDARD 2604-1998 Tested on Golfers - Not Animals Net Wt. .3oz (8.5g)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Apply generously 15 mins before sun exposure and as needed Children under 6 months of age; ask a doctor Reapply as needed or after towel drying, swimming or sweating." ], "stop_use": [ "Stop use and ask a doctor if irritation occurs or rash develops ad lasts." ], "package_label_principal_display_panel": [ "SPF 30+ very water / sweat resistant broad spectrum UVA/UVB protection Proven in extreme New Zealand conditions Golfers Skin sunscreen lip balm Net Wt. .30 oz (8.5g) contains no nanoparticles - aminobenzoic acid (PABA)-free", "Golfers Skin Lip Balm", "Golfer Skin Sunscreen" ], "indications_and_usage": [ "Uses Helps prevent sunburn Higher SPF gives more sunburn protection Provides high protection against sunburn Regains SPF after 80 minutes of sweating." ], "set_id": "afc9657f-9e43-4ba0-bbf0-8e0a25979196", "id": "7926f0d8-c953-4fc8-9c3c-a470ffda8dc4", "active_ingredient": [ "Active Ingredients Avobenzone 2.5% Octinoxate 7.5% Octocrylene 5.0%" ] }, { "effective_time": "20140926", "inactive_ingredient": [ "Ingredients *Aloe Barbadensis ( Aloe ) Leaf Juice, *Helianthus Annuus ( Sunflower ) Oil, Carthamus Tinctorius ( Safflower ) Oleosomes, *Sucrose Cocoate (from Coconut ), Water, *Citrus Aurantium Dulcis ( Sweet Orange ) Essential Oil, Microcrystalline Cellulose, Citric Acid (from Non-GMO Corn ), Leuconostoc Ferment Filtrate (from Radish ), *Glycerin (from Sustainable Palm ), *Citrus Tangerina ( Tangerine ) Essential Oil, *Aloe Barbadensis ( Aloe ) Extract, Tocopherol ( Sunflower Vitamin E ), Gluconolactone (from Non-GMO Corn ), *Vanilla Planifolia ( Vanilla ) CO 2 Extract, Xanthan Gum, *Lecithin (from Soybean ), Cellulose Gum. *=Certified Organic" ], "instructions_for_use": [ "Directions: Directions: • For full protection, apply liberally (2 mg/cm2 of skin) 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating Reapply: • At least every 2 hours Sun Protection Measures • Spending time in the sun increases your risk of skin cancer and early skin aging • To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 am - 2 pm • Wear long sleeved shirts, pants, hats, and sunglasses • For children under 6 months: ask a doctor." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only" ], "when_using": [ "When using this product When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Badger Kids SPF 30 Sunscreen Zinc Oxide ZINC OXIDE ZINC OXIDE WATER SUNFLOWER OIL CARTHAMUS TINCTORIUS SEED OLEOSOMES SUCROSE COCOATE ORANGE OIL CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE MANDARIN OIL ALOE VERA LEAF GLYCERIN TOCOPHEROL GLUCONOLACTONE VANILLA XANTHAN GUM LECITHIN, SOYBEAN CARBOXYMETHYLCELLULOSE SODIUM" ], "warnings_and_cautions": [ "Active Ingredient Non-Nano Uncoated Zinc Oxide 12%" ], "other_safety_information": [ "Other Information: Store at temperatures below 90°F." ], "openfda": {}, "version": "2", "do_not_use": [ "Do not use Do not use on damaged or broken skin. Stop and ask a doctor if rash occurs." ], "package_label_principal_display_panel": [ "Principal Display Panel Image Components image description" ], "indications_and_usage": [ "Uses: • Helps prevent sunburn • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "b2361976-e1aa-4545-8e27-9ed986c1ffdf", "id": "7758820e-3a7b-4d11-806d-a30945693663" }, { "effective_time": "20140207", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER, SODIUM LAURETH SULFATE, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYLAMINE OXIDE, PPG-1-PEG-9 LAURYL GLYCOL ETHER, FRAGRANCE (PARFUM), PEG-7 GLYCERYL COCOATE, BENZOPHENONE-4, GLYCERIN, TETRASODIUM EDTA, SODIUM CHLORIDE, BENZYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, VANILLA PLANIFOLIA FRUIT EXTRACT, PROPYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)" ], "purpose": [ "PURPOSE ANTIBACTERIAL" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USING THIS PRODUCT AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USING THIS PRODUCT AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "CAREONE VANILLA BROWN SUGAR TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE DISODIUM LAURETH SULFOSUCCINATE COCAMIDOPROPYLAMINE OXIDE PEG-7 GLYCERYL COCOATE SULISOBENZONE GLYCERIN EDETATE SODIUM SODIUM CHLORIDE BENZYL ALCOHOL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) GREEN TEA LEAF ALOE VERA LEAF VANILLA PROPYLENE GLYCOL HYPROMELLOSES CITRIC ACID ACETATE SODIUM HYDROXIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY TO DRY HANDS, WORK INTO A RICH FOAMY LATHER AND RINSE THOROUGHLY" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES FOR WASHIG TO DECREASE BACTERIA ON THE SKIN" ], "set_id": "b45218c2-9a56-4541-9bb2-a554dc5a3ace", "id": "15148e63-976e-4eb4-835f-bdfb96036d44", "active_ingredient": [ "ACTIVE INGREDIENT TRICLOSAN 0.46% PURPOSE ANTIBACTERIAL" ] }, { "effective_time": "20110103", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE, VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200)." ], "purpose": [ "PURPOSE ANTISEPTIC" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS. KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER." ], "questions": [ "QUESTIONS OR COMMENTS 1-866-695-3030" ], "spl_product_data_elements": [ "VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL GLYCERIN ISOPROPYL MYRISTATE AMINOMETHYLPROPANOL CARBOMER 934 .ALPHA.-TOCOPHEROL ACETATE, D- VANILLA APPLE ALOE VERA LEAF MANNITOL POWDERED CELLULOSE HYPROMELLOSES FERRIC OXIDE RED D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT A TEMPERATURE BELOW 110 0 F (43 0 C)." ], "package_label_principal_display_panel": [ "PACKAGE FRONT AND BACK LABELS IMAGE OF VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER 2 FL OZ" ], "indications_and_usage": [ "USES TO HELP REDUCE BACTERIA ON THE SKIN." ], "set_id": "b52566cb-2314-4131-9663-bc20950cabec", "id": "698e3c0d-b760-4ec7-9631-65c2c47fb097", "active_ingredient": [ "ACTIVE INGREDIENT ETHYL ALCOHOL 62 PERCENT" ] }, { "effective_time": "20120807", "inactive_ingredient": [ "Inactive ingredients (Cherry Blossom) Aloe Barbadensis Leaf Juice, Benzophenone-4, Cocamide DEA, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.", "Inactive ingredients (Ocean Breeze) Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Cocamide DEA, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua).", "Inactive ingredients (Warm Vanilla Sugar) Aloe Barbadensis Leaf Juice, Benzophenone-4, Cocamide DEA, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.", "Inactive ingredients (Dark Raspberry) Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.", "Inactive ingredients (Red Pomegranate) Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1,Cocamide DEA, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.", "Inactive ingredients (Autumn Orange) Aloe Barbadensis Leaf Juice, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.", "Inactive ingredients (Enchanted Woods) Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua)." ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation and redness develop. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "questions": [ "QUESTIONS? 1-800-FDA-1088" ], "spl_product_data_elements": [ "Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions wet hands, work into rich lather rinse well" ], "stop_use": [ "Stop use and ask a doctor if irritation and redness develop." ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® CHERRY BLOSSOM anti-bacterial foaming hand soap 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® OCEAN BREEZE anti-bacterial foaming hand soap 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® WARM VANILLA SUGAR anti-bacterial foaming hand soap 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® DARK RASPBERRY anti-bacterial foaming hand soap 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® RED POMEGRANATE anti-bacterial foaming hand soap 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® limited edition autumn orange anti-bacterial foaming hand soap 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® limited edition enchanted woods anti-bacterial foaming hand soap 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label" ], "indications_and_usage": [ "Use handwashing to decrease bacteria on skin" ], "set_id": "b6057e65-e3dd-4996-900b-33ad600ccfe8", "id": "b6057e65-e3dd-4996-900b-33ad600ccfe8", "active_ingredient": [ "Active ingredient Triclosan 0.3%" ] }, { "effective_time": "20130611", "inactive_ingredient": [ "Inactive Ingredients Actilastin 1000, Melaleuca Alternifolia, Eucalyptus Polybractea, Citronella, Leptospermum Petersonii, Vanilla" ], "purpose": [ "Purpose Sunscreen 30+" ], "keep_out_of_reach_of_children": [ "Keep out of Reach of Children Keep Out of Reach of Children" ], "warnings": [ "Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center right away. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF or 15 or higher and other sun protection measures including: limit time in the sun, especially between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. children under 6 months: Ask a doctor." ], "spl_product_data_elements": [ "Outback Series 2-in-1 Sunscreen Octyl Methoxycinnamate,Avobenzone and Zinc Oxide OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE Zinc Oxide Zinc Oxide EUCALYPTUS POLYBRACTEA LEAF OIL LEPTOSPERMUM PETERSONII LEAF OIL CITRONELLA OIL TEA TREE OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and Administration Apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours." ], "package_label_principal_display_panel": [ "Product Label obc 1 lab obc 2 lab" ], "indications_and_usage": [ "Indication and Usage Helps prevent sunburn. if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "b7453351-ac07-443a-bea9-e1cd8dc2ca9b", "id": "28745142-046e-4552-bd9b-1653fbb1a647", "active_ingredient": [ "Active ingrdient Octyl Methoxycinnamate - 7.5% Avobenzone - 1.3% Zinc Oxide - 9.5%" ] }, { "effective_time": "20120920", "inactive_ingredient": [ "Inactive Ingredients Olive Oil (INCI name: Olea Europaea (Olive) Vanilla (INCI Name: Vanillin)" ], "purpose": [ "Purpose Massage Oil to assist with relief of joint and muscle pain" ], "keep_out_of_reach_of_children": [ "Keep out of Reach of Children Keep Out of Reach of Children" ], "warnings": [ "Warnings For external use only. In case of accidental ingestion, get medical help or contact a Poisons Control Center right away." ], "spl_product_data_elements": [ "Out Back Pain Relief Tea Tree OIl and Eucalyptus Oil TEA TREE OIL Tea Tree Oil EUCALYPTUS OIL EUCALYPTUS OIL Olive Oil" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and Administration Apply a small amount of Out Back Pain Relief Oil to the pain affected area and gently massage in until fully absorbed. Use before and after activity for maximum relief." ], "package_label_principal_display_panel": [ "Product Label Sachet Bottle" ], "indications_and_usage": [ "Indication and Usage Temporary relief of joint and muscle pain, including lower back pain" ], "set_id": "c0264e4c-2224-403e-8fd7-b796bb598375", "id": "5109c9ab-837e-4705-ac81-83a552023a11", "active_ingredient": [ "Active Ingredients Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml) Eucalyptus Oil (E. Polybractea) - 3.86% (38.6 mg/ml)" ] }, { "effective_time": "20100802", "inactive_ingredient": [ "Inactive Ingredients Warm Vanilla Sugar Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5 Sweet Cherry Blossom Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Fresh Ocean Breeze Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5 Cool Cucumber Melon Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5 Irresistible Green Apple Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Yellow 5 Alluring Red Pomegranate Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 40, Red 33, Blue 1 Sparkling White Cranberry Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5", "Questions? 1-800-FDA-1088" ], "purpose": [ "Purpose Antibacterial" ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation and redness develop. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Antibacterial Hand Soap Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE SODIUM CHLORIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Hand Soap Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE SODIUM CHLORIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Hand Soap Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE SODIUM CHLORIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Hand Soap Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE SODIUM CHLORIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Antibacterial Hand Soap Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE SODIUM CHLORIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Antibacterial Hand Soap Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE SODIUM CHLORIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE FD&C RED NO. 40 D&C RED NO. 33 FD&C BLUE NO. 1 Antibacterial Hand Soap Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE SODIUM CHLORIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions wet hands, work into rich lather rinse well" ], "spl_unclassified_section": [ "SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For Shopko Stores Operating Co., LLC Green Bay, WI 54307, U.S.A. ©2010 Shopko Stores Operating Co., LLC" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Warm VANILLA SUGAR antibacterial hand soap PARABEN FREE contains aloe vera and vitamins A & E 11.2 fl oz Warm Vanilla Sugar Bottle Label Warm Vanilla Sugar Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Sweet CHERRY BLOSSOM antibacterial hand soap PARABEN FREE contains aloe vera and vitamins A & E 11.2 fl oz Sweet Cherry Blossom Bottle Label Sweet Cherry Blossom Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Fresh OCEAN BREEZE antibacterial hand soap PARABEN FREE contains aloe vera and vitamins A & E 11.2 fl oz Fresh Ocean Breeze Bottle Label Fresh Ocean Breeze Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Cool CUCUMBER MELON antibacterial hand soap PARABEN FREE contains aloe vera and vitamins A & E 11.2 fl oz Cool Cucumber Melon Bottle Label Cool Cucumber Melon Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Irresistible GREEN APPLE antibacterial hand soap PARABEN FREE contains aloe vera and vitamins A & E 11.2 fl oz Irresistible Green Apple Bottle Label Irresistible Green Apple Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Alluring RED POMEGRANATE antibacterial hand soap PARABEN FREE contains aloe vera and vitamins A & E 11.2 fl oz Alluring Red Pomegranate Bottle Label Alluring Red Pomegranate Bottle Label", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Sparkling WHITE CRANBERRY antibacterial hand soap PARABEN FREE contains aloe vera and vitamins A & E 11.2 fl oz Sparkling White Cranberry Bottle Label Sparkling White Cranberry Bottle Label" ], "indications_and_usage": [ "Uses handwashing to decrease bacteria on skin" ], "set_id": "c089e2c4-d768-432a-8fdc-85d37a7d316e", "id": "c089e2c4-d768-432a-8fdc-85d37a7d316e", "active_ingredient": [ "Active ingredient Triclosan 0.3%" ] }, { "effective_time": "20130308", "inactive_ingredient": [ "​Inactive Ingredients: ​ ​ Water/Eau, Butylene Glycol, Glycerin, PEG-8, Dimethicone, Nylon-12, Citrus Medica Limonum (Lemon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Fumaria Officinalis Flower/Leaf/Stem Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Vanilla Planifolia Fruit Extract, Theobroma Cacao (Cocoa) Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Vitis Vinifera (Grape) Fruit Extract, Tromethamine, Silica, Trimethylsiloxysilicate, Glyceryl Stearate, Hydrogenated Lecithin, Carbomer, Polyglyceryl-3 Diisostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Squalane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Fumaric Acid, Citric Acid, Disodium EDTA, Benzyl Alcohol, Cetyl Alcohol, Polysorbate 60, Methylparaben, Propylparaben" ], "purpose": [ "​ Purpose ​ ​...........Sunscreen ...........Sunscreen ...........Sunscreen ...........Sunscreen ...........Sunscreen" ], "keep_out_of_reach_of_children": [ "​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "​Warnings ​For external use only ​Do not use ​on damaged or broken skin ​When using this product ​ keep out of eyes. Rinse with water to remove. ​Stop use and ask a doctor if ​rash occurs ​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "​When using this product ​ keep out of eyes. Rinse with water to remove." ], "questions": [ "​Questions or Comments? ​ ​Call toll free ​1-800-meetmark" ], "spl_product_data_elements": [ "mark. For Gooness Face Antioxidant Skin Moisturizing Homosalate, Octinoxate, Octisalate, Oxybenzone, Avobenzone HOMOSALATE HOMOSALATE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE AVOBENZONE AVOBENZONE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "​Directions ​ ​apply liberally 15 minutes before sun exposure children under 6 months of age: ask a doctor reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating ​Sun Protection Measures. ​Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses" ], "stop_use": [ "​Stop use and ask a doctor if ​rash occurs ​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away." ], "storage_and_handling": [ "​Other information ​ ​protect the product in this container from excessive heat and direct sun" ], "do_not_use": [ "​Do not use ​on damaged or broken skin ​When using this product ​ keep out of eyes. Rinse with water to remove. ​Stop use and ask a doctor if ​rash occurs ​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away." ], "package_label_principal_display_panel": [ "image of carton image of carton image of carton" ], "indications_and_usage": [ "​Uses ​ ​helps prevent sunburn if used as directed with other sun protection measures (see Directions) , decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "c13846a9-3af3-41aa-9185-c5e0bfbc2fe8", "id": "3bb52643-1d5c-423f-8b4f-b7409f7443b3", "active_ingredient": [ "​Active Ingredients ​ ​Homosalate 8.0%......... Octinoxate 7.5%........... Octisalate 5.0%............ Oxybenzone 5.0%.......... Avobenzone 3.0%.......... ​ Purpose ​ ​...........Sunscreen ...........Sunscreen ...........Sunscreen ...........Sunscreen ...........Sunscreen" ] }, { "effective_time": "20110119", "inactive_ingredient": [ "Inactive Ingredients Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." ], "when_using": [ "When using this product Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "GolfersSkin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL LANOLIN .ALPHA.-TOCOPHEROL ACETATE, DL- VANILLA" ], "description": [ "Golfers Skin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera To report a serious adverse event, contact 1-800-332-1088 Expires: Lot Number: www.golfersskin.co DIST. BY Quiver Dist, Bend Oregon, USA 97701 AS/ANZ STANDARD 2604-1998 Tested on Golfers - Not Animals Net Wt. .3oz (8.5g)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply generously 15 mins before sun exposure and as needed Children under 6 months of age; ask a doctor Reapply as needed or after towel drying, swimming or sweating." ], "stop_use": [ "Stop use and ask a doctor if irritation occurs or rash develops and lasts." ], "package_label_principal_display_panel": [ "SPF 30+ very water / sweat resistant broad spectrum UVA/UVB protection Proven in extreme New Zealand conditions Golfers Skin sunscreen lip balm Net Wt. .30 oz (8.5g) contains no nanoparticles - aminobenzoic acid (PABA)-free", "Golfers Skin Lip Balm", "Golfer Skin Sunscreen" ], "indications_and_usage": [ "Uses Helps prevent sunburn Higher SPF gives more sunburn protection Provides high protection against sunburn Retains SPF after 80 minutes of sweating." ], "set_id": "c77eee09-8591-47c9-8763-7a7a82503f20", "id": "6fa34154-3763-4ee4-89c0-49bea4fd9b7e", "active_ingredient": [ "Active Ingredients Avobenzone 2.5% Octinoxate 7.5% Octocrylene 5.0%" ] }, { "effective_time": "20120511", "inactive_ingredient": [ "Inactive ingredients (cinnamon pumpkin spice) Aloe Barbadensis Leaf Juice, Aqua, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Yellow 5", "Inactive ingredients (vanilla scream) Aloe Barbadensis Leaf Juice, Aqua, Benzophenone-4, Blue-1, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Yellow 5" ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation and redness develop. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "questions": [ "QUESTIONS? 1-800-FDA-1088" ], "spl_product_data_elements": [ "Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE PROPYLENE GLYCOL DMDM HYDANTOIN ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE ACETYL TRIETHYLHEXYL CITRATE EDETATE DISODIUM SULISOBENZONE .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions wet hands, work into rich lather rinse well" ], "stop_use": [ "Stop use and ask a doctor if irritation and redness develop." ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® cinnamon pumpkin spice ANTI-BACTERIAL FOAMING HAND SOAP 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® vanilla scream ANTI-BACTERIAL FOAMING HAND SOAP 10.1 fl.oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Bottle Label Bottle Label" ], "indications_and_usage": [ "Use handwashing to decrease bacteria on skin" ], "set_id": "ce8fcd75-1c90-4c29-a1cb-2f81551c8bd3", "id": "ce8fcd75-1c90-4c29-a1cb-2f81551c8bd3", "active_ingredient": [ "Active ingredient Triclosan 0.3%" ] }, { "effective_time": "20130418", "inactive_ingredient": [ "Inactive Ingredients Olive Oil (INCI name: Olea Europaea (Olive) Vanilla (INCI Name: Vanillin)" ], "purpose": [ "Purpose Massage Oil to assist with relief of joint and muscle pain" ], "keep_out_of_reach_of_children": [ "Keep out of Reach of Children Keep Out of Reach of Children" ], "warnings": [ "Warnings For external use only. In case of accidental ingestion, get medical help or contact a Poisons Control Center right away." ], "spl_product_data_elements": [ "Elmore Oil Tea Tree OIl and Eucalyptus Oil TEA TREE OIL Tea Tree Oil EUCALYPTUS OIL EUCALYPTUS OIL Olive Oil" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and Administration Apply a small amount of Elmore Oil to the pain affected area and gently massage in until fully absorbed. Use before and after activity for maximum relief." ], "package_label_principal_display_panel": [ "Product Label 50 ml label 250 ml label" ], "indications_and_usage": [ "Indication and Usage Temporary relief of joint and muscle pain, including lower back pain" ], "set_id": "ce9344f9-a4bd-4815-b47f-28ce222f1b87", "id": "20ccb5e0-2227-408e-b1ad-6e62ba1dc3de", "active_ingredient": [ "Active Ingredients Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml) Eucalyptus Oil (E. Polybractea) - 3.86% (38.6 mg/ml)" ] }, { "effective_time": "20120628", "inactive_ingredient": [ "Inactive ingredients (Frosted Vanilla) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Blue 1, Cellulose, Fragrance (Parfume), Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Water (Aqua), Yellow 5", "Inactive ingredients (Merry Berry) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Cellulose, Fragrance (Parfume), Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Water (Aqua)", "Inactive ingredients (Winter Gumdrop) Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Blue 1, Cellulose, Fragrance (Parfume), Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Water (Aqua), Yellow 5" ], "purpose": [ "Purpose Anti-bacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Flammable, keep away from fire or flame. Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. If contact occurs, rinse thoroughly with water. Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor." ], "questions": [ "QUESTIONS? 1-800-FDA-1088" ], "spl_product_data_elements": [ "Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C RED NO. 40 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C YELLOW NO. 5 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply to hands until thoroughly wet. Rub vigorously until dry. Supervise children in the use of this product." ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Frosted Vanilla anti-bacterial hand gel 1 fl. oz. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Merry Berry anti-bacterial hand gel 1 fl. oz. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Bottle Label Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL bath·body·etc ® Winter Gumdrop anti-bacterial hand gel 1 fl. oz. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in China Distributed by Jets, Sets & Elephants Beauty Corp, For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2012 ShopKo Stores Operating Co., LLC Bottle Label Bottle Label" ], "indications_and_usage": [ "Use To decrease bacteria on the skin and clean hands. Recommended for repeated use." ], "set_id": "d0004ee4-2da6-4750-bbd1-ca952444dcf7", "id": "d0004ee4-2da6-4750-bbd1-ca952444dcf7", "active_ingredient": [ "Active Ingredient Ethyl Alcohol 62% w/w" ] }, { "effective_time": "20140303", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), FRAGRANCE (PARFUM), PROPYLENE GLYCOL, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAMELLIA SINENSIS LEAF EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)" ], "purpose": [ "PURPOSE ANTISEPTIC" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "questions": [ "QUESTIONS/COMMENTS? 1-866-695-3030" ], "spl_product_data_elements": [ "ORCHID BY H E B VANILLA BROWN SUGAR ETHYL ALCOHOL ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL CARBOMER 934 GLYCERIN AMINOMETHYLPROPANOL MANNITOL POWDERED CELLULOSE HYPROMELLOSES ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES GREEN TEA LEAF VANILLA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE FD&C YELLOW NO. 5 D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "storage_and_handling": [ "OTHER INFORMATION STORE AT A TEMPERATURE BELOW 110°F (43°C)" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE BACTERIA ON THE SKIN" ], "set_id": "d0ef52a5-312f-4d26-9137-7d2dc45ab4c2", "id": "706297f9-9ab3-4ef1-ab50-5bcf901c3ba0", "active_ingredient": [ "ACTIVE INGREDIENT ETHYL ALCOHOL 65% PURPOSE ANTISEPTIC" ] }, { "effective_time": "20101223", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER, AMMONIUM LAURYL SULFATE, ACRYLATES COPOLYMER, COCAMIDOPROPYL BETAINE, GLYCOL DISTEARATE, GLYCERIN, SODIUM CHLORIDE, GYCERETH-26, COCO-GLUCOSIDE, GLYCERYL OLEATE, LAURYL LACTYL LACTATE, GLYCERYL STERATE, VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, TOCOPHERYL ACETATE, BENZOPHENONE-4, DISODIUM EDTA, SODIUM HYDROXIDE, CITRIC ACID, BENZYL ALCOHOL, FRAGRANCE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE." ], "purpose": [ "PURPOSE ANTIBACTERIAL" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS OR LASTS." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER." ], "questions": [ "QUESTIONS OR COMMENTS 1-866-695-3030" ], "spl_product_data_elements": [ "VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL MOISTURIZING HAND SP TRICLOSAN TRICLOSAN TRICLOSAN WATER AMMONIUM LAURYL SULFATE CARBOMER COPOLYMER TYPE A COCAMIDOPROPYL BETAINE GLYCOL DISTEARATE GLYCERIN SODIUM CHLORIDE GLYCERETH-26 COCO GLUCOSIDE GLYCERYL MONOOLEATE LAURYL LACTATE GLYCERYL MONOSTEARATE VANILLA APPLE .ALPHA.-TOCOPHEROL ACETATE, D- SULISOBENZONE EDETATE DISODIUM SODIUM HYDROXIDE ANHYDROUS CITRIC ACID BENZYL ALCOHOL MANNITOL POWDERED CELLULOSE HYPROMELLOSES FERRIC OXIDE RED D&C RED NO. 33 METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY TO WET HANDS, LATHER AND RINSE THOROUGHLY." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS OR LASTS." ], "package_label_principal_display_panel": [ "IMAGE OF VANILLA CREAM AND APPLE BLOSSOM HAND SANITIZER" ], "indications_and_usage": [ "USES To help reduce bacteria on the skin." ], "set_id": "d2a72a58-089d-42f2-94bf-1c4c455054af", "id": "75602309-5bed-446b-b538-ad42e279a993", "active_ingredient": [ "ACTIVE INGREDIENT TRICLOSAN 0.3 PERCENT" ] }, { "effective_time": "20110117", "inactive_ingredient": [ "Inactive Ingredients Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." ], "when_using": [ "When using this product Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Surfers Skin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF YELLOW WAX AVOCADO OIL YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL LANOLIN .ALPHA.-TOCOPHEROL ACETATE, DL- VANILLA" ], "description": [ "Surfers Skin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera To report a serious adverse event, contact 1-800-332-1088 Expires: Lot Number: www.surfersskin.co DIST. BY Quiver Dist, Bend Oregon, USA 97701 AS/ANZ STANDARD 2604-1998 Tested on Sursfers - Not Animals Net Wt. .3oz (8.5g)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply generously 15 mins before sun exposure and as needed Children under 6 months of age; ask a doctor Reapply as needed or after towel drying, swimming or sweating." ], "stop_use": [ "Stop use and ask a doctor if irritation occurs or rash develops ad lasts." ], "package_label_principal_display_panel": [ "SPF 30+ very water / sweat resistant broad spectrum UVA/UVB protection Proven in extreme New Zealand conditions Surfers Skin sunscreen lip balm Net Wt. .30 oz (8.5g) contains no nanoparticles - aminobenzoic acid (PABA)-free", "Surfers Skin Lip Balm", "Surfer Skin Sunscreen" ], "indications_and_usage": [ "Uses Helps prevent sunburn Higher SPF gives more sunburn protection Provides high protection against sunburn Regains SPF after 80 minutes of sweating." ], "set_id": "d49062c4-90b1-4db5-b616-1971fa628346", "id": "6d887782-a098-40f7-b9b0-419be858a36a", "active_ingredient": [ "Active Ingredients Avobenzone 2.5% Octinoxate 7.5% Octocrylene 5.0%" ] }, { "effective_time": "20131016", "inactive_ingredient": [ "Inactive Ingredients: Deionized water Fructose Natural Cherry flavor Vanilla flavor Natural color Citric acid Potassium Benzoate Xanthan gum" ], "purpose": [ "Homeopathic cough syrup for kids and teens" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "In case of overdose get medical help or contact poison control center right away A persistent cough may be a sign of a serious condition If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician Do not give this product for persistent or chronic cough associate with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician As with any medicine, if you are pregnant, may become pregnant, or breasfeeding, seek the advice of a health care professional before using this product" ], "spl_product_data_elements": [ "Wellness4Cough Syrup Cough Syrup Althaea officinalis, Prunus virginiana, Inula helenium ALTHAEA OFFICINALIS ROOT ALTHAEA OFFICINALIS ROOT PRUNUS VIRGINIANA BARK PRUNUS VIRGINIANA BARK INULA HELENIUM ROOT INULA HELENIUM ROOT MARRUBIUM VULGARE MARRUBIUM VULGARE EUCALYPTUS GLOBULUS LEAF EUCALYPTUS GLOBULUS LEAF RUMEX CRISPUS ROOT RUMEX CRISPUS ROOT SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT BRYONIA ALBA WHOLE BRYONIA ALBA WHOLE CAUSTICUM CAUSTICUM STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PHOSPHORUS PHOSPHORUS PULSATILLA VULGARIS PULSATILLA VULGARIS WATER FRUCTOSE CHERRY JUICE VANILLA NATURAL RED 26 CITRIC ACID MONOHYDRATE POTASSIUM BENZOATE XANTHAN GUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Adults and children 12 years of age and older: Take 2 teaspoons every 4 hours Or as needed Children 2 - 12 years of age: Take 1 teaspoon every 4 hours Or as needed Children under 2: Consult a physician for use" ], "package_label_principal_display_panel": [ "Wellness4 bottle label image image of label" ], "indications_and_usage": [ "For the temporary relief of coughs and congestion due to cold and flu. Helps loosen mucus (expectorant) and clear bronchial congestion. Soothes sore throat. For best Results: Keep mouth free of food and strong tastes for 15 minutes before and after taking. Hold liquid in mouth for 10-15 seconds before swallowing." ], "set_id": "da1463c8-8805-4fbc-88f2-210caead8ea3", "id": "40127dad-a783-4e4a-a5ce-042c8ea6aafb", "active_ingredient": [ "Active Ingredients: Althaea officinalis 1x Prunus virginiana 1x Inula helenium 3x Marrubium vulgare 3x Eucalyptus globulus 6x Rumex crispus 6x Sanguinaria canadensis 6x Bryonia alba 12x Causticum 12x Nux vomica 12x Phosphorus 12x Pulsatilla nigricans 12x" ] }, { "effective_time": "20120628", "inactive_ingredient": [ "Inactive Ingredients Ocean Breeze Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Retinyl Palmitate, Red 33, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua). Cherry Blossom Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5. Warm Vanilla Sugar Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5. Dark Raspberry Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5. Red Pomegranate Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.", "Questions? 1-800-FDA-1088" ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only." ], "when_using": [ "When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Shopko Antibacterial Deep Cleansing Hand Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE POLYSORBATE 20 SODIUM CHLORIDE SILICON DIOXIDE PEG-150 DISTEARATE DMDM HYDANTOIN LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE, D- ULTRAMARINE BLUE ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE SODIUM HYDROXIDE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE VITAMIN A PALMITATE FD&C BLUE NO. 1 D&C RED NO. 33 Shopko Antibacterial Deep Cleansing Hand Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE POLYSORBATE 20 SODIUM CHLORIDE SILICON DIOXIDE PEG-150 DISTEARATE DMDM HYDANTOIN LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE, D- ULTRAMARINE BLUE ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE SODIUM HYDROXIDE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Shopko Antibacterial Deep Cleansing Hand Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE POLYSORBATE 20 SODIUM CHLORIDE SILICON DIOXIDE PEG-150 DISTEARATE DMDM HYDANTOIN LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE, D- ULTRAMARINE BLUE ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE SODIUM HYDROXIDE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5 Shopko Antibacterial Deep Cleansing Hand Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE POLYSORBATE 20 SODIUM CHLORIDE SILICON DIOXIDE PEG-150 DISTEARATE DMDM HYDANTOIN LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE, D- ULTRAMARINE BLUE ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE SODIUM HYDROXIDE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE VITAMIN A PALMITATE FD&C BLUE NO. 1 D&C RED NO. 33 FD&C YELLOW NO. 5 Shopko Antibacterial Deep Cleansing Hand Triclosan TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE COCO DIETHANOLAMIDE POLYSORBATE 20 SODIUM CHLORIDE SILICON DIOXIDE PEG-150 DISTEARATE DMDM HYDANTOIN LACTOSE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE, D- ULTRAMARINE BLUE ALOE VERA LEAF METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE SODIUM HYDROXIDE EDETATE CALCIUM DISODIUM ANHYDROUS SULISOBENZONE VITAMIN A PALMITATE D&C RED NO. 33 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions wet hands, work into rich lather rinse well" ], "stop_use": [ "Stop use and ask a doctor If irritation and redness develop." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Ocean Breeze antibacterial deep cleansing hand soap 10.1 fl oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For Shopko Stores Operating Co., LLC Green Bay, WI 54307, U.S.A. ©2012 Shopko Stores Operating Co., LLC Ocean Breeze Bottle Label Principal Display Panel - Ocean Breeze", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Cherry Blossom antibacterial deep cleansing hand soap 10.1 fl oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For Shopko Stores Operating Co., LLC Green Bay, WI 54307, U.S.A. ©2012 Shopko Stores Operating Co., LLC Cherry Blossom Bottle Label Principal Display Panel - Cherry Blossom", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Warm Vanilla Sugar antibacterial deep cleansing hand soap 10.1 fl oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For Shopko Stores Operating Co., LLC Green Bay, WI 54307, U.S.A. ©2012 Shopko Stores Operating Co., LLC Warm Vanilla Sugar Bottle Label Principal Display Panel - Warm Vanilla Sugar", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Dark Raspberry antibacterial deep cleansing hand soap 10.1 fl oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For Shopko Stores Operating Co., LLC Green Bay, WI 54307, U.S.A. ©2012 Shopko Stores Operating Co., LLC Dark Raspberry Bottle Label Principal Display Panel - Dark Raspberry", "Package/Label Principal Display Panel - Bottle Label bath+body+etc ® Red Pomegranate antibacterial deep cleansing hand soap 10.1 fl oz Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For Shopko Stores Operating Co., LLC Green Bay, WI 54307, U.S.A. ©2012 Shopko Stores Operating Co., LLC Red Pomegranate Bottle Label Principal Display Panel - Red Pomegranate" ], "indications_and_usage": [ "Uses handwashing to decrease bacteria on skin" ], "set_id": "da428ddd-de07-4b5d-ab9b-1de508ba7957", "id": "da428ddd-de07-4b5d-ab9b-1de508ba7957", "active_ingredient": [ "Active ingredient Triclosan 0.2%" ] }, { "effective_time": "20110103", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE, VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200)." ], "purpose": [ "PURPOSE ANTISEPTIC" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS. KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER." ], "questions": [ "QUESTIONS OR COMMENTS 1-866-695-3030" ], "spl_product_data_elements": [ "VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL GLYCERIN ISOPROPYL MYRISTATE AMINOMETHYLPROPANOL CARBOMER 934 .ALPHA.-TOCOPHEROL ACETATE, D- VANILLA APPLE ALOE VERA LEAF MANNITOL POWDERED CELLULOSE HYPROMELLOSES FERRIC OXIDE RED D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT A TEMPERATURE BELOW 110 0 F (43 0 C)." ], "package_label_principal_display_panel": [ "PACKAGE FRONT AND BACK LABELS IMAGE OFVANILLA CREAM AND APPLE BLOSSOM LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE BACTERIA ON THE SKIN." ], "set_id": "db92fb7a-e531-4652-ab6a-ede0625db589", "id": "77cc3aa7-aaaf-4185-8f57-ddbbd7941cb1", "active_ingredient": [ "ACTIVE INGREDIENT ETHYL ALCOHOL 62 PERCENT" ] }, { "effective_time": "20120611", "inactive_ingredient": [ "Inactive Ingredients Olive Oil (INCI name: Olea Europaea (Olive) Vanilla (INCI Name: Vanillin)" ], "purpose": [ "Purpose Massage Oil to assist with relief of joint and muscle pain" ], "keep_out_of_reach_of_children": [ "Keep out of Reach of Children Keep Out of Reach of Children" ], "warnings": [ "Warnings For external use only. In case of accidental ingestion, get medical help or contact a Poisons Control Center right away." ], "spl_product_data_elements": [ "Golf Pain Away GPA Tea Tree OIl and Eucalyptus Oil TEA TREE OIL Tea Tree Oil EUCALYPTUS OIL EUCALYPTUS OIL Olive Oil" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and Administration Apply a small amount of Golf Pain Away to the pain affected area and gently massage in until fully absorbed. Use before and after golf for maximum relief." ], "package_label_principal_display_panel": [ "Product Label GPA Label" ], "indications_and_usage": [ "Indication and Usage Temporary relief of joint and muscle pain, including lower back pain" ], "set_id": "dc49e6a7-afa2-4229-8156-7004bea26acb", "id": "48d9793a-aed9-47b0-a246-e767b201bc7f", "active_ingredient": [ "Active Ingrdeints Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml) Eucalyptus Oil (E. Polybractea) - 3.86% (38.6 mg/ml)" ] }, { "effective_time": "20130702", "purpose": [ "Active Ingredients (in each 1 mL dropperful) Purpose Chlorpheniramine Maleate 1 mg Antihistamine Dextromethorphan HBr 3 mg Antitussive Phenylephrine HCl 2 mg Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately." ], "when_using": [ "Do not exceed recommended dosage.", "When using this product excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase drowsiness effect" ], "questions": [ "Questions? Comments? Call 1-732-721-0070" ], "storage_and_handling": [ "Other information Store at 59°-86°F (15°-30°C)" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages" ], "set_id": "e0358508-58f3-47fb-9471-3c143f752146", "id": "980e54fd-9f8b-4351-935f-c3e1ea6296d2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers." ], "active_ingredient": [ "Active Ingredients (in each 1 mL dropperful) Purpose Chlorpheniramine Maleate 1 mg Antihistamine Dextromethorphan HBr 3 mg Antitussive Phenylephrine HCl 2 mg Decongestant" ], "dosage_and_administration_table": [ "
Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4 to 6 hours, not to exceed 4 doses (8 dropperfuls) in a 24 hour period.
Children under 6 years of age: Consult a physician
" ], "inactive_ingredient": [ "Inactive ingredients Citric Acid, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose, Vanilla flavor" ], "warnings": [ "Warnings Do not exceed recommended dosage. Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a persistent or chronic cough such as occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase drowsiness effect Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Trigofen DM Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Chlorpheniramine Maleate Chlorpheniramine Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine Citric Acid Monohydrate Methylparaben Potassium Citrate Potassium Sorbate Propylparaben Propylene Glycol Water Sorbitol Sucralose" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a persistent or chronic cough such as occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Do not exceed recommended dosage. Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4 to 6 hours, not to exceed 4 doses (8 dropperfuls) in a 24 hour period. Children under 6 years of age: Consult a physician" ], "package_label_principal_display_panel_table": [ "
Active Ingredients:
Each dropperful (1mL) contains:
Chlorpheniramine Maleate 1 mg
Dextromethorphan HBr 3 mg
Phenylephrine HCl 2 mg
" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur" ], "do_not_use": [ "Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product" ], "active_ingredient_table": [ "
Active Ingredients (in each 1 mL dropperful) Purpose
Chlorpheniramine Maleate 1 mg Antihistamine
Dextromethorphan HBr 3 mg Antitussive
Phenylephrine HCl 2 mg Decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 mL Carton NDC 13811-0082-30 Trigofen DM Drops Antihistamine • Cough Suppressant Decongestant Sugar Free • Alcohol Free • Dye Free Orange-Vanilla Flavor Active Ingredients: Each dropperful (1mL) contains: Chlorpheniramine Maleate 1 mg Dextromethorphan HBr 3 mg Phenylephrine HCl 2 mg TRIGEN LABORATORIES Sayerville, NJ 08872 Net Contents: 1 fl. oz. (30 mL) Principal Display Panel - 30 mL Carton" ], "purpose_table": [ "
Active Ingredients (in each 1 mL dropperful) Purpose
Chlorpheniramine Maleate 1 mg Antihistamine
Dextromethorphan HBr 3 mg Antitussive
Phenylephrine HCl 2 mg Decongestant
" ] }, { "effective_time": "20101216", "inactive_ingredient": [ "Inactive Ingredients: WATER/EAU SD ALCOHOL 40-B SILICA KAOLIN MAGNESIUM ALUMINUM SILICATE SORBITAN LAURATE CITRIC ACID GLYCERIN POLYSORBATE 20 ZINC OXIDE PYRUS MALUS (APPLE) JUICE VANILLA PLANIFOLIA FRUIT EXTRACT ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT CINNAMOMUM CASSIA BARK EXTRACT TOCOPHERYL ACETATE CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT HYDROXYETHYLCELLULOSE TETRASODIUM EDTA FARNESYL ACETATE BUTYLENE GLYCOL CAPRYLIC/CAPRIC TRIGLYCERIDE PANTHENYL TRIACETATE ISOPROPYL MYRISTATE DIPROPYLENE GLYCOL TITANIUM DIOXIDE/CI 77891" ], "purpose": [ "Purpose Acne Treatment" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only When using this product avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists seek medical attention. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical medication at a time. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Flammable. Keep away from heat or flame." ], "when_using": [ "When using this product avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists seek medical attention. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical medication at a time." ], "questions": [ "Questions? Call 1-800-MEET-MARK image of carton image of carton" ], "spl_product_data_elements": [ "mark. Get Treatment Anti-Acne Overnight Treatment Salicylic Acid SALICYLIC ACID SALICYLIC ACID WATER MAGNESIUM ALUMINUM SILICATE GLYCERIN POLYSORBATE 20 ZINC OXIDE TITANIUM DIOXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions cleanse skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed of as directed by a doctor if bothersome dryness, irritation of peeling occurs, reduce application to every other day" ], "storage_and_handling": [ "Flammable. Keep away from heat or flame." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses for the treatment of acne clears up acne blemishes helps prevent new acne blemishes from forming penetrates pores to eliminate most blackheads and acne pimples" ], "set_id": "e4051a02-708d-4a01-ab64-205fbe6c3c34", "id": "fb5d4ccb-1f32-4cd5-a074-1a0102013e2e", "active_ingredient": [ "Active Ingredient Salicylic Acid 1.7% Purpose Acne Treatment" ] }, { "effective_time": "20091208", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Water, Coco Glycerides*, Safflower Fatty Acids*, Coconut Fatty Acids*, Glycerin*, Bentonite, Silicia, Vanilla* ( Vanilla planifolia ) Fruit Flavour, Peppermint* ( Mentha piperita) Oil, Tocopherol (vitamin E), Potasium Hydroxide. *Certified organic" ], "purpose": [ "USES: To decrease bacteria on the skin that could cause disease. Recommended for repeated use. Kills 99.9% of common harmful germs and bacteria within 30 seconds." ], "warnings": [ "Cautions and Warnings: For external use only. Flammable, keep away from fire or flame. Keep out of reach of children. Store at 20 to 25ºC. May discolor some fabrics." ], "spl_product_data_elements": [ "Naturally Nova Scotia Hand Sanitizer Ethyl Alcohol Alcohol Alcohol" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS: Apply to hands and rub in thoroughly until dry." ], "package_label_principal_display_panel": [ "Master Label" ], "set_id": "e58b79f9-bb3b-4aba-824c-57a312555468", "id": "0beb6e6e-35df-45d5-b70c-fbb13f131f40", "active_ingredient": [ "ACTIVE INGREDIENT: Ethyl Alcohol* (Antiseptic) 62%" ] }, { "effective_time": "20141028", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane, Water, Isododecane, Isopentyldiol, Styrene/Acrylates Copolymer, PEG-10 Dimethicone, Sea Salt (Maris Sal), HDI/PPG/Polycaprolactone Crosspolymer, Dimethicone, Sorbitan Stearate, PPG-12/SMDI Copolymer, Polyglyceryl-6 Polyricinoleate, Disteardimonium Hectorite, Alumina, Niacinamide, Camellia Sinensis (Green Tea) Leaf Extract, Vanilla Tahitensis Fruit Extract, Tocopherol, Ascorbic Acid, Tocopheryl Acetate, Butylene Glycol, Boron Nitride, Sodium Citrate, Dipropylene Glycol, Polymethyl Methacrylate, Silica, Triethyl Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Myristate, Acrylates/Ammonium Methacrylate Copolymer, Polyglyceryl-2 Isostearate, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer,Polyglyceryl-6 Polyricinoleate, Methicone, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499), Chromium Hydroxide Green (CI 77289), Yellow 5 (CI 19140), Chromium Oxide (CI 77288)." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "NUANCE SALMA HAYAK Color and Correct CC Cream Broad Spectrum SPF 20 Sunscreen TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE CYCLOMETHICONE 5 WATER ISODODECANE ISOPENTYLDIOL SEA SALT DIMETHICONE SORBITAN MONOSTEARATE PPG-12/SMDI COPOLYMER DISTEARDIMONIUM HECTORITE ALUMINUM OXIDE NIACINAMIDE GREEN TEA LEAF VANILLA TOCOPHEROL ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE BUTYLENE GLYCOL BORON NITRIDE SODIUM CITRATE DIPROPYLENE GLYCOL SILICON DIOXIDE TRIETHYL CITRATE ISOPROPYL MYRISTATE POLYGLYCERYL-2 MONOISOSTEARATE PHENOXYETHANOL FERRIC OXIDE RED FERROSOFERRIC OXIDE CHROMIUM HYDROXIDE GREEN FD&C YELLOW NO. 5 CHROMIC OXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • Apply generously 15 minutes before sun exposure. • Children under 6 months: Ask a doctor • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating: • Reapply immediately after towel drying" ], "spl_unclassified_section": [ "Drug Facts", "Other information Protect this product from excessive heat and direct sun", "NUANCE SALMA HAYEK \"Inspired by my grandmother, my products are designed to help every woman enhance the nuances that define her individual beauty.\" Salma COLOR and CORRECT CC CREAM This lightweight formula was developed with all the benefits of a BB cream, with added color to help visually improve the appearance of skin tone and provide effective skin coverage, minimizing the look of imperfections. Contains Antioxidant Vitamins C and E. Dermatologist Tested No Parabens Not Tested on Animals Once applied, green tint converts to universally match most skin tones. BEAUTY SECRET Throughout history, women around the world have extracted Vitamin C from natural resources to reap its antioxidant benefits. In ancient Tibet, women would rub berries with a high Vitamin C content on their face and hands to help improve the appearance of skin tone." ], "stop_use": [ "Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "package_label_principal_display_panel": [ "Product Labels InnerLabel OuterLabel" ], "indications_and_usage": [ "Use (s) • Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "e63d1161-8958-4823-9661-09fbec446adb", "id": "74ed2f85-4eef-467e-b4a8-9afdf5d6df23", "active_ingredient": [ "Active ingredients Titanium Dioxide 7.7% Purpose Sunscreen" ] }, { "effective_time": "20100913", "inactive_ingredient": [ "Inactive ingredients Acesulfame potassium, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH." ], "purpose": [ "Purposes Cough Suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have a cough that occurs with too much phlegm (mucus) a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions and comments? Call 1-800-899-3116 , Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number." ], "spl_product_data_elements": [ "Diabetic Tussin DM Dextromethorphan hydrobromide and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM CHERRY VANILLA ASPARTAME HYPROMELLOSE MENTHOL METHYLPARABEN POTASSIUM SORBATE WATER ANHYDROUS CITRIC ACID" ], "ask_doctor": [ "Ask a doctor before use if you have a cough that occurs with too much phlegm (mucus) a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take every 4 hours do not exceed 6 doses in 24 hours adults & children 12 years & over 10 mL (2 teaspoonfuls) children 6 years to under 12 years 5 mL (1 teaspoonful) children 2 years to under 6 years 2.5 mL (½ teaspoonful) children under 2 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL) Storage store at room temperature 20-25ºC (68-77ºF) keep tightly closed" ], "storage_and_handling": [ "Storage store at room temperature 20-25ºC (68-77ºF) keep tightly closed" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Package Principal Display Panel NDC 61787-062-04 Diabetic Tussin ® DM Cough Suppressant / Expectorant Relieves Coughs Soothes Throat Relieves Chest Congestion Liquid No Sodium, Dye, Codeine, Sorbitol, Fructose Sugar & Alcohol Free! Safe for Diabetics 4 Fl. Oz. (118 mL) image of 4 fl oz carton" ], "indications_and_usage": [ "Uses temporarily relieves cough helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus" ], "set_id": "e70bcb6c-6ffb-474f-b388-7a6c8cc8c146", "id": "e70bcb6c-6ffb-474f-b388-7a6c8cc8c146", "active_ingredient": [ "Active ingredients (in each 5 mL) Dextromethorphan HBr 10 mg Guaifenesin 100 mg" ], "dosage_and_administration_table": [ "
adults & children 12 years & over 10 mL (2 teaspoonfuls)
children 6 years to under 12 years 5 mL (1 teaspoonful)
children 2 years to under 6 years 2.5 mL (½ teaspoonful)
children under 2 years ask a doctor
" ] }, { "effective_time": "20140220", "inactive_ingredient": [ "Inactive Ingredients Neem Leaf Extract (aqueous), Decyl Polyglucose, Shea Butter (Butyrospermum parkii), Vanilla Extract, Spearmint Essential Oil, Emulsifying Wax, Stearic Acid, Citric Acid." ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use if significant irritation or sensitization occurs." ], "warnings": [ "Warnings For external use only When using this product avoid contact with eyes. In case of eye contact, flush with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use if significant irritation or sensitization occurs." ], "when_using": [ "When using this product avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions: call 1-800-664-8009" ], "spl_product_data_elements": [ "Every Day Shea Foaming Shea Butter Hand Sanitizer Vanilla Mint BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM AZADIRACHTA INDICA LEAF SHEA BUTTER CETOSTEARYL ALCOHOL BEHENTRIMONIUM CHLORIDE DECYL GLUCOSIDE STEARIC ACID CITRIC ACID MONOHYDRATE VANILLA SPEARMINT OIL" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together briskly until dry" ], "spl_unclassified_section": [ "Every Day Shea Foaming Shea Butter Hand Sanitizer Vanilla Mint Drug Facts", "Handmade in the USA by Allafia www.EveryDayShea.com Olympia, WA 98501" ], "package_label_principal_display_panel": [ "Every Day Shea Foaming Shea Butter Hand Sanitizer Vanilla Mint 12oz (51441-012-12) VanillaMint" ], "indications_and_usage": [ "Uses For hand sanitizing to reduce bacteria on skin Recommended for repeated use." ], "set_id": "e794bc7c-04a2-4d18-ad4b-3e1744d1c4d2", "id": "bd42a328-ad86-49d9-87a5-9472c2adcaaa", "active_ingredient": [ "Active Ingredient Benzalkonium Chloride 0.11%" ] }, { "effective_time": "20120510", "inactive_ingredient": [ "Ricinus Communis (Castor) Seed Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Simmondsia Chinensis (Jojoba) Seed Oil (1), Lanolin, Citrus Aurantifolia (Lime) Oil, Copernicia Cerifera (Carnauba) Wax, Glycine Soja (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Olea Europaea (0live)Fruit Oil, Echinacea Purpurea Extract, Vanilla Planifolia Fruit Extract, Ammonium Glycyrrhizate, Tocopherol, Tocopheryl Acetate. (1) Certified Organic Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if skin rash occurs." ], "questions": [ "Questions? Call 888-659-7730 or visit www.AlbaBotanica.com" ], "spl_product_data_elements": [ "Alba Botanica UN-petroleum Tangerine SPF18 Lip Balm Ethylhexyl Dimethyl PABA, Benzophenone-3 PADIMATE O PADIMATE O OXYBENZONE OXYBENZONE CASTOR OIL YELLOW WAX CANDELILLA WAX JOJOBA OIL LANOLIN CARNAUBA WAX SOYBEAN OIL EVENING PRIMROSE OIL OLIVE OIL ECHINACEA PURPUREA AMMONIUM GLYCYRRHIZATE TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE LIME OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 mos ask a doctor. Skin Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging." ], "package_label_principal_display_panel": [ "image of container label image of carton label" ], "indications_and_usage": [ "Helps prevent sunburn" ], "set_id": "e8916a9c-14e8-4c59-9f86-ab3b1145e8dc", "id": "83efe10f-ee4b-42f7-a57b-1c8ac81e549e", "active_ingredient": [ "Ethylhexyl Dimethyl PABA 7.5% Benzophenone-3 5.0%" ] }, { "effective_time": "20120611", "inactive_ingredient": [ "Inactive Ingredients Eucalyptus Leaf Oil (Eucalyptus Polybractea), Leptospermum Petersonii Leaf Oil (Leptospermum Petersonii), Tea Tree Oil ( Melaleuca Alternifolia) Vanilla,Actilastin 1000," ], "purpose": [ "Purpose Sunscreen and Insect Repellent." ], "keep_out_of_reach_of_children": [ "Keep out of Reach of Children Keep Out of Reach of Children" ], "warnings": [ "Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center right away. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF or 15 or higher and other sun protection measures including: limit time in the sun, especially between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. children under 6 months: Ask a doctor." ], "spl_product_data_elements": [ "Outback 2-in-1 Insect Repellent and Protective Sunscreen Octinoxate,4-Methylbenzylidene Camphor and Zinc OCTINOXATE OCTINOXATE ENZACAMENE ENZACAMENE Zinc Oxide Zinc Oxide EUCALYPTUS POLYBRACTEA LEAF OIL LEPTOSPERMUM PETERSONII LEAF OIL TEA TREE OIL vanila" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and Administration Apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours." ], "package_label_principal_display_panel": [ "Product Label obc 1 lab obc 2 lab" ], "indications_and_usage": [ "Indication and Usage Helps prevent sunburn. if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "ea926d9b-7bb5-4480-98b8-d80e4b3f1a67", "id": "3b04cd1f-ed03-47df-9315-1a085ec373c1", "active_ingredient": [ "Active ingrdient Octyl Methoxycinnamate - 9% (90 mg/ml) 4-Methylbenzylidene Camphor - 1.3% (13 mg/ml) Zinc Oxide - 8% (80 mg/ml)" ] }, { "effective_time": "20150202", "inactive_ingredient": [ "Inactive Ingredients: CAPRYLIC/CAPRIC TRIGLYCERIDE - CYCLOMETHICONE - C12-15 ALKYL BENZOATE - DIETHYLHEXYL SUCCINATE - HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL - FRAGRANCE - TOCOPHERYL ACETATE - PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE - VANILLA TAHITENSIS FRUIT EXTRACT - BHT - BENZYL SALICYLATE - LIMONENE - BUTYLPHENYL METHYLPROPIONAL - HEXYL CINNAMAL - CITRONELLOL." ], "purpose": [ "Uses: - helps prevent sunburn - higher SPF gives more sunburn protection - for skin that sunburns minimally - retains SPF after 40 minutes of acti vity in water" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only" ], "when_using": [ "When using this product: - keep out of eyes. Rinse with water to remove" ], "spl_product_data_elements": [ "Clarins Sunscreen Care Radiant SPF 6 UVB/UVA OCTINOXATE, AVOBENZONE OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE MEDIUM-CHAIN TRIGLYCERIDES CYCLOMETHICONE C12-15 ALKYL BENZOATE HELIANTHUS ANNUUS FLOWERING TOP PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE VANILLA BUTYLATED HYDROXYTOLUENE BENZYL SALICYLATE BUTYLPHENYL METHYLPROPIONAL .ALPHA.-HEXYLCINNAMALDEHYDE .BETA.-CITRONELLOL, R-(+)-" ], "description": [ "Sunscreen Care Radiant Oil Spray For body and hair SPF 6 Minimal protection sun care ideal for darker skin tones or already tanned skin. - Light and fluid oil. - Water and perspiration resistant. - Hydrates and enhances beauty skin thanks to sunflower oil and tahitian vanilla extract. - Protects hair from the drying effects of sun and salt. Allergy tested. www.clarins.com CLARINS PARIS - 92200 Neuilly France 95300 Pontoise Made in France - Marques deposees" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: - apply liberally before sun exposure - reapply as needed or after towel drying, swimming or perspiring - do not use on infants under 6 months of age." ], "stop_use": [ "Stop use and ask a doctor if: - rash or irritation develops and lasts" ], "spl_unclassified_section": [ "Other Information: Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun." ], "package_label_principal_display_panel": [ "CLARINS PARIS 6 SPF MINIMALE PROTECTION UVB / UVA Sunscreen Care Radiant Oil Spray For body and hair - WARNINGS: for external use only. When using this product: keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions: apply liberally before sun exposure. Reapply as needed or after towel drying, swimming or perspiring.Do not use on infants under 6 months of age. Allergy tested. ACTIVE INGREDIENTS: OCTINOXATE 7.5% - AVOBENZONE 3%. 12 M ref. 14531 9 CLARINS PARIS - 92200 Neuilly France 95300 Pontoise Made in France 150 mL 5.1 Fl. Oz.", "\"CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients.\" Jacques Courtin Clarins www.clarins.com CLARINS SUN DAMAGE CONTROL CARE MULTI CELLULAR PROTECTION CLARINS P A R I S 6 S P F MINIMALE PROTECTION / MINIMAL PROTECTION UVB / UVA Sunscreen Care Radiant Oil Spray For body and hair e 150 mL 5.1 Fl. Oz. www.clarins.com WITH PLANT EXTRACTS CLARINS-PARIS CLARINS PARIS - 92200 Neuilly France 95300 Pontoise Made in France 12 M ref. 14531 9", "Clarins 6-SPF Minimale Protection Oil Spray Inner", "Clarins 6-SPF Minimale Protection Oil Spray Outer" ], "set_id": "ebde4226-490d-40df-b07c-36c20ee050fe", "id": "7c1512db-3b1e-4f81-bbbb-6d4d82e81242", "active_ingredient": [ "Active Ingredients Purpose OCTINOXATE 7.5% Sunscreen AVOBENZONE 3% Sunscreen" ] }, { "effective_time": "20130509", "inactive_ingredient": [ "Other Ingredients: Micro-Swelling Defense Complex I: [Water(aqua), Morinda citrifolia (Noni) Fruit Juice, Morinda citrifolia(Noni) Leaf Juice, Morinda Citrifolia (Noni) Leaf Extract], Cetearyl Alcohol, C12-15 Alkyl Benzoate, Dimethicone, Butylene Glycol, Cetearyl Glucoside, Morinda citrifolia (Noni) Seed Oil, Centella asiatica (Hydrocotyl) Extract, Curcuma longa (Turmeric) Root Extract, Glycine soja (Soybean) Seed Sterol, Glycine soya (Soybean) Seed Extract, Macrocystis pyrifera (Kelp) Extract Monoi Oil [Cocos nucifera Oil, Gardenia tahentensis (Tiare) Flower], Moringa oleifera Seed Oil, Musa sapeintum (Banana) Extract, Pikea robusta (red Algae) Extract, Vanilla tehitensis (Vanilla) Fruit Extract, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Xanthan Gum, Panthenol, Potassium Sorbate, Fragrance(Parfum), Disodium EDTA, Ceramide 3. Ethoxydiglycol, Sodium Hyaluronate." ], "warnings": [ "Warnings: For external use only. Keep out of eyes. If contact occurs, rinse with water to remove. Stop use and ask a doctor if rash or irritation develops. Keep out of reach of children." ], "spl_product_data_elements": [ "Tahitian Noni TePoema Element Shield SPF 20 Avobenzone, Octinoxate, Octisalate OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE WATER CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE POLYOXYL 100 STEARATE PHENOXYETHANOL DIMETHICONE SOYBEAN BUTYLENE GLYCOL TURMERIC PANTHENOL PROPYLENE GLYCOL VANILLA XANTHAN GUM HYALURONATE SODIUM COCONUT OIL DIETHYLENE GLYCOL MONOETHYL ETHER CENTELLA ASIATICA POTASSIUM SORBATE EDETATE DISODIUM" ], "description": [ "Element Shield This light lotion disappears into skin yet provides long lasting UVA and UVB protection." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions: After moisturizing , apply smoothly over face and neck before sun exposure, contact with harsh elements or pollution and as needed. This should always be your last step in the regimen." ], "package_label_principal_display_panel": [ "Tahitian Noni Authentic TePoema Regimens Element Shield SPF 20 Sunscreen Protects All Skin Types UVA and UVB protection Protection contra rayos UV 50ml 1.7 FL.OZ. Element Shield" ], "set_id": "f377fb8b-8bed-4162-88c0-bcce0859b04d", "id": "4d09266b-c7c4-40d9-b59a-ffde8cdee732", "active_ingredient": [ "Active Ingredients: Avobenzone 2%, Octinoxate 7.5%, Octisalate 5%." ] }, { "effective_time": "20150608", "inactive_ingredient": [ "INACTIVE INGREDIENT INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone, Niacinamide, Cetyl Ethylhexanoate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Pentylene Glycol, Sorbitan Isostearate, Isoamyl p-Methoxycinnamate, Mica (CI 77019), Iron Oxides (CI 77492), Disteardimonium Hectorite, Magnesium Sulfate, Aluminum Hydroxide, PEG-8 Dimethicone, Phenoxyethanol, Glyceryl Tribehenate/Isostearate/Eicosandioate, Stearic Acid, Tribehenin, Fragrance, Iron Oxides (CI 77491), Dimethicone, Triethoxycaprylylsilane, Iron Oixdes (CI 77499), Dimethicone Crosspolymer, vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Ethylhexylglcerin, Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Cyclomethicone, Polysilicone-11, Lauroyl Lysine, Trehalose, Lavandula Angustifolia (Lavender) Flower Water, Ethylhexyl Palmitate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Silica Dimethyl Silylate, Lecithin, Pistacia Lentiscus (Mastic) Gum, Ceramide 3, Caprylyl Glycol, Actinidia Polygama Fruit Extract, Portulaca Oleracea Extract, Citric Acid, Vanilla Plantifolia Fruit Extract, Sodium Benzoate, Sodium Hyaluronate, Potassium Sorbate, Hexylene Glycol, Caprylhydroxamic Acid" ], "purpose": [ "PURPOSE PURPOSE: Sunscreen" ], "warnings": [ "WARNINGS WARNINGS: If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes." ], "spl_product_data_elements": [ "Cover 10 Perfect BB Light Titanium Dioxide, Octinoxate, Zinc Oxide Titanium Dioxide TITANIUM DIOXIDE Octinoxate OCTINOXATE Zinc Oxide ZINC CATION Water Glycerin" ], "description": [ "INDICATIONS & USAGE INDICATIONS & USAGE: Spread gently onto face and blend to desired coverage." ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton" ], "set_id": "f5e75045-e30a-47ae-a356-5f297b127d98", "id": "f6f083c3-7e3b-4004-a779-0f92944dc890", "active_ingredient": [ "ACTIVE INGREDIENT ACTIVE INGREDIENTS: Titanium Dioxide (CI 77891) (15.71%), Ethylhexyl Methoxycinnamate (7.0%), Zinc Oxide (CI 77947) (3.91%)" ] }, { "effective_time": "20120321", "inactive_ingredient": [ "Inactive Ingredients Rebel ocean breeze Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Red 40, Yellow 5 Drama queen vanilla kiss Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines Candy apple Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Red 33, Red 40, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines Sweet melon Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aqua, Blue 1, Cellulose, Hydroxypropyl Methylcellulose, Lactose, Parfum, Polysorbate 20, Propylene Glycol, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Ultramarines, Yellow 5" ], "purpose": [ "PURPOSE Anti-bacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. Flammable, keep away from fire or flame. Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. If contact occurs, rinse thoroughly with water. Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor." ], "questions": [ "QUESTIONS? 1-800-FDA-1088 Made in China Distributed by Jets, Sets & Elephants Beauty Corp. For ShopKo Stores Operating Co., LLC Green Bay, WI 54307, U.S.A ©2010 ShopKo Stores Operating Co., LLC" ], "spl_product_data_elements": [ "Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE FD&C RED NO. 40 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE D&C RED NO. 33 FD&C BLUE NO. 1 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE FD&C RED NO. 40 D&C RED NO. 33 Shopko Antibacterial Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER PROPYLENE GLYCOL ALOE VERA LEAF POLYSORBATE 20 TROLAMINE VITAMIN A PALMITATE LACTOSE HYPROMELLOSE 2208 (100 MPA.S) .ALPHA.-TOCOPHEROL ACETATE ULTRAMARINE BLUE FD&C BLUE NO. 1 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Apply to hands until thoroughly wet. Rub vigorously until dry. Supervise children in the use of this product." ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath body etc ® Rebel ocean breeze anti-bacterial hand gel 1 fl. oz. Rebel ocean breeze Bottle Label Rebel ocean breeze Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath body etc ® Drama queen vanilla kiss anti-bacterial hand gel 1 fl. oz. Drama queen vanilla kiss Bottle Label Drama Queen vanilla kiss Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath body etc ® Candy apple anti-bacterial hand gel 1 fl. oz. Candy apple Bottle Label Candy apple Bottle Label", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL bath body etc ® Sweet melon anti-bacterial hand gel 1 fl. oz. Sweet melon Bottle Label Sweet melon Bottle Label" ], "indications_and_usage": [ "USE To decrease bacteria on the skin and clean hands. Recommended for repeated use." ], "set_id": "f62761bb-26fb-41b6-99e0-69f321a3d636", "id": "f62761bb-26fb-41b6-99e0-69f321a3d636", "active_ingredient": [ "ACTIVE INGREDIENT Ethyl Alcohol 62% w/w" ] }, { "effective_time": "20150113", "inactive_ingredient": [ "Inactive ingredients Glycerin, Orange-Vanilla Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol." ], "purpose": [ "Purpose Antihistamine Cough Suppressant Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not exceed recommended dosage." ], "when_using": [ "When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness" ], "questions": [ "Questions? Comments? 1-888-455-5253 , M-F: 8:00 a.m. - 5:00 p.m. CST Serious side effects associated with use of this product may be reported to this number. Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110" ], "spl_product_data_elements": [ "Nasohist DM Pediatric Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride Chlorpheniramine Maleate Chlorpheniramine Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Administer each dose four times per day using provided dropper. Do not exceed recommended dosage AGE DOSE* Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hrs, or as directed by a doctor. Children under 6 years of age: Consult a physician. *In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur" ], "storage_and_handling": [ "Other information Store at Controlled Room Temperature 20°- 25°C (68°- 77°F); excursions permitted 15°- 30°C (59°- 86°F). [See USP Controlled Room Temperature]." ], "do_not_use": [ "Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product" ], "package_label_principal_display_panel": [ "Product Packaging The packaging below represents labeling currently used: Principal display panel and side panel for 30 mL label: NDC 63717-325-30 nasohist DM pediatric drops Antihistamine / Cough Suppressant / Nasal Decongestant Each dropperful (1 mL) for oral administration contains: Chlorpheniramine Maleate........................1 mg Dextromethorphan HBr...........................3 mg Phenylephrine HCl.................................2 mg Sugar Free / Alcohol Free Dye Free Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Supplied in a tight, light-resistant container with a child-resistant cap. See package insert for full prescribing information. Mfg for: Hawthorn Pharmaceuticals, Inc. Madison, MS 39110 HL177 Rev. 05/11 Nasohist DM Pediatric Drops Packaging Nasohist DM Pediatric Drops Packaging Nasohist DM Pediatric Drops Packaging" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages" ], "set_id": "f6933131-8e8d-47f8-9903-c7d43c253f51", "id": "598c9710-c019-4b13-a1f0-b662b6c32b09", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers." ], "active_ingredient": [ "Drug Facts Active ingredients (in each 1 mL dropperful) Chlorpheniramine Maleate, USP 1 mg Dextromethorphan Hydrobromide, USP 3 mg Phenylephrine Hydrochloride, USP 2 mg" ], "dosage_and_administration_table": [ "
AGE DOSE*
Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hrs, or as directed by a doctor.
Children under 6 years of age: Consult a physician.
" ] }, { "effective_time": "20110803", "inactive_ingredient": [ "INACTIVE INGREDIENT Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Isostearyl Neopentanoate, Hydrogenated Polyisobutene, Glycerin, Phenyl Trimethicone, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Petrolatum, PEG-8, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter) Extract, Phospholipids, Pentaerythrityl Tetraethylhexanoate, Cucumis Sativus (Cucumber) Juice, Lycium Chinese Fruit Extract, Panax Ginseng Root Extract, Salvia Officinalis (Sage) Leaf Extract, Vanilla Tahitensis Fruit Extract, Sodium Hyaluronate, Lactic Acid, Tocopheryl Acetate, Arginine, Carnosine, Glycine, Lysine, Proline, Propylene Glycol, Sodium PCA, Trehalose, Urea, Hydrogenated Lecithin, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearyl Alcohol, Stearic Acid, Polyquaternium-51, Ethoxydiglycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Xanthan Gum, Citric Acid, Triethanolamine, Sodium Sulfite, Disodium EDTA, Hydroxypropyl Starch Phosphate, Dimethiconol, Parfum/Fragrance, Butylene Methylpropional, Limonene, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Potassium Sorbate, Propylparaben, Sodium Benzoate, Chlorphensin." ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children." ], "purpose": [ "OTC - PURPOSE Provides SPF 15 sun protection." ], "warnings": [ "WARNINGS Warning: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor. Keep out of reach of children." ], "when_using": [ "OTC - WHEN USING Avoid contact with eyes." ], "spl_product_data_elements": [ "Elizabeth Arden Moisture Shield SPF 15 Octinoxate OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE AVOBENZONE AVOBENZONE WATER GLYCERIN PHENYL TRIMETHICONE BUTYLENE GLYCOL PHENOXYETHANOL PETROLATUM SHEA BUTTER CUCUMBER JUICE LACTIC ACID ARGININE CARNOSINE GLYCINE LYSINE PROLINE PROPYLENE GLYCOL TREHALOSE UREA SUCROSE STEARIC ACID XANTHAN GUM SODIUM SULFITE BUTYLPHENYL METHYLPROPIONAL BENZOIC ACID BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN METHYLPARABEN POTASSIUM SORBATE PROPYLPARABEN SODIUM BENZOATE CHLORPHENESIN" ], "description": [ "DESCRIPTION This lightweight, moisturizing lotion provides the ideal level of hydration as it shields skin from the damaging effects of UV rays. Skin feels restored and rebalanced, and looks healthy and glowing." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Smooth on to face." ], "package_label_principal_display_panel": [ "MoistureShieldBottle" ], "indications_and_usage": [ "INDICATIONS AND USAGE To Use: Smooth on to face before sun exposure." ], "set_id": "f8832036-fe7a-43a4-849a-26e254ebd95b", "id": "ae6f4a9b-b4b6-4642-ac04-553fbd0571b9", "active_ingredient": [ "OTC - ACTIVE INGREDIENT Active Ingredients: Octinoxate 6.25% W/W, Octisalate 5.00% W/W, Oxybenzone 2.00% W/W, Avobenzone 1.50% W/W." ] } ] }