{ "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": "2026-08-07", "results": { "skip": 0, "limit": 100, "total": 853 } }, "results": [ { "effective_time": "20130320", "inactive_ingredient": [ "Ingredients : Purified Water, Ethyl Alcohol, Hamammelis Extract, Chamomile Extract, Salicyl Alcohol, Ethhylene Glycol, Propylene Glycol, Dodecyl Benzene Sulfonate, EDTA, Methylparaben, Propylparaben. Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben." ], "purpose": [ "Uses: For the management of acne helps clear up acne blemishes, black heads, helps prevent the development of new acne pimples penetrates pores to reduce the number of acne pimples, white heads and black heads help keep skin clear of new acne pimples, white heads and black heads helps prevent new acne pimples, white heads and black heads from forming help prevent the development of new pimples, white heads and black heads" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact a Poison Control center immediately." ], "warnings": [ "Warnings: For external use only. Do not use if you have sensitive skin and/or are sensitive to [active ingredient] When using this product 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 acne medication at a time avoid unnecessary sun exposure and use sun screen, Acne Clearing Moisture with SPF 45 skin irritation may occur, characterized by redness, burning, itching, peeling, and possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration Stop use and ask a doctor if irritation becomes severe" ], "spl_product_data_elements": [ "Acne Clearning Treatment Face SULFUR, BENZOYL PEROXIDE, SALICYLIC ACID SULFUR SULFUR BENZOYL PEROXIDE BENZOYL PEROXIDE SALICYLIC ACID SALICYLIC ACID WATER CATALINA ARNICA MONTANA GLYCERIN CETYL ALCOHOL CETEARETH-12 BROMELAINS CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) MINERAL OIL ETHYLENE GLYCOL PROPYLENE GLYCOL SODIUM ASCORBYL PHOSPHATE TROLAMINE ASCORBIC ACID DODECYLBENZENESULFONIC ACID PEPPERMINT OIL PIPERINE MINT EDETIC ACID BUTYLATED HYDROXYTOLUENE METHYLPARABEN PROPYLPARABEN VITAMIN A POMEGRANATE GREEN TEA LEAF" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Three Bottles Acne Clearing Cleanser 240 mL Acne Clearing Tonic 120 mL Acne Clearing Treatment 101 60 mL" ], "package_label_principal_display_panel": [ "Acne Clearing Treatment - FACE labels" ], "indications_and_usage": [ "Directions: Acne Clearing Cleanser Acne Clearing Tonic Acne Clearing Treatment 101" ], "set_id": "0001eaa9-e890-4e94-9d44-47a0f3086a02", "id": "d08e6fbf-9162-47cd-9cf6-74ea24d48214", "active_ingredient": [ "Active Ingredient....................................Purpose Sulphur 5%...............................................Acne medication Benzoyl Peroxide 2.5%...............................Acme medication Salicylic acid 2%........................................Acne medication" ] }, { "effective_time": "20120120", "inactive_ingredient": [ "Inactive ingredient Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil and Polyethylene Gycol *This product is not manufactured or by Purdue Frederick, owner of the registered trademark Senokot® Manufactured by: Contract Pharmacal Corp. 135 Adams Avenue Hauppauge, NY 11788 USA www.cpc.com R11/09" ], "purpose": [ "Purpose 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 Do not use laxative products for longer than one week unless directed by a doctor" ], "spl_product_data_elements": [ "Natural Senna Sennosides SENNOSIDES A AND B SENNOSIDES CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES MAGNESIUM SILICATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POLYETHYLENE GLYCOL 400 Mottled brown 1122" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain, nausea, or vomiting, noticed a sudden change in bowel habits that continue over a period of 2 weeks" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions preferable at bedtime adults – two tablets: maximum of 4 tablets twice daily children (6-12 years) one tablet: maximum 2 tablets twice daily Other information Store at room temperature, USP Contains 20 mg of calcium Side effects occur. You may report side effects to FDA at 1-800-FDA-1088 (Toll Free)." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative These may indicate a serious condition." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL f4a8921b-figure-01" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally causes bowel movement in 6-12 hours" ], "set_id": "002621a1-0f13-4e92-856b-5a850a48193e", "id": "f4a8921b-1b27-4768-887a-81bad872a378", "active_ingredient": [ "Active ingredient (in each rounded tablet) Sennosides from Senna Concentrate 8.6 mg" ] }, { "effective_time": "20120514", "inactive_ingredient": [ "Inactive Ingredients: Corn Oil, Light Mineral Oil, Vitamin A Palmitate, Vitamin D" ], "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": [ "For external use only. Avoid contact with eyes. on deep puncture wounds, animal bites, or serious burns. Stop use and ask a doctor if condition worsens, symptoms last for more than 7 days or clear up and occur again within a few days." ], "spl_product_data_elements": [ "A and D Petrolatum PETROLATUM PETROLATUM VITAMIN A PALMITATE ERGOCALCIFEROL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Apply liberally as needed Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Use with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged." ], "package_label_principal_display_panel": [ "MM1 H and H AD Carton.jpg" ], "indications_and_usage": [ "Uses-Temporarily protects minor cuts, scrapes, and sunburn. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects of wind and cold weather." ], "set_id": "00bc354f-9f7b-4288-9bbe-a140a6643d20", "id": "41f08daa-55b1-42ac-b2e2-4a8dd8883536", "active_ingredient": [ "Active Ingredient (in each gram): White Petrolatum 93.5%" ] }, { "effective_time": "20101206", "inactive_ingredient": [ "Inactive ingredients Aqua (Water), Glycerin, Butylene glycol, C12-15 alkyl benzoate, Cyclopentasiloxane, Glyceryl stearate, Cetyl alcohol, Dimethicone, Petrolatum, Paraffinum liquidum (Mineral oil), Mica, PEG-100 stearate, Cyclohexasiloxane, C18-36 acid glycol ester, Phenoxyethanol, Methylparaben, Sodium stearoyl lactylate, Polyacrylamide, Alumina, C13-14 isoparaffin, Tetrasodium EDTA, Laureth-7, BHT [+/- (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides)." ], "purpose": [ "Uses Provides moderate protection against adverse effects of the sun Higher SPF gives more protection." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . If swallowed get medical help." ], "questions": [ "USA: Questions? 1-866-75-BOOTS" ], "spl_product_data_elements": [ "No7 Soft and Sheer Tinted Moisturiser Medium Octinoxate and Titanium Dioxide OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER GLYCERIN BUTYLENE GLYCOL C12-15 ALKYL BENZOATE CYCLOMETHICONE 5 GLYCERYL MONOSTEARATE CETYL ALCOHOL DIMETHICONE PETROLATUM MINERAL OIL POLYOXYL 100 STEARATE CYCLOMETHICONE 6 PHENOXYETHANOL METHYLPARABEN TALC PROPYLPARABEN XANTHAN GUM ALUMINUM OXIDE C13-14 ISOPARAFFIN EDETATE SODIUM BUTYLATED HYDROXYTOLUENE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "Nicely natural... Add a little sheer colour while you gently care for your skin, with this soft and silky tinted moisturiser. It hydrates for 12 hours while light-reflecting particles help smooth the appearance of fine lines and flaws for a natural finish all day long. Dermatologically Tested www.boots.com", "Nicely natural... Add a little sheer colour while you gently care for your skin, with this soft and silky tinted moisturiser. It hydrates for 12 hours and evens out your complexion in one simple step, for a natural finish all day long. With light reflecting particles to help smooth the appearance of fine lines and flaws, plus Sunscreen SPF 15 to help protect your skin from the ageing effects of the sun. Ready to face the day... Shake before use. Smooth on evenly, just like your usual moisturiser. Dermatologically Tested." ], "warnings_and_cautions": [ "Warnings For external use only When using this product Avoid contact with eyes. If contact occurs rinse immediately with cold water." ], "ask_doctor": [ "Stop use and ask a doctor if rash or irritation develops and lasts." ], "openfda": {}, "version": "1", "storage_and_handling": [ "Other information Do not store above 30 0 C or 86 0 F" ], "information_for_patients": [ "Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford CT 06901", "www.boots.com Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford CT 06901 USA: Questions? 1-866-75-BOOTS" ], "package_label_principal_display_panel": [ "No7 Soft and Sheer Tinted Moisturiser Moisturises, protects and gives you a natural glow Sunscreen SPF 15 Hypo-allergenic Boots 50ml e 1.69 US Fl. Oz Soft and Sheer Tinted Moisturiser carton.jpg Soft and Sheer Tinted Moisturiser carton", "No7 Soft and Sheet Tinted Moisturiser All Skin types Sunscreen SPF 15 Hypo-allergenic Boots 50ml e 1.69 US Fl. Oz Soft and Sheer Tinted Moisturiser tube.jpg Soft and Sheer Tinted Moisturiser tube" ], "indications_and_usage": [ "Directions Shake before use. Smooth on evenly, just like your usual moisturiser. Apply evenly at least 15 minutes before sun exposure. Reapply as needed. Not intended for children under the age of 12. Not intended for protection while sunbathing." ], "set_id": "00ef44c2-3acf-4d31-93b6-fa6e50699cd5", "id": "4939ae99-6e9f-4b63-adc6-2bec3a92151b", "active_ingredient": [ "Active Ingredients Purpose Octinoxate 5% Sunscreens Titanium Dioxide 1.9%", "Tube label Active Ingredients: Octinoxate 5% Titanium Dioxide 1.9%" ] }, { "effective_time": "20111217", "inactive_ingredient": [ "I nactive Ingredients sucrose, calcium carbonate, corn starch, talc, mineral oil, calcium sterate, natural flavor and artificial flavor, adpic acid, Yellow No. 5, Yellow No. 6, Red No. 6, Red No. 30, Red No. 27 and Blue No. 1" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs" ], "when_using": [ "When using this product -do not take more than 15 tablets in 24 hours -do not use the maximum dosage for more than 2 weeks" ], "questions": [ "Questions? 1-877 2198302" ], "spl_product_data_elements": [ "CALCID ANTACID CALCIUM SUPPLEMENT REGULAR STRENGTH Calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION SUCROSE STARCH, CORN TALC MINERAL OIL CALCIUM STEARATE ADIPIC ACID FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 D&C RED NO. 6 D&C RED NO. 30 D&C RED NO. 27 FD&C BLUE NO. 1 mixed fruit Tablet CALCID orange, yellow, red" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Antacid -chew 2-4 tablets as symptoms occur or as directed by a doctor" ], "spl_unclassified_section": [ "Other information - for calcium content see Supplement Facts. - Store below30°C (86°F) - do not use if printed seal under cap is torn or missing CALCIUM SUPPLEMENT Uses: As a daily source of extra calcium Directions: chew 2 tablets twice daily with meal Supplement Facts Serving Size: 2 Tablets Servings Per Container: 50 Amount %Daily Per Serving Value Calories 5 Sugars 1g Calcium 400mg 40%" ], "package_label_principal_display_panel": [ "Package Label image of package label" ], "indications_and_usage": [ "Uses relieves: heartburn, sour stomach, acid indigestion, upset stomach associated with these symptoms" ], "set_id": "011bf4be-5e8c-47ae-9fbd-2b01da32696a", "id": "bd78021d-079f-4bfb-bfce-efff02835f00", "active_ingredient": [ "Active Ingredient (per tablet) Calcium carbonate USP 500 mg" ] }, { "effective_time": "20130826", "inactive_ingredient": [ "INACTIVE INGREDIENTS: TALC . MICA . NYLON-12 . DIMETHICONE . DIISOSTEARYL MALATE . OCTYLDODECYL STEAROYL STEARATE . SILICA . PHENYL TRIMETHICONE . PHENOXYETHANOL HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER . TOCOPHERYL ACETATE . SODIUM DEHYDROACETATE . PARAFFINUM LIQUIDUM/MINERAL OIL . METHICONE . DISODIUM EDTA . BORON NITRIDE . PARFUM/FRAGRANCE . HYDROGEN DIMETHICONE . LAUROYL LYSINE . SORBITAN SESQUIOLEATE . BUTYLENE GLYCOL . AQUA/WATER . HYDROXYETHYL UREA . CAMELLIA SINENSIS LEAF EXTRACT . ALGIN . ACACIA SENEGAL GUM. ± / MAY CONTAIN/PEUT CONTENIR : [CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/IRON OXIDES . CI 77007/ULTRAMARINES . CI 19140/YELLOW 5 LAKE]." ], "warnings": [ "WARNING: for external use only, not to be swallowed." ], "when_using": [ "Avoid contact with eyes." ], "spl_product_data_elements": [ "EVERLASTING COMPACT FOUNDATION SPF 15 TINT 105 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE TALC MICA DIMETHICONE OCTYLDODECYL STEAROYL STEARATE SILICON DIOXIDE PHENYL TRIMETHICONE PHENOXYETHANOL SODIUM DEHYDROACETATE MINERAL OIL EDETATE DISODIUM BORON NITRIDE LAUROYL LYSINE SORBITAN SESQUIOLEATE BUTYLENE GLYCOL WATER HYDROXYETHYL UREA GREEN TEA LEAF ACACIA FERRIC OXIDE RED" ], "description": [ "ATTENTION : usage externe uniquement 15 hours of impeccable hold and total comfort thanks to a new generation powder foundation. The soft, silky texture smoothes and evens the complexion for a naturally flawless finish. Apply with a dry or damp sponge. Matte finish - Adjustable coverage - All skin types. Anti-pollution protection. Non-comedogenic. Allergy tested. SPF 15. Distrib. Canada: CLARINS CANADA Inc. 815 Desserte est Autoroute Chomedey LAVAL (QUEBEC) H7W 5N4. ref. 402421 Emplacement Code Barres Bar code space MFD FOR CLARINS PARIS 92200 Neuilly 95300 Pontoise - France Made in Italy" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "DIRECTIONS: Apply liberally. Reapply as needed." ], "stop_use": [ "Discontinue use if signs of irritation or rash appear." ], "package_label_principal_display_panel": [ "Everlasting Compact Foundation SPF 15 - Kompakt Foundation SPF 15 - Kompakt foundation der holder og holder SPF 15 - Meikkipuuteri SPF 15 CLARINS S.A. 4, rue Berteaux-Dumas - 92200 Neuilly - France - T. + 33 (0)1 47 38 12 12 www.clarins.com CLARINS, LE MAQUILLAGE QUI PREND SOIN DE VOTRE PEAU Teint Compact Haute Tenue SPF 15 Everlasting Compact Foundation CLARINS: MAKE-UP THAT CARES FOR YOUR SKIN", "Everlasting Compact Foundation SPF 15 Clarins, the Skin Care Specialists, always offer foundations perfectly adapted to your skin's needs. Whatever the texture, level of coverage or shade, each formula is designed to deliver perfectly moisturized skin, a radiant complexion and a flawless finish. Everlasting Compact Foundation SPF 15 is perfect for women who want a foundation that delivers comfort and impeccable hold under any circumstances (stress, heat, humidity, etc.). - A perfect complexion for 15 hours: a new generation of powder foundation with a soft, silky texture, incorporates the \"High Fidelity System\" to guarantee perfectly even coverage and long-lasting hold. Colour pigments have a specific coating to protect them from sebum and perspiration, etc. Foundation stays put from morning to night and colour remains radiant. - Unrivalled radiance: the \"Light-Optimizing\" Complex, a Clarins exclusive, instantly captures, diffuses and magnifies the light. Fine lines and small imperfections are visibly minimized. The complexion appears even and luminous. - Optimal and continuous moisturization thanks to a plant ingredient that acts like a hydrating micro-patch. Your skin stays supple, hydrated and comfortable. - Triple protection: against free radicals, pollution and UV rays. Apply with either a dry sponge for a natural finish or a damp sponge for a more sophisticated look. Anti-pollution protection. Non-comedogenic. Allergy tested.", "105 nude Teint compact Haute Tenue SPF 15 Everlasting Compact Foundation Clarins PARIS 105 Teint Compact Haute Tenue SPF 15 Everlasting Compact Foundation e10 g 0.35 Oz. Net Wt.", "Teint Compact Haute Tenue 105 Booklet1", "Teint Compact Haute Tenue 105 Booklet 2", "Teint Compact Haute Tenue105", "Teint Compact Haute Tenue 105 Outer" ], "set_id": "0124872c-f2a1-43f4-85ec-b5ab6b2d6934", "id": "76f9e323-1337-486b-a61c-067bdc2f28f7", "active_ingredient": [ "" ] }, { "effective_time": "20100708", "inactive_ingredient": [ "Inactive Ingredients Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Gel, Sodium Acrylates Copolymer, Mineral Oil, Steareth 21, PPG 1 Trideceth, 6, Toco[heryl Acetate, Disodium EDTA, Methyl Salicylate, Thymol, Eucalyptol, Triethanolamine, Iodopropynyl Butylcarbamate, Diozolidinyl Urea" ], "purpose": [ "Use s For the temporary relief of pain and discomfort cause by - minor burns - sunburn - scrapes - insect bites - minor skin irritations - rashes due to poison ivy, oak and sumac" ], "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 - under bandages or compresses When using this product - avoid contact with the eyes Stop use and ask a doctor if condition worsens, or if symptoms persist for 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": [ "CVS Medicated Anti-Itch MENTHOL, PRAMOXINE HYDROCHLORIDE WATER STEARYL ALCOHOL PETROLATUM PROPYLENE GLYCOL PRAMOXINE HYDROCHLORIDE PRAMOXINE ALOE VERA LEAF TRIDECETH-6 STEARETH-21 STEARETH-2 THYMOL ALPHA-TOCOPHEROL METHYL SALICYLATE EDETATE DISODIUM DIAZOLIDINYL UREA TROLAMINE IODOPROPYNYL BUTYLCARBAMATE PROPYLENE GLYCOL EUCALYPTUS OIL MENTHOL MENTHOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions - Adults and children 2 years and older: apply to affected area not more than 2 tim - Children under 2 years of age: do not use, consult a doctor" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Use s For the temporary relief of pain and discomfort cause by - minor burns - sunburn - scrapes - insect bites - minor skin irritations - rashes due to poison ivy, oak and sumac" ], "set_id": "01447a2d-3a6a-4947-80cf-570b0a2941dd", "id": "c3d98a66-fe5d-4989-801b-31e58c563095", "active_ingredient": [ "Active ingredient Purpose Menthol 1%....................................................Anti-Itch Pain Relief Pramoxine Hydrochloride 1%............................Anti-Itch Pain Relief" ] }, { "effective_time": "20131213", "inactive_ingredient": [ "Inactive Ingredients Beeswax, Butyrospermum Parkii (Shea Butter), Ceresin, Euterpe Oleracea (Acai) Fruit Extract, Flavor, Hydrogenated Coconut Oil, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate (Vitamin A Palmitate), Sodium Ascorbyl Phosphate, Tocopheryl Acetate" ], "purpose": [ "Use Helps prevent sunburn" ], "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. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or Comments call 877-995-5405 www.lypsylhome.com or email customerservice @lornameadna.com" ], "spl_product_data_elements": [ "LypSyl Vanilla Plum Intense Protection Lip Balm OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE VITAMIN A PALMITATE ALPHA-TOCOPHEROL YELLOW WAX MINERAL OIL PETROLATUM SHEA BUTTER CERESIN PARAFFIN SODIUM ASCORBYL PHOSPHATE HYDROGENATED COCONUT OIL ACAI OXYBENZONE OXYBENZONE Vanilla Plum" ], "other_safety_information": [ "Other Information Protect this product from excessive heat and direct sun." ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "MM1.jpg MM2.jpg Carton Label Cylinder Label" ], "indications_and_usage": [ "Directions apply liberally 15 minutes before sun exposure after 40 minutes of swimming or sweating 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 Broad Spectrum SPF vlaue of 15 or higher and other sun protection measures including limit time in the sun, especially from 10a.m. -2 p.m. wear long-sleeved shirts, pants hats and sunglasses" ], "set_id": "014c36b5-bbb7-4e65-b42e-33a6af197474", "id": "2771ef5a-bde4-46b0-8a8c-d4c5d0b807ed", "active_ingredient": [ "Active Ingredients Octyl Methoxycinnamate 5.5%...................................Sunscreen Octylcrylene 2.0%....................................................Sunscreen Oxybenzone 3.5%....................................................Sunscreen Avobenzone 3.0%.....................................................Sunscreen" ] }, { "effective_time": "20140609", "inactive_ingredient": [ "Talc, Mica(CI 77019), Silica(CI 77811), Hexyl Laurate, Dimethicone, Diisostearyl Malate, Mineral Oil, Phenyl Trimethicone, Squalane, Iron Oxides(CI 77492), Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol Stearate, Fragrance, Iron Oxides(CI 77491), Ultramarines(CI 77007), Methylparaben, Iron Oxides(CI 77499), Propylparaben, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Silk, Tocopheryl Acetate, Macadamia Integrifolia Seed Oil" ], "instructions_for_use": [ "After applying make-up base or liquid foundation, put appropriate amount on a puff and tap lightly on face for even application." ], "warnings": [ "Avoid application to wounded or infected area. Do NOT use if irritation develops. If so, consult a physician immediately. Keep out of reach of children. Cover lid after each use. Store at a cool, dry place, away from direct sunlight. Instantly rinse with cold water when product comes in contact with eye(s)." ], "spl_product_data_elements": [ "Impact Fix Prism Two Way Cake SPF 24, No. 33 Titanium Dioxide, Zinc Oxide, Octinoxate TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION OCTINOXATE OCTINOXATE TALC MICA SILICON DIOXIDE HEXYL LAURATE FERRIC OXIDE YELLOW DIMETHICONE MINERAL OIL DIISOSTEARYL MALATE PHENYL TRIMETHICONE SQUALANE FERROSOFERRIC OXIDE LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER METHICONE (20 CST) FERRIC OXIDE RED DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) METHYLPARABEN PROPYLPARABEN JOJOBA OIL ALPHA-TOCOPHEROL ACETATE MACADAMIA OIL" ], "other_safety_information": [ "Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating." ], "openfda": {}, "version": "2", "package_label_principal_display_panel": [ "Package & product & refill front image Package & product & refill back image" ], "indications_and_usage": [ "Not only will it help prevent sunburn, it also reduces the risk of skin cancer and early skin aging if used as directed with other sun protection measures. (SPF value of 15 or higher)" ], "set_id": "016e4800-3ee2-47cd-8859-4e4a70a13ac2", "id": "a6a996bd-3f31-4ed8-a168-ebbb70804b9e" }, { "effective_time": "20130423", "inactive_ingredient": [ "Other ingredients: Water, Almond Oil, Glycerin, Cetearyl alcohol, Cetearteh-12, Mineral Oil, L-Carnitine, DMAE bitartrate, Sodium Ascorbyl Fosphate, Carbomer, Green Tea extract, Coffe Berry extract, Trietanolamine, Sodium Lauryl Sulphate, Vitamin C, Pepermint Oil, Menthol, Almond scent, Green Tea scent, Coco scent, EDTA disodium." ], "purpose": [ "Uses: protects from minor skin irritations. temporarily protects injured or exposed skin slows the loss of water of the skin by forming a barrier on the skin's surface enhances the appearance of dry or damaged skin increases the water content of the top layers of the skin is a lubricant for the surface of the skin gives skin a soft and smooth appearance" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings: For external use only when using this product skin irritation may occur some medicines may interact with dimethicone, however, no specific interactions are known at this time Do not use if you are allergic to any ingredients listed if you have sensitive skin and/or are sensitive to Dimethicone do not use if you are pregnant, planning to become pregnant, or breast feeding if you have an open wound, burn, damaged or irritated skin When using this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling should irritation occur lessen frequency of use avoid unnecessary sun exposure and use a 45 SPF sun screen when going outside Stop use and ask a doctor if any of these severe side effects occur: allergic reaction, irritation become severe i.e. persistant rash, hives, itching, burning, difficulty breathing, swelling" ], "spl_product_data_elements": [ "Simply Firm - Face and Neck Non Surgical Face Lift Dimethicone DIMETHICONE DIMETHICONE GLYCERIN CETYL ALCOHOL CETEARETH-12 MINERAL OIL LEVOCARNITINE DEANOL SODIUM ASCORBYL PHOSPHATE GREEN TEA LEAF COFFEE BEAN TROLAMINE SODIUM DODECYLBENZENESULFONATE ASCORBIC ACID PEPPERMINT OIL MINT ALMOND MELISSA OFFICINALIS COCOA EDETIC ACID METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE BUTYLATED HYDROXYANISOLE SUNFLOWER OIL WATER POMEGRANATE SEED OIL CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)" ], "openfda": {}, "version": "7", "dosage_and_administration": [ "3 fl oz / 119 mL" ], "package_label_principal_display_panel": [ "label image" ], "indications_and_usage": [ "Directions: cleanse gently apply SIMPLY FIRM BODY massage into desired area using long upward strokes start with a single application, gradually increase to as many applications as desired when going outside be sure to use a 45 SPF SUN SCREEN applicable to the area if excessive irritation or sensitivity develops stop use of product and contact a physician" ], "set_id": "019bf296-8fe3-473e-adea-26463820b630", "id": "f1525fc3-925b-44f9-a654-ef41076af283", "active_ingredient": [ "Active Ingredient Purpose Dimethicone 1% ............. skin protectant" ] }, { "effective_time": "20131011", "inactive_ingredient": [ "corn starch, croscarmellose sodium, Hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide" ], "purpose": [ "PURPOSE Pain Reliever Uses: For the temporary relief of minor aches and pains due to: headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor." ], "keep_out_of_reach_of_children": [ "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." ], "warnings": [ "WARNINGS Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction, which may include, hives, facial swelling, shock, asthma (wheezing) Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed." ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN STARCH, CORN CROSCARMELLOSE SODIUM HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MINERAL OIL TITANIUM DIOXIDE MICRO COATED CLEAR TCL;011" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Drink a full glass of water with each dose Adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last Do not take more than 12 tablets in 24 hours unless directed by a doctor. Children under 12 years: consult a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL MANUFACTURED BY: Time-Cap Labs, Inc Farmingdale, NY 11735 Repackaged & Relabeled by: Apotheca, Inc Phoenix, AZ 85006 Repackaged & Relabeled for: RejuviLife Phoenix, AZ 85006 NDC 12634-120-74 ASPIRIN ANALGESIC PAIN RELIEVER REJUVILIFE 24 TABLETS 325 MG (5 GR EACH) ASPIRIN" ], "indications_and_usage": [ "USES Provides temporary relief of headache pain and fever of colds muscle pain toothache menstrual pain minor pain of arthritis." ], "set_id": "01cdc525-f51f-4779-9e3b-01a35dd3bcac", "id": "9e5f53d8-1f64-4021-8b6e-7f74694919ab", "active_ingredient": [ "ACTIVE INGREDIENT Each tablet contains Aspirin 325 mg Aspirin (Acetysalicylic Acid) 325 mg (5gr.) (NSAID)*" ] }, { "effective_time": "20120213", "inactive_ingredient": [ "Inactive ingredients citric acid, fragrance, glycol stearate, hydroxyethylcellulose, lanolin alcohol, lauramide DEA, mineral oil, PEG-80 hydrogenated glyceryl palmate, petrolatum, sodium benzoate, sodium hydroxide, sulfonate 200, water." ], "purpose": [ "Purpose Surgical Hand Scrub" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed or gets in eyes, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only. Do not use if redness or irritation occurs. When using this product avoid contact with eyes. Stop use and ask a doctor if severe adverse reactions occur. Keep out of reach of children. If swallowed or gets in eyes, get medical help or contact a Poison Control Center immediately." ], "when_using": [ "When using this product avoid contact with eyes." ], "questions": [ "Questions? 1-800-453-4538 Monday to Friday, 8 a.m. to 5 p.m. M5T" ], "spl_product_data_elements": [ "BD E-Z Scrub Choroxylenol Chloroxylenol Chloroxylenol citric acid monohydrate glycol stearate hydroxyethyl cellulose (2000 MPA.S at 1%) lanolin alcohols lauric diethanolamide mineral oil hydrogenated palm glycerides petrolatum sodium benzoate sodium hydroxide entsufon sodium water" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Clean under nails with nail pick Wet hands and forearms Scrub thoroughly for 3 minutes paying particular attention to the nails, cuticles and interdigital spaces Rinse thoroughly Repeat scrub for 3 more minutes Rinse thoroughly" ], "spl_unclassified_section": [ "Drug Facts", "Other information avoid excessive heat 40°C (104°F) discard after single use." ], "stop_use": [ "Stop use and ask a doctor if severe adverse reactions occur." ], "do_not_use": [ "Do not use if redness or irritation occurs." ], "package_label_principal_display_panel": [ "Principal Display Panel – Box Label BD BD E-Z Scrub ™ 408 Surgical Scrub Brush/Sponge With 3% Chloroxylenol, Emollients and Nail Cleaner Ultradex ™ CONTAINS: 30 NOTE: SEE BACK PANEL FOR EASY INSTRUCTIONS Remove to check level of contents Reorder When Brushes Reach This Level. REF 374081 NDC 17271-408-10 REMOVE FOR CONVENIENT DISPENSING OF PRODUCT SEE REVERSE SIDE FOR EASY MOUNTING INSTRUCTIONS Principal Display Panel – Box Label" ], "indications_and_usage": [ "Use preoperative cleaning of healthcare personnel arms and hands. Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery." ], "set_id": "02431db6-a501-4608-938a-4b35323cc96e", "id": "eb35a5d9-ba77-4ddb-8099-5f7a4b9c5f54", "active_ingredient": [ "Active ingredient 3% (525mg) Chloroxylenol (PCMX) w/w" ] }, { "effective_time": "20121027", "inactive_ingredient": [ "Inactives. Inactive ingredients Aqua (Water), C12-15 alkyl benzoate, Glycerin, Butylene glycol, Cyclopentasiloxane, Mica, Glyceryl stearate, Petrolatum, Paraffinum liquidum (Mineral oil), Dimethicone, Cetearyl alcohol, PEG-100 stearate, Cyclohexasiloxane, Tribehenin, Rosa moschata seed oil, Phenoxyethanol, Alcohol denat., Methylparaben, Sodium stearoyl lactylate, Ascorbyl glucoside, Polacrylamide, Xanthan gum, Ethylparaben, Sodium polacrylate, C13-14 iosparaffin, Sodium hyaluronate, Tetrasodium ETA, Potassium hydroxide, Laureth-7, Dimethylmethoxy chromanol, Phyllanthus emblica fruit extract, Ceramide 3, Ginkgo biloba leaf extract, Ascorbyl palmitate, (+/- (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides)." ], "purpose": [ "Purpose section Uses helps prevent sunburn" ], "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 a Poison Control Center right away." ], "questions": [ "Questions. USA: Questions? 1-866-75-BOOTS." ], "spl_product_data_elements": [ "No7 Dual Action Tinted Moisturiser Medium Avobenzone, Octisalate and Octocrylene AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER C12-15 ALKYL BENZOATE GLYCERIN BUTYLENE GLYCOL CYCLOMETHICONE 5 MICA GLYCERYL MONOSTEARATE PETROLATUM MINERAL OIL DIMETHICONE CETOSTEARYL ALCOHOL PEG-100 STEARATE CYCLOMETHICONE 6 TRIBEHENIN ROSA MOSCHATA SEED OIL PHENOXYETHANOL METHYLPARABEN SODIUM STEAROYL LACTYLATE ASCORBYL GLUCOSIDE POLYACRYLAMIDE (1300000 MW) XANTHAN GUM ETHYLPARABEN SODIUM POLYACRYLATE (8000 MW) C13-14 ISOPARAFFIN HYALURONATE SODIUM EDETATE SODIUM TETRAHYDRATE POTASSIUM HYDROXIDE LAURETH-7 PHYLLANTHUS EMBLICA FRUIT JUICE CERAMIDE 3 GINKGO BILOBA LEAF OIL ASCORBYL PALMITATE TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERRIC FERROCYANIDE" ], "description": [ "Description. Beautiful Protection. Achieve natural, skin perfecting colour with this sheer, light diffusing, tinted moisturiser. It delivers all day hydration and a powerful antioxidant complex to defend your skin from the ageing effects of the sun and the environment. For Best Results: Shake well before use. Smooth on evenly, just like your usual moisturiser. Hypo-allergenic: Because all skin can have sensitive moments, all our foundation products are hypo-allergenic using ingredients we know and trust.", "Description. Beautiful Protection. Achieve natural, skin perfecting colour with this sheer, light diffusing tinted moisturiser. It delivers all day hydrtion and a powerful antioxidant complex to defend your skin from the ageing effects of the sun and the environment. For Best Results: Shake well before use. Smooth on evenly, just like your usual moisturiser." ], "warnings_and_cautions": [ "Warnings. Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse wither water to remove.", "Warnings. Warning: Avoid contact with eyes. If product gets into the eyes rinse well with water immediately." ], "ask_doctor": [ "Ask Doctor. Stop use and ask a doctor if rash occurs." ], "openfda": {}, "version": "1", "storage_and_handling": [ "Storage. Other information protect the product in this ocntainer from excessive heat and direct sun." ], "information_for_patients": [ "Information for patients. The Boots Company PLC Nottingham England NG2 3AA Dist by Boots Retail USA Inc Norwalk CT 06851 USA Made in France www.boots.com .", "Information for patients. The Boots Company PLC Nottingham England NG2 3AA Dist by Boots Retail USA Inc Norwalk CT 06851 USA Made in France www.boots.com ." ], "package_label_principal_display_panel": [ "carton label. carton label carton label" ], "indications_and_usage": [ "Indications. Directions apply liberally 15 minutes bfore sun exposure reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: 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." ], "set_id": "02e2d98f-e49e-4ff4-a95a-a085da3cfbdd", "id": "aee6a64c-183b-4dc4-b9b6-de9e98fbdc59", "active_ingredient": [ "active ingredients Drug Facts Active Ingredients Avobenzone 3%, Octisalate 2%, Octocrylene 4% Purpose Sunscreen", "Jar front and active ingredients. No7 Dual Action Tinted Moisturiser Sunscreen Broad Spectrum SPF 15 All skin types Long lasting hydration, environmental protection and beautiful sheer colour Hypo-allergenic 50ml 1.6 US Fl Oz Active ingredients: Avobenzone 3%, Octisalate 2%, Octocrylene 4%." ] }, { "effective_time": "20110901", "inactive_ingredient": [ "aloe barabardensis leaf Juice , water , mineral oil , glyceryl stearate , PEG-100 stearte , cetyl alcohol , cetearyl alcohol, polysorbate 60 , propylene glycol, stearic acid , hydrogenated polyisobutene, dimethicone, triethanolamine , salicylic acid, imidazolidinyl urea, chondrus crispus (carrageenan) , methylparaben, propylparaben,mentha piperita (peppermint oil), chloroxylenol, dmdm hydantoin" ], "purpose": [ "Purpose : External Analgesic" ], "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 right away." ], "warnings": [ "Warnings: For external use only ." ], "spl_product_data_elements": [ "Miracle Foot Repair Menthol MENTHOL MENTHOL ALOE VERA LEAF Water MINERAL OIL Stearic Acid PEG-100 STEARATE GLYCERYL MONOSTEARATE CETOSTEARYL ALCOHOL POLYSORBATE 60 PROPYLENE GLYCOL Cetyl Alcohol COCOA BUTTER TROLAMINE SALICYLIC ACID CHONDRUS CHAMOMILE Methylparaben Propylparaben DMDM HYDANTOIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions : adults and children 2 years and older apply as needed under 2 years ask a doctor. wash and dry skin apply liberatly over attached area and massage until absorbed ." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses: Temporary protects and helps relieve chapped or cracked skin" ], "set_id": "033c4d3c-8ad8-4d37-b700-c2557805bba8", "id": "42072e37-eb03-4d14-a0c8-b80adb46832f", "active_ingredient": [ "Active Ingredient : MENTHOL 0.1% Image of Tube" ] }, { "effective_time": "20130221", "inactive_ingredient": [ "Inactive Ingredients Mineral Oil, Calcium Silicate, Laureth-4, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract" ], "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 this product Do not get into eyes To avoid slipping use mat in tub or shower In some skin conditions, soaking too long may overdry 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." ], "when_using": [ "When using this product Do not get into eyes To avoid slipping use mat in tub or shower In some skin conditions, soaking too long may overdry" ], "questions": [ "Questions? Call 1-800-720-3843 Weekdays, 8AM – 8PM EST" ], "spl_product_data_elements": [ "Desitin Soothing Rash Bath Treatment Oatmeal Oatmeal Oatmeal Mineral Oil Calcium Silicate Laureth-4 Aloe Vera Leaf" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions For dispersal in water: Turn warm water faucet on to full force Slowly sprinkle packette of colloidal oatmeal directly under faucet into the tub or container Stir any colloidal oatmeal settled on the bottom For use as a soak in a bath: Slowly sprinkle one packette in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom. Soak affected area for 15 to 30 minutes as needed, or as directed by a doctor Pat dry (do not rub) to keep a thin layer on the skin." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "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." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 106 g Carton NEW #1 CHOICE OF PEDIATRICIANS & MOMS Desitin ® Soothing Rash Bath Treatment COLLOIDAL OATMEAL – SKIN PROTECTANT SOOTHES DIAPER AREA FRAGRANCE FREE ALLERGY TESTED 5 BATH PACKETS / TOTAL NET WT 3.75 OZ (106g) Principal Display Panel - 106 g Carton" ], "indications_and_usage": [ "Uses Temporary protects and helps relieve minor skin irritation and itching due to: Rashes" ], "set_id": "03728f02-86e3-4f03-97be-60593db35d42", "id": "d1f3980e-f7bf-4ca9-845e-21253aee659e", "active_ingredient": [ "Active ingredient Colloidal Oatmeal (43%)" ] }, { "effective_time": "20110216", "inactive_ingredient": [ "Inactive ingredients cod liver oil (contains vitamin A and vitamin D) daucus carota (carot) seed oil, fragrance, microcrystalline wax, mineral oil, paraffin" ], "purpose": [ "Active ingredient Purpose Lanolin 15.5% ..................................................Skin protectant Petrolatum 53.4%.............................................Skin protectant Uses - Helps treat and prevent diaper rash - temporarily protects minor - cuts - scrapes - burns - temporarily protects and helps relieve chapped, chafed or cracked skin and lips - helps protect from the drying effects of wind and cold weather" ], "keep_out_of_reach_of_children": [ "Keep out of the 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: - deep or puncture wounds - animal bites - serious burns When using this product - 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": [ "PETROLATUM and LANOLIN PETROLATUM and LANOLIN PETROLATUM PETROLATUM PARAFFIN MICROCRYSTALLINE WAX MINERAL OIL COD LIVER OIL CARROT SEED OIL LANOLIN LANOLIN" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions - for skin protectant use: apply as needed - For diaper rash use: - change wet and soiled diapers promptly - cleanse the diaper area and allow to dry - apply ointment liberally as often as necessarry with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged Other information Store between 15 degrees - 30 degrees C (59 degrees - 86 degrees F)" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Uses - Helps treat and prevent diaper rash - temporarily protects minor - cuts - scrapes - burns - temporarily protects and helps relieve chapped, chafed or cracked skin and lips - helps protect from the drying effects of wind and cold weather" ], "set_id": "0453b2fe-a66d-4fa5-bdd4-ba61a9eb7b15", "id": "f399a188-ccc2-46c2-9994-75d183475c67", "active_ingredient": [ "Active ingredient Purpose Lanolin 15.5% ..................................................Skin protectant Petrolatum 53.4%.............................................Skin protectant" ] }, { "effective_time": "20111112", "inactive_ingredient": [ "Inactive ingredients Deionized Water, Cyclomethicone, Mineral Oil, Lauryl PEG/PPG-18/18 Methicon, Cetyl dimethicone, Stearyl Dimethicone, Ceresine, Hydrogenated Castor Oil, Plankton extract, Propylene Glycol, Diazolidinyl Urea, Propylparaben, Methylparaben, Lanthanum Chloride, Magnesium Chloride, Sodium Citrate, Tetrasodium EDTA, Trimethoxycaprylylsilane, Glycoproteins, Glycosaminoglycans, Fragrance, Calcium Chloride." ], "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 a Poison Control Center Immediately." ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warning - For external use only." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15 OCTINOXATE, ZINC OXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC WATER CYCLOMETHICONE MINERAL OIL SODIUM DICHLOROACETATE HYDROGENATED CASTOR OIL PROPYLENE GLYCOL DIAZOLIDINYL UREA PROPYLPARABEN METHYLPARABEN MAGNESIUM CHLORIDE SODIUM CITRATE EDETATE SODIUM TRIMETHOXYCAPRYLYLSILANE CALCIUM CHLORIDE" ], "description": [ "Description SAFE SEA Sunscreen SPF 15 With Jellyfish Sting Protective Lotion The world's only sunscreen lotion scientifically developed to help prevent the stings from most jellyfish*, Sea nettle, Sea lice (Seabathers eruption). Dermatologist tested. UVAandUVB protection For sensitive skin. Water resistant. Distributed by Nidaria Technology ltd. 420 Lexington Avenue Suite 2400 New York, New York 10170 Made in Israel. www.nidaria.com US Patents No. 6338837 / 6406709 / 6132747 NDC - 0654350115 7 13026 10115 5" ], "other_safety_information": [ "Other Information - Give particular attention to coverage of arms and legs. - In water infested by Sea Lice, Safe Sea should also be applied under the bathing suit. Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings. - In case of sting do not use Safe Sea as a treatment - seek medical attention. * Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) and Rhopilema. Date on file." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - Adults and children six months of age and older. Apply Liberally to all exposed areas 10 minutes before sun or water exposure. - Ensure complete coverage. - Reapply after prolonged swimmimg and towel drying." ], "stop_use": [ "Stop use and ask a doctor if skin irritation or rash develops." ], "package_label_principal_display_panel": [ "SAFE SEA Sunscreen SPF 15 With Jellyfish Sting Protective Lotion", "SAFE SEA Sunscreen with JELLYFISH STING PROTECTIVE LOTION SPF 15 Helps Prevent Stings from Jellyfish and Sea Lice UVA, UVB, Water Resistant Clinically Tested 4 fl. oz. (118 ml)", "Product Package Outer Label A Safe Sea SPF 15 A", "Product Package Outer Label B Safe Sea SPF 15 B" ], "indications_and_usage": [ "Uses - Helps prevent sunburn. - Sun Protection Factor 15. - Retains SPF after 80 minutes of activity in the water or perspiring." ], "set_id": "045ded38-5d0a-45b3-951f-a58ae3cf5516", "id": "fdb6b8cf-f655-47b6-8052-623a40d2ff2a", "active_ingredient": [ "Active Ingredients Active Ingredients Purpose Octinoxate 7.5 %, Zinc Oxide 2 %.............................Sunscreen" ] }, { "effective_time": "20140522", "inactive_ingredient": [ "Inactive ingredients: Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water" ], "purpose": [ "Purpose: Helps treat and prevent diaper rash Temporarily protects minor cuts scrapes and burns dries the oozing and weeping of poison ivy poison oak poison sumac" ], "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 in eyes." ], "spl_product_data_elements": [ "zinc oxide zinc oxide ZINC OXIDE ZINC OXIDE LANOLIN CETETH-10 MINERAL OIL PARAFFIN METHYLPARABEN PROPYLPARABEN SODIUM GLYCERIN PHENOXYETHANOL CETYL ALCOHOL STEARETH-20 POLYETHYLENE GLYCOL 6000 POLYSORBATE 60 CETOSTEARYL ALCOHOL CHOLECALCIFEROL VITAMIN A ALPHA-TOCOPHEROL ALOE VERA LEAF PETROLATUM TROLAMINE WATER" ], "openfda": {}, "version": "12", "dosage_and_administration": [ "Dosage and Administration: For skin protectant: Apply liberally as needed For diaper Rash: change wet and soiled diapers promptly allow to dry apply ointment liberally with each diaper change" ], "stop_use": [ "Stop use and ask a doctor if: condition worsens symptoms last more than 7 days or clear up and occur again in a few days, consult a physician" ], "spl_unclassified_section": [ "Other information: Store at room temperature avoid excessive heat contains color additives including FDC yellow # 5" ], "package_label_principal_display_panel": [ "Principal Display Panel Dynarex DynaShield Skin Protectant zinc_oxide.jpg zonc_oxide" ], "indications_and_usage": [ "Indications: For use as a general skin protectant and diaper rash." ], "set_id": "049b727b-6abd-410c-a5d8-7b9c0fdfdbeb", "id": "a137e963-1fa0-4772-a6a1-1d7a01bf1040", "active_ingredient": [ "Active Ingredient Purpose Zinc Oxide (1.8% w/w) Skin Protectant" ] }, { "effective_time": "20101006", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane Isopropyl Palmitate Stearyl Alcohol Mineral Oil Talc Hydrogenated Castor Oil Fragrance (Parfum) Steareth-100 BHT" ], "purpose": [ "Purpose anti-perspirant" ], "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" ], "questions": [ "Questions? Call 1-800-782-8301" ], "spl_product_data_elements": [ "Suave Cocoa Butter Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum cation CYCLOMETHICONE 5 ISOPROPYL PALMITATE Stearyl Alcohol HYDROGENATED CASTOR OIL TALC MINERAL OIL STEARETH-100 BUTYLATED HYDROXYTOLUENE" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "2.6 oz PDP Suave Cocoa Butter 2.6 oz PDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "04f337a9-d3be-4ce0-b0d6-8ed278f24a3c", "id": "29792d40-ae4c-4761-9d64-5f29c3508628", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (18.2%)" ] }, { "effective_time": "20100327", "inactive_ingredient": [ "Inactive Ingredients SD Alcohol 40-B, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Retinyl Palmitate (Vitamin A), Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Octyldodecanol, Silica, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Plumeria Acutifolia Flower Extract, Colocasia Antiquorum Root Extract, Psidium Guajava Fruit Extract, Passiflora Incarnata Fruit Extract, Mineral Oil, Aloe Barbadensis Leaf Extract, 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 Do not spray directly into face Flammable: do not use near heat, flame, or while smoking When using this product avoid spraying in eyes. If contact occurs, rinse thoroughly with water. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Stop use and ask a doctor if irritation or rash develops 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 spraying in eyes. If contact occurs, rinse thoroughly with water. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F." ], "questions": [ "Questions or Comments? Call 1-800-NO UV RAY, Mon-Fri Distributed by: TANNING RESEARCH LABORATORIES,LLC Ormond Beach, FL 32174 Made in U.S.A." ], "spl_product_data_elements": [ "Hawaiian Tropic Island Sport SPF 30 Avobenzone and Octocrylene and Oxybenzone AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE CAPRYLYL GLYCOL VITAMIN A PALMITATE ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE, D- OCTYLDODECANOL SILICON DIOXIDE PAPAYA MANGO PLUMERIA EXTRACT GUAVA PASSIFLORA INCARNATA TOP MINERAL OIL ALOE VERA LEAF" ], "description": [ "Purpose Sunscreen" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply generously and evenly to all areas 15 minutes before sun exposure spray on hands to apply to face use in well-ventilated area reapply at frequent intervals and after swimming or towel drying ask a doctor before use on children under six months of age" ], "spl_unclassified_section": [ "Drug Facts", "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. May stain some fabrics." ], "stop_use": [ "Stop use and ask a doctor if irritation or rash develops" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NEW HAWAIIAN Tropic ® ISLAND sport TM Clear Spray Sunscreen hydrates skin very water resistant skin-nourishing antioxidants 30 UVB/SPF WITH UVA SUNSURE Protection TM Protect Pamper Nourish 6 FL. OZ. (177 ml) PRINCIPAL DISPLAY PANEL Hawaiian Tropic Island Sport SPF 30" ], "indications_and_usage": [ "Use helps prevent sunburn" ], "set_id": "05c1ce43-131d-4663-b0b7-9dbac20bfea4", "id": "a4e3211d-f25b-4e3e-b39d-028de892f165", "active_ingredient": [ "Active Ingredients Avobenzone 0.01mL / 1mL Octocrylene 0.077mL / 1mL Oxybenzone 0.03mL / 1mL" ] }, { "effective_time": "20140509", "inactive_ingredient": [ "Inactive Ingredients Ozokerite, Mineral Oil, PEG-8, Lanolin, Microcrystalline Wax, Flavor, Paraffin Wax, Copernicia Cerifera (Carnauba) Wax, Sucralose, Aloe Barbadenis Leaf Extract, Tocopherol, Methylparaben, Propylparaben." ], "purpose": [ "Purpose Sunscreen, Sunscreen, 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 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 prevent sunburn, not skin cancer or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts." ], "spl_product_data_elements": [ "Zinka Watermelon SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE PETROLATUM PETROLATUM LIGHT MINERAL OIL MICROCRYSTALLINE WAX LANOLIN CERESIN PEG-8 STEARATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Zinka Watermelon SPF 15 Lip Balm" ], "indications_and_usage": [ "Uses Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips." ], "set_id": "05c2271c-88a5-4b9f-81c1-8fc17778005e", "id": "05c2271c-88a5-4b9f-81c1-8fc17778005e", "active_ingredient": [ "Active ingredient Octinoxate (7.5%), Oxybenzone (3.5%) Petrolatum (42%)" ] }, { "effective_time": "20150716", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients: TALC, ZEA MAYS (CORN) STARCH, POLYGLYCERYL-2 TRIISOSTEARATE, SILICA, MICA, IRON OXIDE(Cl 77492), DIMETHICONE, MINERAL OIL, IRON OXIDE(Cl 77491), IRON OXIDE(Cl 77499), MAGNESIUM MYRISTATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TOCOPHERYL ACETATE, PERFUME, PROPYLPARABEN, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, BUTYLPARABEN" ], "purpose": [ "PURPOSE Purpose: Sunscreen" ], "warnings": [ "WARNINGS Warnings: KEEP OUT OF EYES. STOP USING IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN." ], "spl_product_data_elements": [ "PERFECT SKIN PACT CARAMEL Titanium Dioxide Titanium Dioxide TITANIUM DIOXIDE TALC POLYGLYCERYL-2 TRIISOSTEARATE" ], "description": [ "DESCRIPTION ATTENTION: EVITER TOUT CONTACT AVEC LES YEUX. SUSPENDRE L’UTILISATION EN CAS D’IRRITATION. TENIR HORS DE PORTEE DES ENFANTS. ATENCION: EVITE QUE ENTRE EN LOS OJOS. INTERRUMPA SU USO SI SE PRODUCE IRRITACION. MANTENER FUERA DES ALCANCE DE LOS NINOS. How to use: APPLY AN ADEQUATE AMOUNT EVENLY OVER ENTIRE FACE." ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton" ], "set_id": "05dd8e90-4c91-44d9-9145-22f687187861", "id": "644dc914-e012-42f5-a2f2-fbe49bd4ff3b", "active_ingredient": [ "ACTIVE INGREDIENT Active Ingredient: Titanium Dioxide 17.17%" ] }, { "effective_time": "20130603", "inactive_ingredient": [ "Inactive Ingredients Beeswax, Butyrospermum Parkii (Shea Butter), Ceresin, Euterpe Oleracea (Acai) Fruit Extract, Flavor, Hydrogenated Coconut Oil, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate (Vitamin A Palmitate), Sodium Ascorbyl Phosphate, Tocopheryl Acetate" ], "purpose": [ "Use Helps prevent sunburn" ], "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. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or Comments call 877-995-5405 www.lypsylhome.com or email customerservice @lornameadna.com" ], "spl_product_data_elements": [ "LypSyl Vanilla Plum Intense Protection Lip Balm OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE VITAMIN A PALMITATE ALPHA-TOCOPHEROL YELLOW WAX MINERAL OIL PETROLATUM SHEA BUTTER CERESIN PARAFFIN SODIUM ASCORBYL PHOSPHATE HYDROGENATED COCONUT OIL ACAI OXYBENZONE OXYBENZONE Vanilla Plum" ], "other_safety_information": [ "Other Information Protect this product from excessive heat and direct sun." ], "openfda": {}, "version": "3", "package_label_principal_display_panel": [ "MM1.jpg MM2.jpg Carton Label Cylinder Label" ], "indications_and_usage": [ "Directions apply liberally 15 minutes before sun exposure after 40 minutes of swimming or sweating 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 Broad Spectrum SPF vlaue of 15 or higher and other sun protection measures including limit time in the sun, especially from 10a.m. -2 p.m. wear long-sleeved shirts, pants hats and sunglasses" ], "set_id": "062f1a78-177e-4922-b1fb-e06bea858eae", "id": "d48300f2-8599-47e9-8a1c-1e7c3dd826e7", "active_ingredient": [ "Active Ingredients Octyl Methoxycinnamate 5.5%...................................Sunscreen Octylcrylene 2.0%....................................................Sunscreen Oxybenzone 3.5%....................................................Sunscreen Avobenzone 2.0%.....................................................Sunscreen" ] }, { "effective_time": "20121018", "inactive_ingredient": [ "Inactive ingredients USP water, mineral oil, petrolatum, alcohol, glyceryl stearate, PEG-100 stearate, paraffin, cetyl alcohol, lecithin, essential oils, imidazolidinyl urea, methylparaben, propylparaben, triethanolamine" ], "purpose": [ "Purpose Skin protectant" ], "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 this product keep out of eyes. Do not use on deep wounds animal bites serious burns Stop use and ask a doctor if condition worsens symptoms lasts more than seven days or clear up and occur again within a few days 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." ], "spl_product_data_elements": [ "nanocare Dimethicone Dimethicone Dimethicone water mineral oil petrolatum alcohol glyceryl monostearate PEG-100 stearate paraffin cetyl alcohol imidurea methylparaben propylparaben trolamine" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to dry areas as needed children under 6 months: Ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Manufactured by: Dermazone Solutions, Inc. 2440 30th Avenue North St. Petersburg, FL 33713 USA Distributed by: Universal Sales & Marketing, Inc." ], "stop_use": [ "Stop use and ask a doctor if condition worsens symptoms lasts more than seven days or clear up and occur again within a few days" ], "do_not_use": [ "For external use only.", "Do not use on deep wounds animal bites serious burns" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Jar Label nanocare for skin Penetrating Moisturizing Cream with sealing barrier 4.0 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Jar Label" ], "indications_and_usage": [ "Uses helps prevent and relieve chafed or cracked skin" ], "set_id": "064b0238-ea0b-4c3b-a032-863be27205ad", "id": "0f895e98-07ff-42c9-9e2a-17f6e328dae5", "active_ingredient": [ "Active ingredients Dimethicone 1.0%" ] }, { "effective_time": "20150128", "inactive_ingredient": [ "Inactive ingredients Mineral Oil, Ceresin, Lanolin Alcohol" ], "purpose": [ "Uses Temporarily protects minor: • cuts • scrapes • burns • temporarily protects and helps relieve chapped or cracked skin and lips • helps protect from the drying effects of wind and cold weather" ], "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 When using this product do not get into eyes" ], "spl_product_data_elements": [ "Dry Skin Treatment Studio 35 PETROLATUM 41% PETROLATUM PETROLATUM Ceresin Lanolin Alcohols Mineral Oil" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions Apply as needed" ], "stop_use": [ "Stop use and ask doctor if Condition worsens, simptoms last more than 7 days or clear up and occur again within a few days" ], "spl_unclassified_section": [ "Other information Do not use if inner seal is broken or missing" ], "do_not_use": [ "Do not use on Deep or puncture wounds, animal bites, serious burns" ], "package_label_principal_display_panel": [ "label 14 oz label 1.75 oz" ], "indications_and_usage": [ "" ], "set_id": "076aa075-2c67-4a0d-8fd6-71a51c6e12af", "id": "e35f473f-020b-4c6a-b656-1c54bfb77768", "active_ingredient": [ "Active Ingredient Purpose Petrolatum 41% Skin protectant (ointment)" ] }, { "effective_time": "20141027", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane, Stearyl Alcohol, Mineral Oil, Hydrogenated Castor Oil, Cetyl Alcohol, Diisopropyl Adipate, Aluminum Starch Octenylsuccinate, Glyceryl Stearate (and) PEG-100 Stearate, Fragrance, Silica, PPG-14 Butyl Ether, Talc" ], "purpose": [ "Purpose Antiperspirant" ], "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 use in or near eyes apply to underarms only" ], "questions": [ "Questions? Call 1-800-331-0221" ], "spl_product_data_elements": [ "CERTAIN DRI AM SOLID Aluminum zirconium tetrachlorohydrex glycine Aluminum Zirconium Tetrachlorohydrex Gly Aluminum Cation Cyclomethicone 5 Stearyl Alcohol Mineral Oil Hydrogenated Castor Oil Cetyl Alcohol Diisopropyl Adipate Aluminum Starch Octenylsuccinate Glyceryl Monostearate Peg-100 Stearate Silicon Dioxide Ppg-14 Butyl Ether Talc CERTAIN DRI A.M. SOLID Label CERTAIN DRI A.M. SOLID Carton" ], "ask_doctor": [ "Consult a Doctor before use if you have kidney disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions remove product cover turn dial at bottom to raise product apply to underarms only" ], "stop_use": [ "Stop use and ask a doctor if rash or irritation develops" ], "do_not_use": [ "Do not use immediately after shaving on broken skin on irritated skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL All Day Freshness. A companion for Clinical Strength Certain Dri Roll-On or Solid To be used with CERTAIN DRI ® Anti-Perspirant EVERYDAY STRENGTH CERTAIN DRI A.M. ® SOLID Anti-Perspirant/Deordorant Goes on Clear Morning Fresh Scent 2.6 OZ. (74 g) Deodorant Anti-Perspirant Guaranteed Satisfaction If you are not completely satisfied, send us a copy of your cash register receipt, UPC code # along with your full name and address and we will replace or refund your purchase. Limit one refund per household. For further information, visit our website at www.certaindri.com CERTAIN DRI A.M. ® Solid Anti-Perspirant/Deodorant has been specially formulated as a companion to Clinical Strength CERTAIN DRI ® Anti-Perspirant 72hr protection Roll-on and Solid. Its odor system delivers additional everyday freshness and protection. Distributed by: DSE Healthcare Solutions, LLC. P.O. Box 6321, Edison, NJ 08818 1(800)331-0221 5004 Rev. 12/13 www.dsehealth.com THE CERTAIN DRI PROTECTION SYSTEM™ If you suffer from excessive perspiration, THE CERTAIN DRI PROTECTION SYSTEM™ offers complete underarm security and confidence under all situations: • At night to control excessive perspiration, use Clinical Strength CERTAIN DRI ® Anti-Perspirant, Roll-on or Solid. • In the morning for all day freshness and deodorant protection, use Everyday Strength CERTAIN DRI A.M. ® Anti-Perspirant/Deodorant. All Day Freshness A companion for Clinical Strength Certain Dri Roll-on or Solid EVERYDAY STRENGTH CERTAIN DRI A.M. ® SOLID Anti-Perspirant/Deodorant Goes on Clear Morning Fresh Scent NET WT 2.6 OZ (74 g) Distributed by: DSE Healthcare Solutions, LLC. Edison, NJ 08818 1(800)331-0221 5003 Rev. 2/14 Made in Canada www.dsehealth.com" ], "indications_and_usage": [ "Uses reduces underarm perspiration" ], "set_id": "07b2b0e3-d328-ca5b-5d36-45a6ecb9ce22", "id": "dc3e078d-84ef-46a8-9412-9f99233b476a", "active_ingredient": [ "Active ingredient Aluminum Zirconium Trichlorohydrex Glycine 20%" ] }, { "effective_time": "20151223", "inactive_ingredient": [ "Inactive ingredients Croscarmellose sodium, Dicalcium Phosphate, FD&C Yellow #5,Lake, FD&C Yellow #6 Lake, Hydroxypropylmethylcellulose, Magensium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Sodium Lauryl Sulfate, Starch, Stearic cid and Titanium Dioxide." ], "purpose": [ "Purpose" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poision Control Center right away." ], "warnings": [ "Warnings Do not use for longer than one week, when abdominal pain, nausea or vomiting are present." ], "spl_product_data_elements": [ "Senna Plus Senna Plus CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM ALUMINUM SILICATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOLS SODIUM BENZOATE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CPC490" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Take preferably at bedtime or as directed by a doctor, if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable age starting dose maximum dose adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day 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 you have rectal bleeding, you fail to have a bowel movement after use of this product, may indicate a serious condition. You may report side effects to FDA at 1-800-FDA-1088." ], "storage_and_handling": [ "Store at controlled room temperature 20°C to 25°C (68°-77°F), excursions permitted to 15°C to 30°C (598°-86°F). Mfg by Contract Pharmacal Corp Hauppauge, NY 11788 USA www.CPCHealth.com" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Senna Plus Carton Label" ], "indications_and_usage": [ "Uses For the short term relief of constipation, produce bowel movement in 6 to 12 hours." ], "set_id": "07beb7c7-af12-48a3-ae0f-fce96ce1fca8", "id": "2794d704-947c-195f-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks" ], "active_ingredient": [ "Active ingredient Sennosides form Senna Concentrate 8.6mg Sodium Dioctylsulfosuccinate 50 mg" ], "dosage_and_administration_table": [ "
age starting dose maximum dose
adults and children over 12 years 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor
" ] }, { "effective_time": "20120427", "inactive_ingredient": [ "Other Ingredients: D.I. Water, Emulsifying Wax, Caprylic/Capric Triglyceride, Propylene Glycol, Mineral Oil, Triethanolamine, Carbomer and Imidazolidinyl urea." ], "purpose": [ "Purpose **WR **WR **WR **WR" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "WARNING: for external use only Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water Keep out of reach of children If condition worsens or does not improve after regular use of this product as directed or if local irritation or rash occurs, discontinue use and consult a physician. Use only if seal is unbroken." ], "questions": [ "Other Information: Any Questions? 1-800-644-8327 Website: BotanicChoice.com" ], "spl_product_data_elements": [ "Homeopathic Wart Sulphide of antimony, potassium hydrate, woody nightshade, arbor vitae ANTIMONY TRISULFIDE ANTIMONY CATION (3+) CAUSTICUM CAUSTICUM SOLANUM DULCAMARA TOP SOLANUM DULCAMARA TOP THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG WATER CETOSTEARYL ALCOHOL POLYSORBATE 60 TRICAPRYLIN PROPYLENE GLYCOL MINERAL OIL TROLAMINE CARBOMER 934 IMIDUREA" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Apply to affected area twice daily" ], "spl_unclassified_section": [ "Drug Facts", "*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the U.S. **The letters WR indicate Wart Relief.", "Drug Facts (cont.)", "Distributed by: Indiana Botanic Gardens, Inc. 3401 W. 37th Avenue Hobart, IN 46342" ], "stop_use": [ "If condition worsens or does not improve after regular use of this product as directed or if local irritation or rash occurs, discontinue use and consult a physician." ], "package_label_principal_display_panel": [ "Homeopathic Wart Cream For the treatment of warts, birthmarks 1 oz. image of label" ], "indications_and_usage": [ "Uses: apply to the affected area for the treatment of warts or birthmarks" ], "set_id": "07e7444f-4b72-46b4-a4bb-af2d90ffa933", "id": "5abadf50-37ae-4fa7-aa36-84e194a69e1a", "active_ingredient": [ "Active Ingredients Sulphide of antimony 10X H.P.U.S.* Potassium hydrate 10X H.P.U.S.* Woody Nightshade 10X H.P.U.S.* Arbor Vitae 10X H.P.U.S.*" ] }, { "questions_table": [ "
NDC Strength Quantity/Form Color Source Prod. Code
53808-0834-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2030
" ], "effective_time": "20130911", "inactive_ingredient": [ "Inactive ingredients benzoic acid, carnauba wax, FD&C blue #1, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever Pain reliever Pain reliever aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tables in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask Doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis. or kidney disease you are taking a diuretic high blood pressure you have asthma Ask a doctor or pharmacist before use any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs os stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children Overdose Warning In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments 1-800-468-7746 This product is supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0834-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2030 This product was Manufactured By: Novartis Pharmaceuticals Corporation One Health Plaza And Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States" ], "spl_product_data_elements": [ "Excedrin Extra Strength Acetaminophen, Aspirin (NSAID), and Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE BENZOIC ACID CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE DIMETHICONE 410 FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE HYPROMELLOSE 2910 (15 MPA.S) LIGHT MINERAL OIL POLYSORBATE 20 POVIDONE PROPYLENE GLYCOL SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE White E" ], "ask_doctor": [ "Ask Doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis. or kidney disease you are taking a diuretic high blood pressure you have asthma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed (see Overdose Warning) drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tables in 24 hours children under 12 years: ask a doctor Other information store at controlled room temperature 20 0 - 25 0 C (68 0 - 77 0 F) read all product information before using. Keep this box for important information" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs os stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "Principal Display Panel Excedrin E.S. Tablets" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps" ], "set_id": "081ca362-bfd1-4eeb-b2a1-b47f05ee0e2f", "id": "afaee673-4a3b-4204-b20b-4dd229c26dfd", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition" ], "overdosage": [ "Overdose Warning In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20141016", "inactive_ingredient": [ "INGREDIENTS WATER (AQUA), CYCLOMETHICONE, TITANIUM DIOXIDE, MINERAL OIL (PARAFFINUM LIQUIDUM), DIPROPYLENE GLYCOL, ETHYLHEXYL METHOXYCINNAMATE, PETROLATUM, SORBITAN ISOSTEARATE, MALTITOL, TRIBEHENIN, HYDROGENATED CASTOR OIL HYDROXYSTEARATE, ACRYLATES COPOLYMER, NIACINAMIDE, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, PRUNUS ARMENIACA (APRICOT) JUICE, ALCOHOL, LAUROYL LYSINE, GLYCERIN, FRAGRANCE (PARFUM), SILICA, DIMETHOXY DI-p-CRESOL, METHYLSERINE, BHT, PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT, PYRACANTHA FORTUNEANA FRUIT EXTRACT, HYDROLYZED SILK, SORBIC ACID, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, [MAY CONTAIN(+/-)] BARIUM SULFATE (CI 77120), IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), TALC" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warning Stop use and ask a doctor if skin rash occurs. Keep out of reach of children." ], "spl_product_data_elements": [ "SENSAI CELLULAR PERFORMANCE FOUNDATION CF12 OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER CYCLOMETHICONE MINERAL OIL DIPROPYLENE GLYCOL PETROLATUM MALTITOL TRIBEHENIN HYDROGENATED CASTOR OIL NIACINAMIDE APRICOT ALCOHOL GLYCERIN SILICON DIOXIDE BUTYLATED HYDROXYTOLUENE SORBIC ACID METHYLPARABEN ETHYLPARABEN PROPYLPARABEN BUTYLPARABEN ISOBUTYLPARABEN TALC" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Apply liberally and evenly before sun exposure and as needed. Use helps prevent sunburn. Apply and reapply as directed to avoid lowering protection." ], "stop_use": [ "Stop use and ask a doctor if skin rash occurs." ], "spl_unclassified_section": [ "DIST.: Kanebo Cosmetics USA, Inc. 330 Madison Avenue, New York, NY 10017" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton SENSAI CELLULAR PERFORMANCE SPF 15 CREAM FOUNDATION FOND DE TEINT CRÈME Kanebo INTERNATIONAL NET WT. 1.01 OZ. 30mL e Principal Display Panel - 30 mL Jar Carton" ], "set_id": "08c0602a-9842-4a80-8b6b-6ed87c3f52c7", "id": "aea6b519-e06c-4cf3-8de2-4e7fa847d178", "active_ingredient": [ "ACTIVE INGREDIENTS OCTINOXATE 3.0% Sunscreen TITANIUM DIOXIDE 5.0% Sunscreen" ] }, { "effective_time": "20130104", "inactive_ingredient": [ "Inactive Ingredients Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta" ], "purpose": [ "Purpose Anti-itch" ], "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 do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator" ], "spl_product_data_elements": [ "BudPak Anti-Itch Hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER MINERAL OIL PROPYLENE GLYCOL CETOSTEARYL ALCOHOL PETROLATUM GLYCERYL MONOSTEARATE POLYSORBATE 60 SORBITAN MONOSTEARATE METHYLPARABEN PROPYLPARABEN EDETATE SODIUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions for itching of skin irritation, inflammation, and rashes: 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: Ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: Ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs" ], "spl_unclassified_section": [ "Other information Store at room temperature Lot No. & Exp. Date:see crimp of tube", "PRINCIPAL DISPLAY PANEL BUDPAK ANTI-ITCH CREAM Hydrocortisone 1% NET WT 0.5 OZ. (14 g)" ], "do_not_use": [ "Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Ask a doctor." ], "package_label_principal_display_panel": [ "image of package label" ], "indications_and_usage": [ "Uses for the temporary relief of itching associated with minor skin irritations and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, oak, sumac soaps detergents cosmetics jewelry external genital, feminine and anal itching Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor." ], "set_id": "0a67e5e7-fc2e-445e-a5c6-03d07c91f29c", "id": "1d91f27f-8cf0-4af1-a049-c74835d6859b", "active_ingredient": [ "Active Ingredient Hydrocortisone 1%" ] }, { "effective_time": "20120731", "inactive_ingredient": [ "I n active ingredients cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin" ], "purpose": [ "Purpose Oral pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics" ], "questions": [ "Questions or comments? call s at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com" ], "spl_product_data_elements": [ "Baby Orajel Nighttime Instant Relief for Teething Pain Long Lasting Extra Strength Benzocaine BENZOCAINE BENZOCAINE CARBOXYMETHYLCELLULOSE SODIUM MINERAL OIL GELATIN PECTIN PETROLATUM POLYETHYLENE GLYCOLS FD&C RED NO. 40 SACCHARIN SODIUM DIHYDRATE Cherry Flavored" ], "ask_doctor": [ "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness does not go away swelling, rash or fever develops" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions wash hands cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Baby Orajel apply to the affected area up to 4 times daily or as directed by a dentist or doctor for infants under 4 months, ask a dentist or doctor Other information do not use if tube tip is cut prior to opening." ], "do_not_use": [ "do not use more that directed for more than 7 days unless directed by a dentist or doctor When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persists, consult your doctor." ], "package_label_principal_display_panel": [ "Principal Display Panel No. 1 TEETHING BRAND used by Pediatricians Baby Orajel Nighttime Instant Relief for Teething Pain cherry flavored gel NEW and IMPROVED FORMULA LONGER LASTING EXTRA STRENGTH for Nighttime NET WT 0.18 OZ (5.1g) GEL ORAL PAIN RELIEVER FOR TEETHING BENZOCAINE 10% Carton image Carton image" ], "indications_and_usage": [ "Use for the temporary relief of sore gums due to teething in infants and children 4 months or age and older" ], "set_id": "0ab985a1-3a4c-4655-b2a8-6ca04cf48f19", "id": "f54dd296-e7e9-487c-aed4-bfd44fff43c9", "active_ingredient": [ "Active Ingredients Benzocaine 10%" ] }, { "effective_time": "20130801", "inactive_ingredient": [ "INACTIVE INGREDIENT colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, propylene glycol, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate." ], "purpose": [ "OTC - PURPOSE Pain reliever" ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks everyday while using this product take more or for a longer time than directed" ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN SILICON DIOXIDE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE 2208 (100 MPA.S) CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOLS STEARIC ACID TITANIUM DIOXIDE TALC CROSCARMELLOSE SODIUM PROPYLENE GLYCOL SODIUM BICARBONATE SODIUM LAURYL SULFATE TRIACETIN TRIETHYL CITRATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A SP;03" ], "ask_doctor": [ "OTC - ASK A DOCTOR BEFORE USE IF stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor" ], "pregnancy_or_breast_feeding": [ "OTC - IF PREGNANT OR BREAST FEEDING ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "OTC - STOP USE AND ASK A DOCTOR IF you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better allergic reaction occurs. Seek medical help right away. pain gets worse or lasts more than 10 days redness or swelling is present new symptoms occur ringing in the ears or loss of hearing occurs" ], "spl_unclassified_section": [ "OTHER INFORMATION store at 15°-30°C (59°-86°F) do not use if seal on the carton is missing or damaged" ], "do_not_use": [ "OTC - DO NOT USE If you are allergic to aspirin or any other pain reliever/fever reducer." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 4a9520e4-figure-01" ], "indications_and_usage": [ "INDICATIONS AND USAGE for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief." ], "set_id": "0acef886-9e67-463f-9901-cb43a6650ecd", "id": "4a9520e4-2015-4055-a4e2-ec077a8b5f30", "ask_doctor_or_pharmacist": [ "OTC - ASK A DOCTOR/PHARMACIST BEFORE USE IF YOU ARE taking a prescription drug for: Gout Diabetes arthritis" ], "active_ingredient": [ "OTC - ACTIVE INGREDIENT Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20121120", "inactive_ingredient": [ "Inactive ingredients Purified Water, Mineral Oil, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Propylene Glycol, Polysorbate 60, Sorbitan mono stearate, Methylparaben, Propylparaben." ], "purpose": [ "Purpose Antifungal" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use on children under 2 years of age except under the advice and supervision of a doctor. For external use only" ], "when_using": [ "When using this product avoid contact with eyes." ], "spl_product_data_elements": [ "Budpak Antifungal Clotrimazole Clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE WATER MINERAL OIL CETOSTEARYL ALCOHOL PETROLATUM GLYCERYL MONOSTEARATE PROPYLENE GLYCOL POLYSORBATE 60 SORBITAN MONOSTEARATE METHYLPARABEN PROPYLPARABEN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions wash affected area and dry thoroughly Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks if conditions persist longer, ask a doctor this product is not effective on the scalp or nails." ], "stop_use": [ "Stop using this product and ask a doctor irritation occurs there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch). do not use for diaper rash" ], "spl_unclassified_section": [ "Other information Store between 20ºC to 25º C (68ºF to 77ºF) Lot No. & Exp. Date: see crimp of tube.", "PRINCIPAL DISPLAY PANEL Budpak Antifungal Cream Clotrimazole 1% NET WT 0.5 OZ (14 g)" ], "package_label_principal_display_panel": [ "image of package label" ], "indications_and_usage": [ "Uses cures most athlete's foot, jock itch, and ringworm. relieves itching, burning, cracking, scaling and discomfort which accompany these conditions." ], "set_id": "0acfb654-fa70-4887-a67c-dfbe950f431a", "id": "4917ddf3-ebec-4149-b6d7-9fd4d59268b3", "active_ingredient": [ "Active Ingredient Clotrimazole 1%" ] }, { "effective_time": "20110111", "inactive_ingredient": [ "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.", "Inactive Ingredients:DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch", "Inactive Ingredient: Purified water" ], "purpose": [ "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Purpose: Pain reliever, fever reducer", "Purpose: Antihistimine", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or posion control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.", "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.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.", "Warnings Ask a doctor before use if you have: a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland if you are: taking any drugs for asthma taking sedatives or tranquilizers", "Warning: For external use only." ], "when_using": [ "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "When using this product Drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitaility may occur, especially in children", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "spl_product_data_elements": [ "ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 MEDIQUE DIPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 STARCH, CORN PINK WHITE CPC;835 MEDIQUE APAP Extra Strength ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN CROSPOVIDONE HYDROXYPROPYL CELLULOSE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WHITE AZ;235 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN white 44;157;ASPIRIN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: do not give to children under 12 years of age unless directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately." ], "storage_and_handling": [ "Other information: Store at room temperature.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967", "Store at room temperature. Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967" ], "do_not_use": [ "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor", "Do not use in the eyes or over large areas of the body." ], "package_label_principal_display_panel": [ "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "ASPIRIN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "Insect Sting Relief Pad", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "Aspirin 325 mg", "APAP_PDP", "apap_pdp", "DIPHEN_PDP", "DIPHEN_PANEL", "ONEPERSONKIT_FRONT", "ONEPERSONKIT_BACK" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever", "Uses Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itchy, watery eyes" ], "set_id": "0adedf0d-6c71-4ed9-963f-1fc41c1ae0f6", "id": "22f141f4-f307-4e18-a8ca-275e075f2547", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swellign is present" ], "active_ingredient": [ "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID * ) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 500 mg............................... Pain Reliever / fever reducer", "Active Ingredient (in each tablet) Purpose Diphenhydramine Hydrochloride 25mg............................... Antihistimine", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic" ] }, { "effective_time": "20111114", "inactive_ingredient": [ "Inactive Ingredients Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water" ], "purpose": [ "Purpose Skin Protectant" ], "keep_out_of_reach_of_children": [ "- Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately." ], "warnings": [ "Warnings - Do not use over deep or puncture wounds, infections, or lacerations. For external use only. - When using this product do not get into eyes. If contact occurs, rinse eyes throughout with water. - Stop use and ask a doctor if condition worsens or does not improve with 7 days." ], "spl_product_data_elements": [ "Rash Relief Clear Petrolatum Dimethicone Petrolatum Petrolatum Dimethicone Dimethicone Mineral Oil Cyclomethicone Lanolin Microcrystalline Wax Hexamethyldisiloxane Water Cholecalciferol Vitamin A Palmitate" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. - Shake bottle well before use. - Spray 4-6 inches from skin. No rub-in is required. - Apply liberally as often as necessary, with each diaper change, and especially at bedtime or anytime exposure to we diapers is prolonged." ], "package_label_principal_display_panel": [ "Enter section text here RRCL" ], "indications_and_usage": [ "Uses: Protects minor skin irritation due to diaper rash and helps seal out wetness." ], "set_id": "0b5753aa-b591-4d6e-8341-fcc9456299b6", "id": "f678f128-0e58-49db-a47d-21ab8f8c74a3", "active_ingredient": [ "Active Ingredients Dimethicone 20% Petrolatum 25%" ] }, { "effective_time": "20150112", "inactive_ingredient": [ "Inactive ingredients aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum" ], "purpose": [ "Purpose Topical analgesic" ], "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 get into eyes Stop use and ask a doctor if condition gets worse 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." ], "when_using": [ "When using this product do not get into eyes" ], "spl_product_data_elements": [ "Select Brand Anti-Itch Menthol and Pramoxine Hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM PROPYLPARABEN WATER METHYL SALICYLATE SODIUM ACRYLATE EDETATE DISODIUM METHYLPARABEN PPG-1 TRIDECETH-6 STEARYL ALCOHOL ALOE VERA LEAF MINERAL OIL .ALPHA.-TOCOPHEROL ACETATE EUCALYPTUS OIL DIAZOLIDINYL UREA TROLAMINE PROPYLENE GLYCOL PETROLATUM" ], "openfda": {}, "version": "9", "dosage_and_administration": [ "Directions adults and children 2 years and older: apply to affected area not more than 3 or 4 times daily children under 2 years: consult a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if condition gets worse symptoms last more than 7 days or clear up and occur again within a few days" ], "storage_and_handling": [ "Other Information store at controlled room temperature" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Select Brand Medicated Anti-Itch Cream Maximum Relief Topical Analgesic Net wt 1 oz (28.3 g) PDP rear" ], "indications_and_usage": [ "Uses for temporary relief of pain and itching due to: minor burns sunburn minor cuts scrapes insect bites minor skin irritations minor rashes due to poison ivy, poison oak, or poison sumac" ], "set_id": "0bacd190-b118-0df3-e054-00144ff8d46c", "id": "0bacd190-b119-0df3-e054-00144ff8d46c", "active_ingredient": [ "Active ingredients Menthol 1% Pramoxine hydrochloride 1%" ] }, { "effective_time": "20140221", "inactive_ingredient": [ "Inactive ingredients (Advanced Acne Treatment) benzyl alcohol, ceteareth-20, citric acid, disodium EDTA, purified water, sodium citrate, and xanthan gum pressurized with a hydrocarbon (propane/isobutane/butane propellant).", "Inactive Ingredients (Deep Cleanser) citric acid, disodium EDTA, purified water, sodium citrate, sodium lauryl sulfate, and xanthan gum pressurized with a hydrocarbon (propane/isobutane/butane propellant).", "Inactive Ingredients (Foaming Wash) cetearyl alcohol, cocamidopropyl betaine, glycerin, glycolic acid, hydrogenated castor oil, lactic acid, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, sodium hydroxide, sodium lauryl sulfate, sodium PCA, and titanium dioxide, zea mays (corn) starch.", "Inactive Ingredients (Spot Treatment) ceteareth-20, cetylalcohol, dimethyl isosorbide, fragrance, purified water, simethicone, stearyl alcohol" ], "purpose": [ "Purpose Acne medication" ], "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. (AAT, DC, FW)" ], "warnings": [ "Warnings For external use only Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide. Stop use and ask a doctor if • irritation becomes severe. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (AAT, DC, FW)" ], "questions": [ "Questions? call 1-888-784-3335 (1-888-STIEFEL). Side effects may be reported to the number." ], "spl_product_data_elements": [ "MaxClarity benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE BENZYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER CITRIC ACID MONOHYDRATE EDETATE DISODIUM WATER SODIUM CITRATE XANTHAN GUM MaxClarity benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CITRIC ACID MONOHYDRATE EDETATE DISODIUM WATER SODIUM CITRATE SODIUM LAURYL SULFATE XANTHAN GUM MaxClarity benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CETOSTEARYL ALCOHOL COCAMIDOPROPYL BETAINE GLYCERIN GLYCOLIC ACID HYDROGENATED CASTOR OIL LACTIC ACID MINERAL OIL POLYETHYLENE GLYCOL 600000 POTASSIUM PHOSPHATE, UNSPECIFIED FORM WATER SODIUM HYDROXIDE SODIUM LAURYL SULFATE SODIUM PYRROLIDONE CARBOXYLATE TITANIUM DIOXIDE STARCH, CORN MaxClarity benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE POLYOXYL 20 CETOSTEARYL ETHER CETYL ALCOHOL DIMETHYL ISOSORBIDE WATER DIMETHICONE SILICON DIOXIDE STEARYL ALCOHOL" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions (Advanced Acne Treatment) • Clean the area thoroughly before applying this product. • Shake can before use. • Invert can and then press firmly to dispense a small amount of foam (not more than a dollop the size of a golf ball). • Using fingers, cover the entire affected area with a thin layer 1 to 3 times daily. • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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. If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.", "Directions (Deep Cleanser) • Wet area to be cleaned. • Shake can before use. • Invert can and then press firmly to dispense a small amount of foam (not more than a dollop the size of a golf ball). • Apply and gently massage area for 1 to 2 minutes. • Rinse thoroughly and pat dry. • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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. • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.", "Directions (Foaming Wash) • Wet area to be cleansed. • Apply acne wash and gently massage area for 1 to 2 minutes. Rinse thoroughly and pat dry. • Because excessive drying of skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily, if needed or as directed by a doctor. • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.", "Directions (Spot Treatment) Clean the skin thoroughly before applying medication. 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 or three times daily if needed or as directed by a doctor. If going outside, apply sunscreen after using this product. Allow MaxClarity Spot Treatment to dry, then follow directions in the sunscreen labeling if irritation or sensitivity develops, stop use of both products and ask a doctor." ], "stop_use": [ "Stop use and ask a doctor if • irritation becomes severe." ], "storage_and_handling": [ "Other information (Advanced Acne Treatment, Deep Cleanser) Store at 68° to 77°F (20° to 25°C). Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).", "Other information (Foaming Wash) Store at controlled room temperature 59° - 86°F (15° - 30°C).", "Other information (Spot Treatment) Store at room temperature." ], "do_not_use": [ "Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0145-2842-02 MaxClarity™ foam acne medication Advanced Acne Treatment with VersaFoam® Technology Benzoyl Peroxide 2.5% Net Wt 2.64 Oz (75 g) MAXCLARITY is a trademark and VERSAFOAM is a registered trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories www.maxclarity.com To reorder call 877-LIKE-MAX Stiefel Laboratories, Inc. Research Triangle Park, NC 27709 DELIVERED IN VersaFoam-AF™ AQUEOUS FORMULATION CFC FREE 10000000093323 MaxClarity Advanced Acne Treatment label", "Principal Display Panel NDC 0145-2840-02 MaxClarity™ foam acne medication Deep Cleanser with VersaFoam® Technology Benzoyl Peroxide 2.5% Net Wt 2.64 Oz (75 g) MAXCLARITY is a trademark and VERSAFOAM is a registered trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories, Inc. www.maxclarity.com To reorder call 877-LIKE-MAX Stiefel Laboratories, Inc. Research Triangle Park, NC 27709 DELIVERED IN VersaFoam-AF™ AQUEOUS FORMULATION CFC FREE 10000000093321 MaxClarity Deep Cleanser label", "Principal Display Panel NDC 0145-2832-09 MaxClarityTM Foaming Wash Acne Medication Benzoyl Peroxide 2.5% Steiefel Net Wt. 5.5 Oz (156 g) Stiefel Laboratories, Inc. RTP, NC 27709 Rev. 1/12 MAXCLARITY is a trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories, Inc. www.maxclarity.com A102555 MaxClarity Foaming Wash Label", "Principal Display Panel NDC 0145-2847-10 MaxClarity™ Spot Treatment Acne Medication Benzoyl Peroxide 8% Net Wt. .35 Oz (10g) Stiefel Laboratories, Inc. RTP, NC 27709 2012 Stiefel Laboratories, Inc. Made in Canada Rev2/12 A102591 MaxClarity Spot Treatment Label" ], "indications_and_usage": [ "Use For the treatment of acne" ], "set_id": "0bdf0a5d-51ea-4136-a16d-1c115bc7877d", "id": "edd1b73a-f40e-4bcf-afbd-45f2ab25eb38", "active_ingredient": [ "Active ingredient (Advanced Acne Treatment, Deep Cleanser, Foaming Wash) Benzoyl peroxide 2.5%", "Active Ingredient (Spot Treatment) Benzoyl peroxide 8%" ] }, { "effective_time": "20121030", "inactive_ingredient": [ "INACTIVE INGREDIENTS MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL." ], "purpose": [ "PURPOSE SKIN PROTECTANT" ], "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 DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. STOP USING THIS PRODUCT AND ASK A DOCTOR IF CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES, OR ON SERIOUS BURNS. 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 DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. STOP USING THIS PRODUCT AND ASK A DOCTOR IF CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES, OR ON SERIOUS BURNS. 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": [ "RITE AID RENEWAL PETROLATUM PETROLATUM PETROLATUM MINERAL OIL CERESIN LANOLIN ALCOHOLS PANTHENOL GLYCERIN LEVOMENOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY AS NEEDED." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK A DOCTOR IF CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES, OR ON SERIOUS BURNS. 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 TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND LIPS. HELPS PROTECT FROM THE DRYING EFFECTS OF COLD WIND AND WEATHER." ], "set_id": "0c67b5de-8c7b-4e6b-ba4e-660f10b51d70", "id": "db573480-8363-4dfb-a968-d58c416f794a", "active_ingredient": [ "ACTIVE INGREDIENT PETROLATUM 41% PURPOSE SKIN PROTECTANT" ] }, { "effective_time": "20130311", "inactive_ingredient": [ "Inactive Ingredients Synthetic Beeswax, Mineral Oil, Microcrystalline Wax, Lanolin, Camphor, Copernicia Cerifera (Carnauba) Wax, Menthol, Theobroma Cacao (Cocoa) Seed Butter, Salicylic Acid, Phenol, Flavor" ], "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 immediately. Do not induce vomiting before contacting a Poison Control Center." ], "warnings": [ "Warnings For external use only: When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and consult a doctor if: condition worsens or lasts more than 7 days. Do not induce vomiting before contacting a Poison Control Center. For adults and children over 2 years of age." ], "spl_product_data_elements": [ "Care One Medicated Lip Balm in a Pot Petrolatum PETROLATUM PETROLATUM WHITE WAX MINERAL OIL MICROCRYSTALLINE WAX LANOLIN 3-BROMOCAMPHOR, (+/-)- CARNAUBA WAX COCOA BUTTER MENTHOL 2-BUTANOYLOXYBENZOIC ACID PHENOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply liberally and evenly. Reapply as needed." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Care One Medicated Lip Balm Pot Card" ], "indications_and_usage": [ "Uses Helps prevent and temporarily protect dry and chapped lips." ], "set_id": "0c9d4c39-a4ba-41d6-80f5-93bf38961de4", "id": "0c9d4c39-a4ba-41d6-80f5-93bf38961de4", "active_ingredient": [ "Active ingredient Petrolatum" ] }, { "effective_time": "20130221", "inactive_ingredient": [ "Inactive ingredients aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol" ], "purpose": [ "Purpose Anti-itch cream" ], "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 in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you have a vaginal discharge rectal bleeding diaper rash When using this product consult a doctor before exceeding recommended dosage Stop use and ask a doctor if condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted 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 consult a doctor before exceeding recommended dosage" ], "questions": [ "Questions? Call 1-866-923-4914" ], "spl_product_data_elements": [ "Hydrocortisone with Aloe Hydrocortisone Hydrocortisone Hydrocortisone cetostearyl alcohol sodium lauryl sulfate sodium cetostearyl sulfate citric acid monohydrate glycerin glyceryl monostearate methylparaben mineral oil paraffin propylparaben water stearyl alcohol" ], "ask_doctor": [ "Ask a doctor before use if you have a vaginal discharge rectal bleeding diaper rash" ], "openfda": {}, "version": "1", "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: do not use. consult a doctor For external anal itching: Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor" ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY MEIJER DISTRIBUTION, INC. 2929 WALKER AVE NW GRAND RAPIDS, MI 49544" ], "stop_use": [ "Stop use and ask a doctor if condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor." ], "storage_and_handling": [ "Other information To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube store at room temperature see carton or tube crimp for lot number and expiration date" ], "do_not_use": [ "Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 60 g Tube Carton meijer ™ Compare to Cortizone•10 ® active ingredient* Maximum Strength With Aloe Anti-Itch Relief 1% Hydrocortisone Cream Antipruritic NET WT 2 0Z (60 g) Principal Display Panel - 60 g Tube Carton" ], "indications_and_usage": [ "Uses temporary relief of itching associated with minor skin irritations and rashes due to eczema insect bites poison ivy, poison oak, or poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis external genital and anal itching other uses of this product should be only under the advice and supervision of a doctor" ], "set_id": "0ccbc9a6-a705-4604-b9d4-078f0dc36a03", "id": "4cfb507c-dc92-4282-9931-fd9c57510d1a", "active_ingredient": [ "Active ingredient Hydrocortisone 1%" ] }, { "effective_time": "20100517", "inactive_ingredient": [ "Inactive ingredients Aqua (Water), Butylene glycol, C12-15 alkyl benzoate, Dimethicone, Glycerin, Silica, Cetearyl alcohol, Glyceryl stearate, Petrolatum, Caprylic/capric triglyceride, Paraffinum liquidum (Mineral oil), Hydrogenated coco-glycerides, Cetearyl ethylhexanoate, PEG-100 stearate, Simmondsida chinensis (Jojoba) seed oil, Talc, Alcohol denat., Phenoxyethanol, Sodium polyacrylate, PEG-20 stearate, PVP/hexadecene copolymer, Methylparaben, Sodium stearoyl lactylate, Xanthan gum, Isopropyl myristate, Parfum (Fragrance), Propylparaben, Tetrasodium EDTA, Zingiber officinalis (Ginger) root extract, Butylphenyl methylpropional, Hexyl cinnamal, Linalool, Hydroxyisohexyl 3-cyclohexenecarboxaldehyde, BHT, Citronellol, Diethyl phthalate, [+/- (may contain CI 77891 (Titanium dioxide), CI 77492 (Iron oxides) CI 77491 (Iron oxides) CI 77499 (Iron oxides)]." ], "purpose": [ "Uses Provides moderate protection against the adverse effects of the sun. Higher SPF gives more protection." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help." ], "questions": [ "USA: Questions? 1-866-75-BOOTS www.boots.com", "USA: Questions? 1 -866-75-BOOTS" ], "spl_product_data_elements": [ "Botanics Quench Your Face Foundation Sunscreen SPF 12 Star Anise 40 Octinoxate and Avobenzone OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE WATER BUTYLENE GLYCOL C12-15 ALKYL BENZOATE DIMETHICONE GLYCERIN SILICON DIOXIDE CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE PETROLATUM MEDIUM-CHAIN TRIGLYCERIDES MINERAL OIL POLYOXYL 100 STEARATE JOJOBA OIL TALC PHENOXYETHANOL METHYLPARABEN XANTHAN GUM ISOPROPYL MYRISTATE PROPYLPARABEN EDETATE SODIUM GINGER BUTYLATED HYDROXYTOLUENE TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "With GINGER and JOJOBA to help moisturise. BENEFITS Botanics Quench Your Face Foundation hydrates and protects with SPF12. Light reflecting properties enhance the appearance of your complexion. Provides light to medium coverage. Suitable for all skin types.", "Bottle back label 40 STAR ANISE With GINGER and Jojoba to help moisturise. BENEFITS Botanics Quench Your Face Foundation hydrates and protects with SPF12. Light reflecting properties enhance the appearance of your complexion. Provides light to medium coverage. See carton for complete information. ACTIVE INGREDIENTS Avobenzone 1.5% Octinoxate 6% PURPOSE Sunscreens USE Provides moderate protection against adverse effects of the sun. 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. Mfd in France for BBI Ltd NG2 3AA. UK. Dist in the USA by Boots Retail USA INC., Stamford, CT 06901. USA: Questions? 1-866-75-BOOTS www.boots.com" ], "warnings_and_cautions": [ "Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove." ], "ask_doctor": [ "Stop use and ask a doctor if rash or irritation develops and lasts." ], "openfda": {}, "version": "1", "storage_and_handling": [ "Other information Do not store above 30 o C or 86 o F" ], "information_for_patients": [ "Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford, CT 06901" ], "package_label_principal_display_panel": [ "BOOTS The Power of Plants BOTANICS QUENCH YOUR FACE FOUNDATION SUNSCREEN SPF 12 30ml e 1 US Fl. Oz QYF Fdn carton.jpg QYF Fdn carton", "Bottle front label Boots The Power of Plants BOTANICS QUENCH YOUR FACE FOUNDATION SUNSCREEN SPF 12 30ml e 1 US Fl. Oz QYF Fdn front label.jpg QYF Fdn front label" ], "indications_and_usage": [ "Directions Use as a normal foundation. Apply evenly at least 15 minutes before sun exposure. Reapply as required. Not intended for children under the age of 12. Not intended for protection whilst sunbathing." ], "set_id": "0d40e9ab-ab01-4b26-bc23-e161a652f7d0", "id": "4b05839d-27ff-404c-8158-b705c7ff4b10", "active_ingredient": [ "Active Purpose Ingredients Octinoxate 6% Sunscreens Avobenzone 1.5%" ] }, { "effective_time": "20100515", "inactive_ingredient": [ "Inactive Ingredients: Water, Eucalyptus Citriodora Oil, Mineral Oil, Dipropylene Glycol, Cetearyl Alcohol, Betaine, Cetearyl Ethylhexanoate, Portulaca Oleracea Extract, Glyceryl Stearate, PEG-40 Stearate, Aloe Barbadensis Leaf Extract, PEG-100 Stearate, Sorbitan Stearate, Allantoin, Silica, Bees wax, Dimethicone, Fragrance, Phenoxyethanol, Methylparaben, Carbomer, Triethanolamine, Propylparaben, Xanthan Gum, Disodium EDTA" ], "keep_out_of_reach_of_children": [ "Warning for Child 1) Do not use for under 3 year-old baby 2) Be careful to use for children and do not make child to use by himself 3) Keep out of infant's and children's reach" ], "when_using": [ "Directions for Use - Smear appropriate amount and smooth on the exposing skin" ], "spl_product_data_elements": [ "DooBony Mosrepel GLYCERIN GLYCERIN GLYCERIN" ], "description": [ "Characteristics: - No DEET inside - Natural Plan Extracts keep mosquitos away with unique and mild fragrance - Useful design to use without applying to palm - Safe and certified materials inside only" ], "openfda": {}, "version": "1", "do_not_use": [ "Cautionn 1) In case of below symptoms on skin, stop using - Red spot, swelling, itching, irritation - Occurrence of above symptom after exposure to direct sunlight 2) Avoid contact with the eyes. If contacts with eyes, follow below direction - Wash the eyes sufficiently - If wearing contact lenses, wash for 5 minutes and take the lenses out - If necessary, consult a doctor 3) If swallowed, see a doctor at once. If there is no direction from doctor, take a glassful water slowly instead of vomiting 4) Avoid using on wounds 5) Wash the range of application clearly with water and soap after using 6) Apply only for external use 7) Follow below direction for storing or treating - Always close the lid after use - Avoid storing in direct sunlight or excessive heat/cold" ], "package_label_principal_display_panel": [ "Box Label" ], "set_id": "0da77e1f-0bda-483f-970b-989d55e1bb33", "id": "f909739e-721b-4554-a94c-b077ddf59571", "active_ingredient": [ "Active Ingredient: Glycerin 5%" ] }, { "effective_time": "20110919", "purpose": [ "Active ingredients: Purpose: Hydroquinone USP 2% Skin Lightener Oxybenzone USP 2.5% Sunscreen Padimate O USP 3.3% 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." ], "when_using": [ "When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure" ], "questions": [ "Questions? 1-800-900-6389 (24 hours a day, 7 days a week)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a healthcare professional before use." ], "storage_and_handling": [ "Other information • Store at room temperature • Tamper-evident carton • Serious side effects may be reported to the phone number provided in the Questions? section below." ], "indications_and_usage": [ "Use Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptions. Contains a sunscreen to help prevent darkening from reoccurring." ], "set_id": "0de38654-f598-4cca-9e1e-47af1f21d21c", "id": "7d2ff072-8745-4a24-9ee4-6caf23fa9ad2", "active_ingredient": [ "Active ingredients: Purpose: Hydroquinone USP 2% Skin Lightener Oxybenzone USP 2.5% Sunscreen Padimate O USP 3.3% Sunscreen" ], "inactive_ingredient": [ "Inactive ingredients purified water USP, glyceryl monostearate, isopropyl palmitate NF, ozokerite wax, mineral oil light NF, stearyl alcohol NF, PEG 1500 monostearate, poloxamer 188, propylene glycol USP, steareth-20, laureth-23, allantoin ascorbate, sodium bisulfite NF, steareth-10, dimethicone, sodium lauryl sulfate NF, methylparaben NF, fragrance, propylparaben NF, edetate disodium, butylated hydroxyanisole" ], "warnings": [ "Warnings For external use only. Do not use • On inflamed or broken skin • For prevention of sunburn • As sunscreen • On children under 12 years of age unless directed by a physician Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away." ], "spl_product_data_elements": [ "Esoterica Daytime with Sunscreen hydroquinone, oxybenzone, and padimate o hydroquinone hydroquinone oxybenzone oxybenzone padimate o padimate o water glyceryl monostearate isopropyl palmitate ceresin mineral oil stearyl alcohol polyethylene glycol 1500 poloxamer 188 propylene glycol steareth-20 laureth-23 allantoin sodium bisulfite steareth-10 dimethicone sodium lauryl sulfate methylparaben propylparaben edetate disodium butylated hydroxyanisole" ], "ask_doctor": [ "Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor • For sensitive skin, test overnight on small area (inside elbow) • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: MEDICIS The Dermatology Company ® Scottsdale, AZ 85256" ], "do_not_use": [ "Do not use • On inflamed or broken skin • For prevention of sunburn • As sunscreen • On children under 12 years of age unless directed by a physician" ], "active_ingredient_table": [ "
Active ingredients: Purpose:
Hydroquinone USP 2% Skin Lightener
Oxybenzone USP 2.5% Sunscreen
Padimate O USP 3.3% Sunscreen
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 70g Carton Skin Lightener with Sunscreen NDC # 99207-292-02 E ESOTÉRICA ® ESOTÉRICA ® FADE CREAM DAYTIME With Sunscreen Net Wt. 2.5 oz (70g) Principal Display Panel - 70g Carton" ], "purpose_table": [ "
Active ingredients: Purpose:
Hydroquinone USP 2% Skin Lightener
Oxybenzone USP 2.5% Sunscreen
Padimate O USP 3.3% Sunscreen
" ] }, { "effective_time": "20100201", "purpose": [ "PURPOSE Protectant Vasoconstrictor Local anesthetic 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." ], "when_using": [ "When using this product do not exceed the recommended daily dosage unless directed by a doctor" ], "questions": [ "Questions? Call 1-800-910-6874" ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding ask a health professional before use." ], "storage_and_handling": [ "OTHER INFORMATION Store at room temperature: 20° - 25° C (68° - 77° F)" ], "indications_and_usage": [ "USES Temporarily relieves pain, soreness and burning Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful" ], "set_id": "0dea93da-f123-4b01-b821-85ea3cd61423", "id": "dc36f647-2d3c-442b-b16d-7c0ac65414c6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression." ], "active_ingredient": [ "ACTIVE INGREDIENTS Glycerin, USP 14.4% Phenylephrine HCI, 0.25% Pramoxine HCI, 1% White petrolatum, 15%" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS aloe barbadensis leaf extract, BHA, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, tocopherol. vitamin E, xanthan gum" ], "warnings": [ "WARNINGS Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if bleeding occurs the introduction of the applicator causes additional pain condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.", "" ], "spl_product_data_elements": [ "glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum GLYCERIN GLYCERIN ALOE VERA LEAF BUTYLATED HYDROXYANISOLE CARBOXYMETHYLCELLULOSE SODIUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PRAMOXINE HYDROCHLORIDE PRAMOXINE CETYL ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERYL MONOSTEARATE LAURETH-23 METHYLPARABEN LIGHT MINERAL OIL PANTHENOL PROPYL GALLATE PETROLATUM PETROLATUM PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM BENZOATE STEARYL ALCOHOL ALPHA-TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE, DL- XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes difficulty in urination due to enlargement of the prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream. When first opening the tube, puncture foil seal with top end of cap Apply externally or in the lower portion of the anal canal only Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate applicator well, then gently insert applicator into the rectum. Thoroughly clean dispensing cap after each use and replace cover Children under 12 years: ask a doctor." ], "stop_use": [ "Stop use and ask a doctor if bleeding occurs the introduction of the applicator causes additional pain condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase" ], "spl_unclassified_section": [ "" ], "do_not_use": [ "" ], "package_label_principal_display_panel": [ "PACKAGE INFORMATION - TUBE up and up NDC 11673-572-24 Hemorrhoidal Cream maximum strength Compare to Preparation H® Hemorrhoidal Cream* Helps shrink swelling of irritated hemorrhoidal tissues NET WT 1.8 OZ (51 g) This tube is sealed and packaged in a carton. Do not buy if carton is missing . Do not use if the seal under the cap has been punctured or if the tube is damaged. *This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Preparation H®. Dist. by Target Corp. Minneapolis, MN 55403 Made in U.S.A. ® and © 2009 Target Brands, Inc. All Rights Reserved Shop Target.com tube", "PACKAGE INFORMATION - BOX up and up NDC 11673-572-24 Hemorrhoidal Cream maximum strength Compare to Preparation H® Hemorrhoidal Cream* Helps shrink swelling of irritated hemorrhoidal tissues NET WT 1.8 OZ (51 g) DO NOT USE IF SEAL UNDER CAP OF TUBE IS BROKEN OR MISSING WHEN PURCHASED. *This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Preparation H®. Distributed by Target Corporation Minneapolis, MN 55403 Made in U.S.A. ® and © 2009 Target Brands, Inc. All Rights Reserved Shop Target.com box" ] }, { "effective_time": "20141207", "inactive_ingredient": [ "Inactive Ingredients WATER/EAU (AQUA), CYCLOMETHUCONE, DECYL OLEATE, GLYCERIN , C12-15 ALKLYL BENZOATE, SODIUM CHLORIDE, PEG/PPG-18/18 DIMETHICONE GLYCERYL STEARATE, ASCORBYL PALMITATE BHT, BUTYLPARABEN, CAPRYLIC/CAPRIC TRIGLYCERIDE, CITRUS AURANTIUM DULCIS (ORANGE) OIL (CITRUS AURANTIUM DULCIS OIL), DISODIUM EDTA, DISTEARDIMONIUM HECTORITE, ETHYLPARABEN, FRAGRANCE/PARFUM, HYDROGENATED-PALM GLYCERIDES CITRATE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), ISOBUTYLPARABEN, LECITHIN, METHYLPARABEN, MINERAL OIL/HUILE MINERALE (PARAFINUM LIQUIDUM), OCTYLDODECANOL oCYME-5-OL OZOKERITE, PEG-30 DIPOLYHYDROXYSTEARATE, PETROLATUM, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, PPG-3 MYRISTYL ETHER, PROPYLPARABEN, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL (ROSMARINUS OFFICINALIS LEAF OIL) SILICA DIMETHYL SILYLATE, SODIUM MYRISTOYL GLUTAMATE, TOCOPHEROL, TOCOPHERYL GLUCOSIDE, TRIMETHOXYCAPRYLYLSILANA, XANTHAN GUM." ], "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 When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs." ], "questions": [ "Questions ? Questions ? : 1-866-41-AVENE (USA) / 1-877-441-2011 (CAN)" ], "spl_product_data_elements": [ "EAU THERMALE Avene High Protection Mineral BROAD SPECTRUM SPF 50 TITANIUM DIOXIDE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE DIMETHICONE HYDROGENATED POLYBUTENE (1300 MW) WATER CYCLOMETHICONE DECYL OLEATE GLYCERIN ALKYL (C12-15) BENZOATE SODIUM CHLORIDE PEG/PPG-18/18 DIMETHICONE GLYCERYL MONOSTEARATE ASCORBYL PALMITATE BUTYLATED HYDROXYTOLUENE BUTYLPARABEN MEDIUM-CHAIN TRIGLYCERIDES ORANGE OIL EDETATE DISODIUM DISTEARDIMONIUM HECTORITE ETHYLPARABEN HYDROGENATED PALM GLYCERIDES FERRIC OXIDE YELLOW FERRIC OXIDE RED ISOBUTYLPARABEN EGG PHOSPHOLIPIDS METHYLPARABEN MINERAL OIL OCTYLDODECANOL O-CYMEN-5-OL CERESIN PEG-30 DIPOLYHYDROXYSTEARATE PETROLATUM PHENOXYETHANOL POLYHYDROXYSTEARIC ACID (2300 MW) PPG-3 MYRISTYL ETHER PROPYLPARABEN ROSEMARY OIL SILICON DIOXIDE SODIUM MYRISTOYL GLUTAMATE TOCOPHEROL TRIMETHOXYCAPRYLYLSILANE XANTHAN GUM" ], "openfda": {}, "version": "2", "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. 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 of 15 or higher and other skin 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: Ask a doctor" ], "storage_and_handling": [ "Other Information Protect this product from excessive heat and direct sun." ], "package_label_principal_display_panel": [ "EAU THERMALE Avene High Protection Mineral Cream BROAD SPECTRUM SPF 50 50ml/1.69 FL.OZ (67015-0003-0) InnerLabel OuterLabel" ], "indications_and_usage": [ "Uses Helps prevent sunburn If used as directed with other sun protection measures ( see Directions ) decreases the risk if skin cancer and early skin aging caused by the sun." ], "set_id": "0eb6b966-a4dc-4fc4-8604-5bbf6675444a", "id": "5093ebc6-cec5-42cd-a23e-a546986b0c80", "active_ingredient": [ "Active Ingredients TITANIUM DIOXIDE 10.78 % ZINC OXIDE 2.40 %" ] }, { "effective_time": "20130514", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium*, hypromellose, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, propylene glycol*, starch, titanium dioxide* * may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "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 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcohol drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-835-2263" ], "spl_product_data_elements": [ "Physicians Care Aspirin Aspirin ASPIRIN ASPIRIN CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSES MINERAL OIL STARCH, CORN TITANIUM DIOXIDE white ROUND TCL;011" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at room temperature 59º-86ºF (15º-30ºC) avoid excessive heat and humidity tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis" ], "package_label_principal_display_panel": [ "Principal Display Panel", "116R Physicians Care-Aspirin 325 mg Label Physicians Care® ASPIRIN Fever Reducer and Pain Reliever (NSAID) Pull To Open COATED TABLETS Compare Active ingredients to: Bayer® Registered Trademark of Bayer AG Tamper-Evident Packets of 2 Tablets See new warnings information Physicians Care® Registered Trademark of ACME UNITED Corporation 50 PACKETS (2 Tablets 325 Mg Each) 116R Physicians Care-Aspirin 325 mg Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache minor arthritis common cold menstrual cramps muscular aches backache toothache Temporarily reduces fever." ], "set_id": "0f187bdc-9488-40f2-9528-f14ee3b971c6", "id": "84a4df18-b370-4b82-b137-0300f14856bb", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin (NSAID*) 325 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20101119", "inactive_ingredient": [ "Inactive Ingredients Water, Mineral Oil, White Petrolatum, Ceresin, Sorbitan Sesquioleate, Sorbitol, Lanolin Alcohol, Aluminum Hydroxide, Magnesium Hydroxide, BHT Ethylhexylglycerin, Phenoxyethanol" ], "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 This Product Keep out of eyes. Rinse eyes thoroughly with water to remove. 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 Do Not Use On deep or puncture wounds animal bites serious burns 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 eyes thoroughly with water to remove." ], "questions": [ "Questions? 9a-5p weekdays M-F CST 1-877-725-7274" ], "spl_product_data_elements": [ "NeutrapHor Skin Protectant Dimethicone Dimethicone Dimethicone Water Mineral Oil Petrolatum Sorbitan Sesquioleate Sorbitol Lanolin Alcohols Aluminum Hydroxide Magnesium Hydroxide Butylated Hydroxytoluene Ethylhexylglycerin Phenoxyethanol" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Apply cream liberally as often as needed" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by GinJen Hammond, LA 70401" ], "stop_use": [ "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" ], "do_not_use": [ "Do Not Use On deep or puncture wounds animal bites serious burns" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 57 g jar label PATENTED Smooth, Soothing, Cooling Cream for Skin Affected by Incontinence and Inactivity NEW DEVELOPED BY A PHYSICIAN NeutrapHor ® SKIN PROTECTANT CREAM Long Term Relief pH-Mediated CLINIC FRAGRANCE FREE Distributed by GinJen Hammond, LA 70401 1-8 77-725-72 74 Patent 6805875 Patents Pending 2.0 oz (57 g) www.neutraphor.com Principal Display Panel - 57 g jar label" ], "indications_and_usage": [ "Uses temporarily protects and helps relieve chapped or cracked skin temporarily protects minor cuts scrapes burns" ], "set_id": "0f3a5ca3-c4bd-4496-bb62-816d1ed9f01f", "id": "84104452-0a4d-47f2-a65d-c9c3fd85f9a8", "active_ingredient": [ "Active Ingredient Dimethicone 1%" ] }, { "effective_time": "20150929", "inactive_ingredient": [ "Inactive Ingredients Calamine, DMDM Hydantoin, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Phenol, Propylparaben, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearyl Alcohol, Sorbitan Sesquioleate, Sodium bicarbonate and Thymol" ], "purpose": [ "Uses A moisture barrier that prevents and helps heal skin irritation from Urine, diarrhea, perspiration, fistula drainge, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN In the event of accidental ingestion contact a Poison Control Center right away" ], "warnings": [ "Warnings FOR EXTERNAL USE ONLY Not for deep or puncture wounds Avoid contact with eyes If condition worsens or does not improve within 7 days, consult a doctor" ], "spl_product_data_elements": [ "Caladrox Menthol, Zinc Oxide MENTHOL MENTHOL ZINC OXIDE ZINC CATION GLYCERIN LANOLIN PHENOL SODIUM BICARBONATE THYMOL SODIUM LAURETH SULFATE METHYLPARABEN PROPYLPARABEN DMDM HYDANTOIN STEARYL ALCOHOL PROPYLENE GLYCOL SORBITAN SESQUIOLEATE MINERAL OIL PETROLATUM WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply a thin layer of Caladrox Ointment to reddened or irritated skin 2-4 times daily." ], "storage_and_handling": [ "Storage Store at room temperature 15°-30°C (59°-86°F)" ], "package_label_principal_display_panel": [ "Label of Tube" ], "indications_and_usage": [ "Directions Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Caladrox Ointment to reddened or irritated skin 2-4 times daily or after each incontinent episode or diaper change to promote comfort and long lasting protection" ], "set_id": "0fb20544-54bd-4f7a-8372-8a4dd1d79d21", "id": "5977ea44-7dbe-476e-9691-421d2b5d14f6", "active_ingredient": [ "Drug Facts Active Ingredient: Purpose: Menthol 0.44% External analgesic First aid antiseptic / antipruritic Zinc Oxide 20.0% Skin protectant / moisture barrier" ] }, { "effective_time": "20110408", "inactive_ingredient": [ "Inactive Ingredients Hexamethyldisiloxane, Softisan 649, Mineral Oil, Aloe Extract." ], "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. Do not use on deep or puncture wounds animal bites serious burns. When using this product avoid spraying in eyes do not intentionally inhale. Stop use and see a doctor if condition lasts more than 7 days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Flammable Contents under pressure Keep away from heat, sparks, and open flame. Do not puncture or incinerate container. Exposure to temperatures above 120 o F may cause bursting.", "Flammable Contents under pressure Keep away from heat, sparks, and open flame. Do not puncture or incinerate container. Exposure to temperatures above 120 o F may cause bursting." ], "when_using": [ "When using this product avoid spraying in eyes do not intentionally inhale." ], "spl_product_data_elements": [ "ALOE VESTA PROTECTIVE BARRIER PETROLATUM PETROLATUM PETROLATUM HEXAMETHYLDISILOXANE MINERAL OIL ALOE VERA LEAF Off-white" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Do not overspray. Shake before use. Hold can 4-6 inches from skin and spray. For skin protection Apply a thin continuous coating as needed. For diaper rash Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply as needed, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged." ], "stop_use": [ "Stop use and see a doctor if condition lasts more than 7 days." ], "spl_unclassified_section": [ "Other Information Store at 15 o C - 30 o C (59 o F - 86 o F)." ], "do_not_use": [ "Do not use on deep or puncture wounds animal bites serious burns." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 43553-4134-1 ConvaTec ALOE VESTA TM Protective Barrier Spray 3 PROTECT SKIN PROTECTANT Shake before use Soothes irritated skin For weepy, denuded skin Apply from any angle Easy to remove NET WT. 2.1 oz.(60g) CSX1876A Case Order No. 413401 Aloe Vesta Protective Barrier Spray Label" ], "indications_and_usage": [ "Uses Temporarily protects minor cuts scrapes burns. Temporarily protects and helps relieve chapped or cracked skin. Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness." ], "set_id": "10341c96-b4ba-4892-ab68-2ac66f29da96", "id": "c83c8a0d-a979-4024-9f02-01392449ecbc", "active_ingredient": [ "Active Ingredient Petrolatum 36%" ] }, { "effective_time": "20110322", "inactive_ingredient": [ "Inactive ingredients cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin" ], "purpose": [ "Purpose Oral Pain Reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy Alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics" ], "questions": [ "Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com" ], "spl_product_data_elements": [ "Baby Orajel Instant Relief for Teething Pain Longer Lasting Benzocaine BENZOCAINE BENZOCAINE CARBOXYMETHYLCELLULOSE SODIUM GELATIN MINERAL OIL PECTIN PETROLATUM POLYETHYLENE GLYCOL FD&C RED NO. 40 SACCHARIN SODIUM cherry flavored" ], "ask_doctor": [ "When using this produ c t fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your doctor. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, irritation, pain or redness does not go away, swelling, rash or fever develops" ], "other_safety_information": [ "Other information do not use if tube tip is cut prior to opening" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions wash hands cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Baby Orajel apply to the affected area up to 4 times daily or as directed by a dentist or doctor for infants under 4 months of age, ask a dentist or doctor" ], "do_not_use": [ "Do not use more than directed for more than 7 days unless directed by a dentist or doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel No 1 TEETHING BRAND used by Pediatricians Baby Orajel Instant Relief for Teething Pain cherry flavored gel NEW AND IMPROVED FORMULA LONGER LASTING NET WT 0.33 OZ (9.4g) Gel ORAL PAIN RELIEVER FOR TEETHING ENZOCAINE 7.5% Carton image Carton image" ], "indications_and_usage": [ "USE For the temporary relief of sore gums due to teething in infants and children 4 months of age and older" ], "set_id": "1051cca1-ff94-4d1a-a5d3-ab943a1321ef", "id": "e59620e3-9ffc-4611-b4d2-1ca88375a427", "active_ingredient": [ "Active ingredients Benzocaine 7.5%" ] }, { "effective_time": "20130702", "inactive_ingredient": [ "Inactive ingredients lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin image of carton" ], "purpose": [ "Purpose Guaifenesin.......................Expectorant Phenylephrine HCl..............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 immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage" ], "spl_product_data_elements": [ "Skopko Chest Congestion Relief PE PE Guaifenesin/phenylephrine Guaifenesin Guaifenesin PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM LACTOSE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE MINERAL OIL POVIDONE MAGNESIUM SILICATE MAGNESIUM STEARATE RCCGPE;C27" ], "ask_doctor": [ "Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ excessive phlegm;mucus ■ difficulty in urination due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by 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 occurs ■ symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) ■ cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition ." ], "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 are uncertain whether your prescription drug contains an MAOI, ask a health professional." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive" ], "set_id": "10874e99-e7fa-4994-9af8-7e203262b1cc", "id": "096b79d6-3275-42b2-99ba-fed836ade8dc", "active_ingredient": [ "Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg" ] }, { "effective_time": "20150325", "inactive_ingredient": [ "Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately. Directions - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times a day Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic" ], "purpose": [ "Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic" ], "warnings": [ "Warnings Warnings For external use only. Avoid contact with eyes Do Not Use Do not use - by mouth - in nostrils - on wounds or damaged skin - with tight bandages Ask a doctor before use if you have Ask a doctor before use if you have - asthma - excessive phlegm (mucus) - emphysema - persistent or chronic cough - cough associated with smoking If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately. Directions - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times a day Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic" ], "spl_product_data_elements": [ "Premier Value Medicated Chest Rub Camphor Eucalyptus Menthol CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) EUCALYPTUS OIL EUCALYPTUS OIL MENTHOL MENTHOL PETROLATUM NUTMEG OIL TURPENTINE CEDAR LEAF OIL MINERAL OIL THYMOL" ], "ask_doctor": [ "Ask a doctor before use if you have Ask a doctor before use if you have - asthma - excessive phlegm (mucus) - emphysema - persistent or chronic cough - cough associated with smoking If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately. Directions - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times a day Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic", "Stop use and ask a doctor if Stop use and ask a doctor if -muscle aches/pain persist more than 7 days or come back -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." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times a day Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately. Directions - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times a day Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic" ], "storage_and_handling": [ "Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic" ], "do_not_use": [ "Do Not Use Do not use - by mouth - in nostrils - on wounds or damaged skin - with tight bandages Ask a doctor before use if you have Ask a doctor before use if you have - asthma - excessive phlegm (mucus) - emphysema - persistent or chronic cough - cough associated with smoking If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately. Directions - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times a day Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic", "When using this product do not When using this product do not -heat -microwave -use near open flame -add to hot water or any container where heating may cause splattering and result in burns" ], "package_label_principal_display_panel": [ "Product Label Product Label" ], "indications_and_usage": [ "Uses Uses - On chest and throat, temporarily relieves cough due to common cold - On the muscles and joints, temporarily relieves minor aches and pains Warnings Warnings For external use only. Avoid contact with eyes Do Not Use Do not use - by mouth - in nostrils - on wounds or damaged skin - with tight bandages Ask a doctor before use if you have Ask a doctor before use if you have - asthma - excessive phlegm (mucus) - emphysema - persistent or chronic cough - cough associated with smoking If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately. Directions - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times a day Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic" ], "set_id": "10aa8e6e-19ec-4674-a275-3dba6ca8acb2", "id": "21db12e3-79e9-4a61-bbe1-8ba795231bce", "active_ingredient": [ "Active Ingredients Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic Uses Uses - On chest and throat, temporarily relieves cough due to common cold - On the muscles and joints, temporarily relieves minor aches and pains Warnings Warnings For external use only. Avoid contact with eyes Do Not Use Do not use - by mouth - in nostrils - on wounds or damaged skin - with tight bandages Ask a doctor before use if you have Ask a doctor before use if you have - asthma - excessive phlegm (mucus) - emphysema - persistent or chronic cough - cough associated with smoking If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately. Directions - children under 2 years of age, ask a doctor before using the product - adults and children 2 years and older: rub a thick layer on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times a day Other information Other information -store at room temperature Inactive Ingredients cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil, mineral oil Purpose Ingredients Purpose Camphor 4.8%.............cough suppressant/topical analgesic Eucalyptus oil 1.2%.......cough suppressant Menthol 2.6%...............cough supressant/topical analgesic" ] }, { "effective_time": "20141023", "inactive_ingredient": [ "Inactive ingredients Dragon's blood (resin), eucalyptus oil, mineral oil, peppermint oil" ], "purpose": [ "Purpose external analgesic external analgesic external analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a poison control center right away." ], "warnings": [ "Warnings ■ For external use only ■ Avoid getting into the eyes or on mucous membranes ■ Discontinue use if excessive irritation of the skin develops" ], "when_using": [ "When using this product ■ Do not apply to wound or damaged skin. ■ Do not bandage tightly" ], "spl_product_data_elements": [ "Zhenweilong Huoluo You External Analgesic Camphor Menthol Methyl Salicylate CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID DRAGON'S BLOOD EUCALYPTUS OIL MINERAL OIL PEPPERMINT OIL" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions ■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily. ■ Children under 12 years of age, consult a doctor before using ■ Do not use otherwise than as directed" ], "stop_use": [ "Stop use and ask a doctor if ■ Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ Pain persists for more than 10 days conditions ■ Redness is present ■ Conditions affect children under 12 years of age" ], "package_label_principal_display_panel": [ "Package Label image description" ], "indications_and_usage": [ "Uses For the temporary relief of minor aches and pains of muscles and joints associated with : ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains" ], "set_id": "10db86a5-b1d4-4f5f-877b-62f7dbca4ec0", "id": "263af858-1edb-47ab-8ef5-928a86695024", "active_ingredient": [ "Active Ingredients Camphor 10% Menthol 15% Methyl Salicylate 30%" ] }, { "effective_time": "20130114", "inactive_ingredient": [ "Water, Glycerin, Carrageenan, Ceratonia Siliqua Gum, Xanthan Gum, Butylene Glycol, Mineral Oil, Calcium Chloride, Etyl Alcohol, Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Hydrolyzed Collagen (0.1%), Coix Lacryma-Jobi Ma-yuen Seed Extract, Oryza Sativa (Rice) Bran Extract, Red Ginseng Extract, Argania Spinosa Kernel Oil, Adenosine, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Triethanolamine, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Houttuynia Cordata Extract, Artemisia Vulgaris Extract, Citrus Junos Fruit Extract, 1,2-Hexanediol, Caprylyl Glycol, Ethyl Hexanediol, Citrus Grandis (Grapefruit) Seed Extract, Bambusa Textilis Stem Extract, Pinus Palustris Leaf Extract, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Phenoxyethanol, Methylparaben, Chlorphenesin, Fragrance" ], "purpose": [ "for the treatment of skin" ], "keep_out_of_reach_of_children": [ "keep out or reach of the children" ], "warnings": [ "■ Avoid using on blemishes, pimples, irritated or sunburned skin. ■ Avoid using on skin which is sensitive to bandages, tapes or peel-off masks. ■ Stop using if skin becomes reddish, swollen or itchy, during and after usage. ■ Avoid contact with eyes directly." ], "spl_product_data_elements": [ "PiGe ll Real Skin Eye SUS SCROFA SKIN SUS SCROFA SKIN SUS SCROFA SKIN METHYLISOTHIAZOLINONE WATER GLYCERIN CARRAGEENAN CERATONIA SILIQUA WHOLE XANTHAN GUM BUTYLENE GLYCOL MINERAL OIL CALCIUM CHLORIDE ALCOHOL LYSINE HISTIDINE ARGININE ASPARTIC ACID THREONINE SERINE GLUTAMIC ACID PROLINE GLYCINE ALANINE VALINE METHIONINE ISOLEUCINE LEUCINE TYROSINE PHENYLALANINE CYSTEINE COIX LACRYMA-JOBI SEED OIL ORYZA SATIVA WHOLE PANAX GINSENG ROOT OIL ARGAN OIL ADENOSINE POLYOXYL 60 HYDROGENATED CASTOR OIL EDETATE DISODIUM TROLAMINE SCUTELLARIA BAICALENSIS ROOT TEA LEAF OIL HOUTTUYNIA CORDATA FLOWERING TOP ARTEMISIA VULGARIS ROOT CITRUS JUNOS FRUIT 1,2-HEXANEDIOL CAPRYLYL GLYCOL ETHOHEXADIOL CITRUS MAXIMA SEED BAMBUSA TEXTILIS STEM PINUS PALUSTRIS LEAF PROPYLPARABEN ETHYLPARABEN BUTYLPARABEN ISOBUTYLPARABEN PHENOXYETHANOL METHYLPARABEN CHLORPHENESIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "for external use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "attach biogel sheets around your eyes" ], "set_id": "10f47475-ebff-4002-9f24-bb6b5681bac3", "id": "405c1a1f-0683-4196-a98e-7ce4089417ae", "active_ingredient": [ "pork skin" ] }, { "effective_time": "20120802", "inactive_ingredient": [ "Inactive ingredients Water, Diisopropyl Adipate, Mineral Oil, Propylene Glycol, Petrolatum, Polyglyceryl-3 Methylglucose Distearate, Caprylyl Glycol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Benzyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Disodium EDTA, Camellia Sinensis Leaf Extract, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice Powder, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance." ], "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. May stain some fabrics." ], "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 prevent sunburn, not skin cancer or early aging. For external use only. Do not use on broken or damaged skin." ], "when_using": [ "When using this product Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Meijer SPF 8 AVOBENZONE, OCTOCRYLENE, OXYBENZONE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE WATER DIISOPROPYL ADIPATE MINERAL OIL PROPYLENE GLYCOL PETROLATUM CAPRYLYL GLYCOL CETYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE CARBOMER INTERPOLYMER TYPE A (55000 CPS) TROLAMINE BENZYL ALCOHOL COCOA BUTTER SHEA BUTTER COCONUT OIL SUNFLOWER OIL EDETATE DISODIUM GREEN TEA LEAF PEG-8 DIMETHICONE ALOE VERA LEAF CARROT BANANA OCTYLDODECANOL VITAMIN A PALMITATE SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID PHENOXYETHANOL METHYLPARABEN PROPYLPARABEN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply liberally 15 minutes before sun exposure reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: Ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "spl_unclassified_section": [ "Other Information protect this product from excessive heat and direct sun" ], "package_label_principal_display_panel": [ "Principle Display Panel Meijer SPF 8" ], "indications_and_usage": [ "Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "1150b6db-f3ef-4bdf-92f3-5dbc68fcb249", "id": "fb0af682-b24a-4c17-9522-f3bdb5c50182", "active_ingredient": [ "Active Ingredients Avobenzone 0.5% Octocrylene 2.0% Oxybenzone 1.5%" ] }, { "effective_time": "20091208", "inactive_ingredient": [ "Acrylates / Octylacrylamide Copolymer, Alcohol Denat, Alkyl Benzoate, Aloe Barbadensis Leaf extract, Fragrance, Mineral oil" ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings - For External Use Only - Flammable: Keep away from fire or flame - 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 this product keep out of eyes. Rinse with water to remove. - Stop use and ask a doctor if rash or irritation develops and lasts - Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F. - Keep out of reach of children." ], "spl_product_data_elements": [ "Total Suncare Sunscreen SPF 70 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE ALCOHOL ALOE VERA LEAF MINERAL OIL" ], "openfda": {}, "version": "1", "user_safety_warnings": [ "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. - May stain some fabrics - Avoid long term storage above 104 degrees F - For your protection, this bottle has an imprinted seal around the neck. Do not use if tamper evident seal is missing, tampered, broken, or destroyed." ], "package_label_principal_display_panel": [ "Total SunCare SUN SCREEN SPF 70 Contininous Spray Water Resistant BROAD SPECTRUM UVA/UVB PROTECTION clear rub-free free formula fast and easy coverage Net Contents 6 fl oz (177 ml) Expiration Date? Lot Number? Distributed By: Total Suncare LLC, 100 S. Washington Ave. Dunellen, NJ 08812, United States www.sunscreenus.com Product of China", "Total Suncare Sunscreen SPF 70" ], "indications_and_usage": [ "Uses - Helps prevent sunburn - Higher SPF gives more sunburn protection - Provides moderate protection against sunburn - Retains SPF after 40 minutes of activity in the water", "Directions - Apply evenly before sun exposure and as needed. - Hold can about 6in away from body and spray onto skin. - Do not spray onto face - spray into palm and smooth over face and neck. - Children under 6 months of age: ask a doctor. - Reapply as needed or after towel drying, swimming, or perspiring." ], "set_id": "1163ab15-be07-423c-8110-c039009b2241", "id": "3ff235f5-6093-482c-a0f8-20498228e063", "active_ingredient": [ "Active Ingredients Avobenzone 3 percent Homosalate 15 percent Octinoxate 5 percent Octyl Salicylate 5 percent Oxybenzone 5 percent" ] }, { "effective_time": "20150304", "inactive_ingredient": [ "Inactive ingredients: Aliphatic Hydrocarbon (Mineral Oil) Behenyl Methacrylate/Butyl Methacrylate Copolymer Epigallocatechin Gallate (Green Tea) Fragrance Isododecane Oryza Sativa (Rice) Bran Oil) Prunus Amygdalus Dulcis (Sweet Almond) Wax Sesamum Indicum (Sesame) Seed Oil" ], "purpose": [ "Purpose Antifungal" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Enter section text here" ], "warnings": [ "Warnings: For external use only. Do not use on children under 2 years of age. Avoid contact with the eyes. Do not use for diaper rash." ], "when_using": [ "When using this product for athlete's foot or ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.", "When using this product for the prevention of athlete's foot: If irritation occurs, discontinue use and consult a doctor." ], "spl_product_data_elements": [ "DermaTAF Antifungal Treatment TOLNAFTATE TOLNAFTATE TOLNAFTATE MINERAL OIL EPIGALLOCATECHIN GALLATE ISODODECANE RICE BRAN OIL SESAME OIL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. To prevent athlete's foot, clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and night). Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks least once daily. Supervise children in the use of this product." ], "package_label_principal_display_panel": [ "Package Label DermaTAF Antifungal Treatment Tolnaftate 1% Antifungal Solution 0.5 FL.OZ (15 mL) Manufactured for: DermaTAF, Inc. Lake Forest, CA 92630 Made in U.S.A. www.dermataf.com Questions or comments? 1-866-406-7926 Monday thru Friday 8:00AM to 5:00PM Western time label" ], "indications_and_usage": [ "Uses: For effective treatment of most athlete's foot and ringworm. Relieves itching, scaling, cracking, burning, redness, soreness, irritation. Prevents the recurrence of most athlete's foot (dermatophytosis) with daily use." ], "set_id": "11fc5b16-531c-4dee-892d-02bcd0b92ebf", "id": "87ea2223-0a64-4ea1-baa9-b75b9a9d74e5", "active_ingredient": [ "Active ingredients: Tolnaftate 1%" ] }, { "effective_time": "20150309", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, tapioca starch**, tartaric acid** ** may contain these ingredients" ], "purpose": [ "Purpose Laxative" ], "keep_out_of_reach_of_children": [ "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 ■ laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have ■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel movements that continues over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions Adverse Drug Event Call: (800) 616-2471" ], "spl_product_data_elements": [ "Senna Sennosides SENNOSIDES SENNOSIDES CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL STARCH, TAPIOCA TARTARIC ACID Light TCL;080" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Directions" ], "spl_unclassified_section": [ "Other Information ■ each tablet contains: calcium 25 mg, sodium 2 mg. VERY LOW SODIUM ■ store at 25°C (77°F) excursions permitted between 15°–30°C (59°–86°F) Compare to the active ingredient in Senokot ® Tablets * *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®. 191R Rev 01/10 Distributed by MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 Senna TABLETS Natural Vegetable Laxative For Gentle, Predictable Relief of Constipation Sennosides 8.6 mg EACH MAJOR® THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN Cardinal Health Zanesville, OH 43701 OI86350710" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Senna Tablets Sennosides 8.6 mg blister", "Package/Label Principal Display Panel Senna Tablets Sennosides 8.6 mg QTY 30 carton" ], "indications_and_usage": [ "Uses ■ relieves occasional constipation (irregularity) ■ generally causes a bowel movement in 6-12 hours" ], "set_id": "123af780-1165-4a00-8cbc-09cc5704fcba", "id": "d44f93cc-2e2c-4eab-bf97-7bdd504397d1", "active_ingredient": [ "Active ingredient Drug Facts Active Ingredient (in each tablet) Sennosides 8.6 mg" ] }, { "effective_time": "20100212", "inactive_ingredient": [ "Inactive Ingredients BHA, BHT, Caprylic/Capric Triglyceride, Cera Microcristallina, Flavor, Lanolin, Mineral Oil (Paraffinum Liquidum), Ozokerite, Petrolatum, Phenyl Trimethicone, Polyethylene, Propylparaben, PVP/Eicosene Copolymer, Tocopheryl Acetate" ], "purpose": [ "Purpose Sunscreen Skin Protectant" ], "warnings": [ "Warnings Keep out of eyes. Stop use if rash or irritation occurs. Keep out of reach of children. For external use only." ], "spl_product_data_elements": [ "Lip Balm OCTINOXATE OXYBENZONE DIMETHICONE OCTINOXATE OCTINOXATE BUTYLATED HYDROXYANISOLE BUTYLATED HYDROXYTOLUENE MEDIUM-CHAIN TRIGLYCERIDES LANOLIN MINERAL OIL PETROLATUM PHENYL TRIMETHICONE PROPYLPARABEN OXYBENZONE OXYBENZONE DIMETHICONE DIMETHICONE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply liberally before sun exposure and as needed." ], "package_label_principal_display_panel": [ "Package Label Package Label image of package label" ], "indications_and_usage": [ "Uses Helps prevent sunburn Temporarily protects and relieves chapped lips" ], "set_id": "1261d499-c2e1-473b-8407-bd0d0cf1c52a", "id": "f5b7726a-b83a-4df8-8642-d56ec01793c4", "active_ingredient": [ "Active Ingredient Octyl Methoxycinnamate 6% Oxybenzone 6% Dimethicone 1%" ] }, { "effective_time": "20091208", "inactive_ingredient": [ "Acrylates / Octylacrylamide Copolymer, Alcohol Denat, Alkyl Benzoate, Aloe Barbadensis Leaf extract, Fragrance, Mineral oil" ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings - For External Use Only - Flammable: Keep away from fire or flame - 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 this product keep out of eyes. Rinse with water to remove. - Stop use and ask a doctor if rash or irritation develops and lasts - Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F. - Keep out of reach of children." ], "spl_product_data_elements": [ "Total Suncare Sunscreen SPF 50 Plus AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE ALCOHOL ALOE VERA LEAF MINERAL OIL" ], "openfda": {}, "version": "2", "user_safety_warnings": [ "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. - May stain some fabrics - Avoid long term storage above 104 degrees F - For your protection, this bottle has an imprinted seal around the neck. Do not use if tamper evident seal is missing, tampered, broken, or destroyed." ], "package_label_principal_display_panel": [ "Total SunCare SUN SCREEN SPF 50+ Contininous Spray Water Resistant BROAD SPECTRUM UVA/UVB PROTECTION Clear rub-free free formula fast and easy coverage Net Contents 6 fl oz (177 ml) Expiration Date? Lot Number? Distributed By: Total Suncare LLC, 100 S. Washington Ave. Dunellen, NJ 08812, United States www.sunscreenus.com Product of China", "Total Suncare Sunscreen SPF 70" ], "indications_and_usage": [ "Uses - Helps prevent sunburn - Higher SPF gives more sunburn protection - Provides moderate protection against sunburn - Retains SPF after 40 minutes of activity in the water", "Directions - Apply evenly before sun exposure and as needed. - Hold can about 6in away from body and spray onto skin. - Do not spray onto face - spray into palm and smooth over face and neck. - Children under 6 months of age: ask a doctor. - Reapply as needed or after towel drying, swimming, or perspiring." ], "set_id": "12673b9b-d459-4b42-95f1-65bd47167191", "id": "e537fdaf-6b73-4ba3-842f-5577d60f6014", "active_ingredient": [ "Active Ingredients Avobenzone 3 percent Homosalate 15 percent Octinoxate 5 percent Octyl Salicylate 5 percent Oxybenzone 5 percent" ] }, { "effective_time": "20110919", "inactive_ingredient": [ "Inactive ingredients purified water USP, glyceryl stearate, isopropyl palmitate NF, light mineral oil NF, ozokerite, propylene glycol USP, stearyl alcohol NF, PEG-1500 stearate, poloxamer 188, propylene glycol monostearate NF, steareth-20, laureth-23, sodium metabisulfite NF, sodium lauryl sulfate NF, anhydrous citric acid USP, fragrance, methylparaben NF, dimethicone, propylparaben NF, edetate disodium, butylated hydroxyanisole" ], "purpose": [ "Purpose Skin Lightener" ], "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 inflamed or broken skin • On children under 12 years of age unless directed by a physician Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure If pregnant or breast-feeding, ask a healthcare professional before use. 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 • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure" ], "questions": [ "Questions? 1-800-900-6389 (24 hours a day, 7 days a week)" ], "spl_product_data_elements": [ "Esoterica Nighttime with Moisturizers hydroquinone hydroquinone hydroquinone water glyceryl monostearate isopropyl palmitate mineral oil ceresin propylene glycol stearyl alcohol polyethylene glycol 1500 poloxamer 188 steareth-20 laureth-23 sodium metabisulfite sodium lauryl sulfate anhydrous citric acid methylparaben dimethicone propylparaben edetate disodium butylated hydroxyanisole PROPYLENE GLYCOL MONOPALMITOSTEARATE" ], "ask_doctor": [ "Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor • For sensitive skin, test overnight on small area (inside elbow) • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a healthcare professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: MEDICIS The Dermatology Company ® Scottsdale, AZ 85256" ], "storage_and_handling": [ "Other information • Store at room temperature • Tamper-evident carton • Serious side effects may be reported to the phone number provided in the Questions? section below." ], "do_not_use": [ "Do not use • On inflamed or broken skin • On children under 12 years of age unless directed by a physician" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 70 g Carton Skin Lightener with Moisturizers NDC # 99207-290-02 E ESOTÉRICA ® ESOTÉRICA ® FADE CREAM NIGHTTIME With Moisturizers Net Wt. 2.5 oz (70 g) carton.jpg" ], "indications_and_usage": [ "Use Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptives." ], "set_id": "12adc34c-e65d-4679-b2c3-ab9ff5f615e8", "id": "8f190ff1-ad4c-4e71-9006-38aa705d381b", "active_ingredient": [ "Active ingredients Hydroquinone USP 2%" ] }, { "effective_time": "20130926", "inactive_ingredient": [ "Inactive Ingredients water, talc, C12-15 alkyl benzoate, caprylic/capric triglyceride, potassium cetyl phosphate, cyclopentasiloxane, glyceryl myristate, isononyl isononanoate, behenyl alcohol, mineral oil, glycerin, propylene glycol, microcrystalline cellulose, cellulose gum, phenoxyethanol, ethylhexylglycerin, nylon-12, fragance, triethanolamine, ammonium acryloyldimethyltaurate/VP copolymer, iron oxides, butylene glycol, allantoin, caffeine, ascorbic acid, disodium EDTA, tocopheryl actetate (vitamin E), BHT, hyaluronic acid." ], "instructions_for_use": [ "Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water-resistant sunscreen if swimming or sweating. 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." ], "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." ], "when_using": [ "Other Information protect the product in this container from excessive heat and direct sun" ], "spl_product_data_elements": [ "Skin Corrective Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen Light Medium Titanium Dioxide, Octinoxate TITANIUM DIOXIDE TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TALC WATER ALKYL (C12-15) BENZOATE TRICAPRIN POTASSIUM CETYL PHOSPHATE CYCLOMETHICONE 5 GLYCERYL MYRISTATE ISONONYL ISONONANOATE DOCOSANOL MINERAL OIL GLYCERIN PROPYLENE GLYCOL CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM PHENOXYETHANOL ETHYLHEXYLGLYCERIN NYLON-12 TROLAMINE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER FERRIC OXIDE RED BUTYLENE GLYCOL ALLANTOIN CAFFEINE ASCORBIC ACID EDETATE DISODIUM .ALPHA.-TOCOPHEROL ACETATE BUTYLATED HYDROXYTOLUENE HYALURONIC ACID" ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "Package/Label Principal Display Panel CAREONE ® bb cream skin perfector broad spectrum spf 15 sunscreen LIGHT/MEDIUM Helps brighten & even skin tone Moisturizes & renews UVA/UVB protection Compare to Garnier ® Skin Renew Miracle Skin Protector B.B. Cream SPF 15 2.5 FL OZ (75 mL) Our BB Cream (Beauty Balm Cream) is a hybrid formula that provides instant skin coverage together with advanced skin care, combining several beauty steps in one product. Skin Perfector is an innovative all-in-one product that gives instant results that can be both felt and seen. Skin is beautifully smooth and even with an \"airbrushed\" appearance. The lightweight texture blends perfectly into skin for a sheer perfect finish. The all-in-one formulation combines vitamin C with mineral pigments and intense moisturization for instantly transformed skin. Directions for Use: Gently smooth Skin Corrective Innovative Skin Perfector onto face and neck prior to exposure to the sun. Formula Essentials: Dermatology tested Non-comedogenic (won't clog pores) Gentle to skin Non-greasy Problem: Skin discolorations, dullness, blemishes and dryness can be caused by a number of different factors. It is difficult to find one product that will address all these factors at once. The Answer: The new Skin Corrective Innovative Skin Perfector instantly and effectively fulfils all your skincare expectations. Save time with this all-in-one multi-care product that combines instant skin coverage together with advanced skin care. Results: Instantly skin looks naturally more even-toned, smooth and radiant Radiance is renewed Complexion is brightened Skin tone is evened out and imprefections are blurred 24-hour hydration SPF15 sunscreen protects against the harmful effects of the sun *This product is not manufactured or distributed by Garnier ® , owner of the registered trademark Skin Renew . DISTRIBUTED BY FOODHOLD, U.S.A., LLC LANDOVER, MD 20785 1-877-846-9949 © 2013 S&S Brands, LLC MANUFACTURED IN ISRAEL Quality guaranteed or your money back. 6A418 D4 C1 Carton Label Carton 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": "12b6b69b-0700-413b-aa7e-57858bab2b29", "id": "12b6b69b-0700-413b-aa7e-57858bab2b29", "active_ingredient": [ "Active ingredient Octinoxate 4.0% Titanium Dioxide 2.1%" ] }, { "effective_time": "20130114", "inactive_ingredient": [ "Water, Glycerin, Carrageenan, Ceratonia Siliqua Gum, Xanthan Gum, Butylene Glycol, Mineral Oil, Calcium Chloride, Etyl Alcohol, Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Hydrolyzed Collagen (0.1%), Coix Lacryma-Jobi Ma-yuen Seed Extract, Oryza Sativa (Rice) Bran Extract, Red Ginseng Extract, Argania Spinosa Kernel Oil, Adenosine, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Triethanolamine, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Houttuynia Cordata Extract, Artemisia Vulgaris Extract, Citrus Junos Fruit Extract, 1,2-Hexanediol, Caprylyl Glycol, Ethyl Hexanediol, Citrus Grandis (Grapefruit) Seed Extract, Bambusa Textilis Stem Extract, Pinus Palustris Leaf Extract, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Phenoxyethanol, Methylparaben, Chlorphenesin, Fragrance" ], "purpose": [ "for the treatment of skin" ], "keep_out_of_reach_of_children": [ "keep out or reach of the children" ], "warnings": [ "■ Avoid using on blemishes, pimples, irritated or sunburned skin. ■ Avoid using on skin which is sensitive to bandages, tapes or peel-off masks. ■ Stop using if skin becomes reddish, swollen or itchy, during and after usage. ■ Avoid contact with eyes directly." ], "spl_product_data_elements": [ "PiGe ll Real Skin Mask Pack SUS SCROFA SKIN SUS SCROFA SKIN SUS SCROFA SKIN METHYLISOTHIAZOLINONE WATER GLYCERIN CARRAGEENAN CERATONIA SILIQUA WHOLE XANTHAN GUM BUTYLENE GLYCOL MINERAL OIL CALCIUM CHLORIDE ALCOHOL LYSINE HISTIDINE ARGININE ASPARTIC ACID THREONINE SERINE GLUTAMIC ACID PROLINE GLYCINE ALANINE VALINE METHIONINE ISOLEUCINE LEUCINE TYROSINE PHENYLALANINE CYSTEINE COIX LACRYMA-JOBI SEED OIL ORYZA SATIVA WHOLE PANAX GINSENG ROOT OIL ARGAN OIL ADENOSINE POLYOXYL 60 HYDROGENATED CASTOR OIL EDETATE DISODIUM TROLAMINE SCUTELLARIA BAICALENSIS ROOT TEA LEAF OIL HOUTTUYNIA CORDATA FLOWERING TOP ARTEMISIA VULGARIS ROOT CITRUS JUNOS FRUIT 1,2-HEXANEDIOL CAPRYLYL GLYCOL ETHOHEXADIOL CITRUS MAXIMA SEED BAMBUSA TEXTILIS STEM PINUS PALUSTRIS LEAF PROPYLPARABEN ETHYLPARABEN BUTYLPARABEN ISOBUTYLPARABEN PHENOXYETHANOL METHYLPARABEN CHLORPHENESIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "for external use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "attach biogel sheets to fit your face (upper sheet with eyes as the center, lower sheet with lips as the center)" ], "set_id": "13213a12-0a9b-4179-8da5-ae7e5ef4c3f7", "id": "a7e18cae-73f6-4c8c-8be8-19c75f087af4", "active_ingredient": [ "pork skin" ] }, { "effective_time": "20111114", "inactive_ingredient": [ "Inactive ingredients corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "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 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives skin reddening facial swelling rash asthma (wheezing) blisters shock If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcohol drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-356-9100" ], "spl_product_data_elements": [ "Conney Aspirin Aspirin ASPIRIN ASPIRIN CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSES MINERAL OIL STARCH, CORN TITANIUM DIOXIDE white ROUND TCL;011" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Adults and children: Take 1 or 2 tablets with water every 4 hours as needed. Do not (12 years and older) take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at room temperature 59º-86ºF (15º-30ºC) avoid excessive heat and humidity tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis" ], "package_label_principal_display_panel": [ "Conney Aspirin Label Conney ® Aspirin Pain Reliever Aspirin 325 mg. (NSAID) Aspirina 325 mg. (AINE) Lightly Coated Industrial Pack 500 (250 Packets of 2 Tablets) Carton Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache minor arthritis pain common cold menstrual cramps muscular aches backache toothache Temporarily reduces fever." ], "set_id": "132ccc3c-96e8-401a-a5ce-ce3fd5483461", "id": "55c3424a-afc5-4763-bf3e-fd8a8c4fd6e2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin (NSAID*) 325 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120621", "inactive_ingredient": [ "Inactive ingredients cyclomethicone, stearyl alcohol, mineral oil, talc, hydrogenated castor oil, PPG-14 butyl ether, fragrance, steareth-100, steareth-2, behenyl alcohol" ], "purpose": [ "Purpose Antiperspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call 1-800-228-7408 ." ], "spl_product_data_elements": [ "Speed Stick Apline Force Aluminum zirconium tetrachlorohydrex gly Aluminum zirconium tetrachlorohydrex gly Aluminum zirconium tetrachlorohydrex gly" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions apply to underarms only" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by COLGATE-PALMOLIVE CO. © New York, NY 10022 www.speedstick.com" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 85 g Stick Label GREAT CLEAN SCENT Speed stick ® Alpine Force™ Antiperspirant Deodorant NET WT 3 OZ (85 g) by MENNEN ® 36440 Principal Display Panel" ], "indications_and_usage": [ "Use reduces underarm wetness" ], "set_id": "132cefc8-da86-44cb-a211-52105d9744ca", "id": "6270219a-5ec6-4135-bcdd-e72088989b55", "active_ingredient": [ "Active ingredient Aluminum zirconium tetrachlorohydrex gly 15.3%" ] }, { "effective_time": "20150610", "inactive_ingredient": [ "Inactive Ingredients emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax" ], "purpose": [ "Purpose Anti-itch" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away" ], "warnings": [ "Warnings For external use only Do not use in eyes for treatment of diaper rash Stop use, ask a doctor if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days with use of other hydrocortisone products Keep out of reach of children. If ingested, contact a Poison Control Center right away" ], "spl_product_data_elements": [ "Hydrocortisone Hydrocortisone Hydrocortisone Hydrocortisone alcohol methylparaben mineral oil paraffin petrolatum propylparaben water white wax" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to affected area not more than 3 to 4 times dally children under 2: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use, ask a doctor if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days with use of other hydrocortisone products" ], "do_not_use": [ "Do not use in eyes for treatment of diaper rash" ], "package_label_principal_display_panel": [ "Principal Display Panel - Packet Label Anti-Itch Cream 0.9g (1/32 OZ) FIRST AID ONLY. www.FirstAidOnly.com Fairfield, CT 06824 1.800.835.2263 © 2015 Acme United Corporation. 810002-revA Principal Display Panel - Packet Label" ], "indications_and_usage": [ "Uses For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor." ], "set_id": "136150dd-b39d-42ea-a2ae-a5b4b15568d6", "id": "f37cb8e6-95b5-47f9-862c-ee0fcd00dc1f", "active_ingredient": [ "Active Ingredients Hydrocortisone 1.0%" ] }, { "effective_time": "20100218", "inactive_ingredient": [ "Inactive Ingredients: Cetearyl Alcohol, Mineral Oil, Paraffin, Sodium Lauryl Sulfate, Tocopheryl Acetate (vitamin E)." ], "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." ], "purpose": [ "Antiseptic" ], "warnings": [ "For external use only. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor." ], "spl_product_data_elements": [ "Thursday Plantation Tea Tree Antiseptic TEA TREE OIL TEA TREE OIL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: clean the affected area. apply small amount two or three times a day. may be covered with a sterile bandage." ], "stop_use": [ "Stop use and ask a doctor if redness, irritation or pain persists or increases, or if infection occurs." ], "storage_and_handling": [ "store below 86 degrees F." ], "package_label_principal_display_panel": [ "Thursday Plantation Australia's Original Tea Tree Antiseptic With Vitamin E Distributed By: Integria Healthcare Australia Pty Ltd 8 Clunies Ross Court Eight Mile Plains, QLD 4113 Australia www.thursdayplantation.com USA Phone: 1-866-273-0377 Made in Australia Tea Tree Antiseptic Ointment Label" ], "indications_and_usage": [ "Uses: protects cuts, abrasions, cracked dry skin, chapped lips and other minor wounds against infection." ], "set_id": "13902ab8-8562-4527-8ff9-82075002a41a", "id": "bbe03f6e-37db-49c2-8930-77727aba77bf", "active_ingredient": [ "Melaleuca Alternifolia (Tea Tree) Leaf Oil 5% ...... Antiseptic" ] }, { "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": "20120524", "inactive_ingredient": [ "Inactive ingredients adipic acid, blue #1 aluminum lake, dextrose, flavors, maltodextrin, mineral oil, polyethylene glycol, powdered cellulose, red #40 aluminum lake, talc, yellow #5 aluminum lake (tartrazine), yellow #6 aluminum lake" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor before use if you have kidney stones a calcium-restricted diet Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 15 tablets in 24 hours do not use the maximum dosage for more than 2 weeks Keep out of reach of children." ], "when_using": [ "When using this product do not take more than 15 tablets in 24 hours do not use the maximum dosage for more than 2 weeks" ], "questions": [ "Questions? 1-800-616-2471" ], "spl_product_data_elements": [ "Calcium Carbonate calcium carbon CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID DEXTROSE MALTODEXTRIN MINERAL OIL POLYETHYLENE GLYCOLS POWDERED CELLULOSE TALC L478 Cherry, lemon, lime, orange" ], "ask_doctor": [ "Ask a doctor before use if you have kidney stones a calcium-restricted diet" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions chew 2 - 4 tablets as symptoms occur, or as directed by a doctor" ], "package_label_principal_display_panel_table": [ "
Bottles of 60 NDC 54868-2399-1
" ], "storage_and_handling": [ "Other information each tablet contains: calcium 215 mg and magnesium 5 mg store at 20-25°C (68-77°F)" ], "package_label_principal_display_panel": [ "Principal Display Panel CALCIUM Antacid Tablets Regular Strength ANTACID/CALCIUM SUPPLEMENT Calcium Carbonate 500 mg Assorted Fruit Naturally & Artificially Flavored Bottles of 60 NDC 54868-2399-1 image of package label" ], "indications_and_usage": [ "Uses relieves heartburn sour stomach acid indigestion upset stomach associated with these symptoms" ], "set_id": "14021627-2204-4f7e-83da-d3d4059208ca", "id": "587ea494-b2d2-40d6-8c4f-a74e435d23ae", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredient (in each tablet) Calcium carbonate USP 500mg" ] }, { "effective_time": "20110214", "inactive_ingredient": [ "Inactive ingredients Mineral Oil, Petrolatum, Propylene Glycol, Ceresin, Paraffin, CI 77492 (and) CI 77491 (and) CI 77499, Zinc Stearate, Beeswax, Fragrance, Propylparaben, Benzyl Salicylate, Benzyl Alcohol, Hydroxycitronellal, Linalool, Coumarin, Citronellol, Geraniol, Eugenol, Amyl Cinnamal, Isoeugenol." ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children." ], "warnings": [ "Warnings For external use only." ], "when_using": [ "When using this product do not use in or near the eyes if it gets into eyes, rinse thoroughly with water" ], "questions": [ "Questions or comments? if you are in United States (305) 672-9486" ], "spl_product_data_elements": [ "Rayito de Sol Sunscreen SPF 18 Octisalate Oxybenzone Padimate O Octisalate Octisalate Oxybenzone Oxybenzone Padimate O Padimate O Mineral Oil Petrolatum Propylene Glycol Ceresin Paraffin Zinc Stearate YELLOW WAX Propylparaben Benzyl Salicylate Benzyl Alcohol Hydroxycitronellal LINALOOL, DL- Coumarin .BETA.-CITRONELLOL, (+/-)- Geraniol Eugenol .ALPHA.-AMYLCINNAMALDEHYDE Isoeugenol FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply generously 15 minutes before sun exposure. Children under six months of age: ask a doctor. Reapply every 2 hours or after swimming or sweating or anytime after towelling" ], "stop_use": [ "Stop use and ask a doctor if rash or irritation develops and lasts side effect occur. You may report side effect to FDA at 1-800-FDA-1088" ], "spl_unclassified_section": [ "If swallowed, seek medical attention or contact a Poison Control Center immediately." ], "storage_and_handling": [ "Other Information moderate sun protection product Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun. may stain clothing when freshly applied. Avoid contact with fabric or if fabric contact, launder within the hour" ], "package_label_principal_display_panel": [ "Principal Display Panel Rayito de Sol Sunscreen SPF 18 70 g/2.4oz Principal Display Panel" ], "indications_and_usage": [ "Uses Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn." ], "set_id": "1445cf5e-a21b-45ae-a0ca-bc5ea5e1d893", "id": "aa6f3dd2-74ab-4c29-b48d-83e9c1d964a9", "active_ingredient": [ "Active ingredient Octisalate 4% Oxybenzone 6% Padimate O 6%" ] }, { "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 %" ] }, { "pediatric_use": [ "Pediatric Use: Safety and efficacy in children have not been established." ], "effective_time": "20140603", "inactive_ingredient": [ "INGREDIENTS: Each gram of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% cream contains lidocaine hydrochloride 30 mg and hydrocortisone acetate 5 mg. Inactive ingredients include: aluminum sulfate, calcium acetate, cetyl alcohol, glycerin, hydrochloric acid, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan stearate, stearic acid and stearyl alcohol." ], "contraindications": [ "CONTRAINDICATIONS: Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with \"caine\" ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream and topical lidocaine should be used cautiously in those with impaired liver function as well as the very ill or very elderly and those with significant liver disease. Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream is contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation." ], "precautions": [ "PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. If extensive areas are treated, the possibility of systemic absorption exists. Systemic absorption of topical steroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroids applied to a large surface area, or under an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression. If noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid. Recovery of the HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled." ], "warnings": [ "WARNINGS: For external use only. Not for ophtalmic use. Product and used applicators could harm small children if chewed or swallowed. Individual tubes are NOT child resistant. Keep the product inside the child resistant blister until ready to use. KEEP PRODUCT AND USED APPLICATORS OUT OF THE REACH OF CHILDREN. Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not be ingested or applied into the mouth, inside of the nose or in the eyes. Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear. Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored." ], "pregnancy": [ "Use in Pregnancy: Teratogenic Effects: Pregnancy Category C. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother." ], "spl_product_data_elements": [ "Lidocaine HCl and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS HYDROCORTISONE ACETATE HYDROCORTISONE ALUMINUM SULFATE CALCIUM ACETATE CETYL ALCOHOL GLYCERIN HYDROCHLORIC ACID METHYLPARABEN MINERAL OIL PETROLATUM POLYSORBATE 60 PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM HYDROXIDE SORBITAN MONOSTEARATE STEARIC ACID STEARYL ALCOHOL" ], "description": [ "DESCRIPTION: Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream contains lidocaine hydrochloride 3% and hydrocortisone acetate 0.5% microdispersed in an AcidMantle vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl) and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-(11β)-. It has the following structural formula: IMAGE IMAGE" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: Apply Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream to the affected area(s) twice daily or as directed by a physician. The cap should be removed from the tube of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream and the applicator tip firmly screwed onto the end of the tube and tightened. Do not over-tightened. While holding the tube, squeeze the tube to fill the applicator until a small amount of cream shows and lubricate the end of the tip with cream. Gently insert the applicator tip with attached tube into anal area. Continue squeezing the body of the tube as it is moved around the areas of discomfort, and lastly, around and in the anal opening (if directed by physician). Do not completely insert the applicator and tube into the anus or insert deep into the rectum. Do not insert a loose applicator tip into the anus or rectum. Once application is completed, the tube and applicator tip should be gently removed from the area and disposed. Note that an adequate amount of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream for an application to the anal and peri-anal area will be applied through the applicator tip by gently squeezing the tube during application. Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition does not respond to repeated courses of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream, or should worsen, discontinue use and seek the advice of your physician." ], "adverse_reactions": [ "ADVERSE REACTIONS: During or immediately following application of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin." ], "mechanism_of_action": [ "CLINICAL PHARMACOLOGY: MECHANISM OF ACTION: Lidocaine is released from an AcidMantle vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The AcidMantle base can help maintain the pH balance of the skin." ], "how_supplied": [ "HOW SUPPLIED: Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream kit - NDC 0168-0479-14 contains 14 tubes, 1/4 oz (7 g) each and 14 single-use applicators. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 15°-30°C (59°-86°F). Protect from freezing. Manufactured for: E.FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 Manufactured by: Groupe PARIMA, Inc. Montreal, QC H4S 1X6 CANADA IL272A R6/09" ], "package_label_principal_display_panel": [ "PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER NDC 0168-0479-07 FOUGERA ® LIDOCAINE HCl 3% and HYDROCORTISONE ACETATE 0.5% CREAM For external use only Net Wt. 7 g Image tube label PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON NDC 0168-0479-14 FOUGERA ® LIDOCAINE HCl 3% and HYDROCORTISONE ACETATE 0.5% CREAM For external use only. Not for ophthalmic use. PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON", "PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON NDC 0168-0479-14 FOUGERA ® LIDOCAINE HCl 3% and HYDROCORTISONE ACETATE 0.5% CREAM For external use only. Not for ophthalmic use. PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON" ], "pharmacokinetics": [ "PHARMACOKINETICS: Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application duration of exposure, concentration and total dosage. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation in the liver. Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline. The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 g of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 g free base per mL. In the rhesus monkey, arterial blood levels of 18-21 g/mL have been shown to be threshold for convulsive activity. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma protein in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile." ], "indications_and_usage": [ "INDICATIONS: Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area." ], "set_id": "14d9a8c2-41d5-4cd2-81a8-e74625b273b9", "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted." ], "id": "07883905-5050-4fa8-a87a-adc7304ed432" }, { "effective_time": "20130321", "inactive_ingredient": [ "Inactive Ingredients: Beeswax, Disodium EDTA, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sodium Borate, Sorbitan Sesquioleate" ], "purpose": [ "Purpose External Analgesic, 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 this product do not get into eyes." ], "questions": [ "Questions or Comments? 1-800-241-6996 SUMMIT INDUSTRIES, INC PO Box 7329, Marietta, GA 30065 www.lantiseptic.com Item # 0610" ], "spl_product_data_elements": [ "Lanoguard Multi-Purpose MENTHOL, CALAMINE, ZINC OXIDE MENTHOL MENTHOL FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE YELLOW WAX EDETATE DISODIUM GLYCERIN LANOLIN METHYLPARABEN MINERAL OIL PETROLATUM PROPYLPARABEN WATER SODIUM BORATE SORBITAN SESQUIOLEATE" ], "ask_doctor": [ "Stop use and ask doctor if : condition worsens symptoms last more than 7 days or clear up and occur again within a few days." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions When practical, gently cleanse and dry area. Adults: Apply externally to affected area up to 6 times daily or after each incontinent episode or diaper change. Children under 12 years: Consult a doctor." ], "storage_and_handling": [ "Other Information Store at 15-30°C (59-86°F)" ], "package_label_principal_display_panel": [ "Image of representative container artwork LanoguardMPSO5goz.jpg Label" ], "indications_and_usage": [ "Uses A moisture barrier that prevents and helps protect skin irritations from urine diarrhea perspiration fistula drainage feeding tube site leakage wound drainage minor burns cuts scrapes itching" ], "set_id": "150e11d3-9b94-4184-a4a0-f849001f57ec", "id": "0c61edf7-96f9-4f42-9b8a-ea6c95daa8b8", "active_ingredient": [ "Active Ingredients Menthol 0.45% Calamine 2% Zinc Oxide 18%" ] }, { "effective_time": "20140219", "inactive_ingredient": [ "Inactive ingredients: water (Aqua), Carbopol 940, Stearic Acid, Glyceryl Monostearate, Mineral Oil, Cetearyl Alcohol, GE125 Emulsifying Agent, Methylparaben, Propyparaben, Triethanolamine, Tocopheryl Acetate, Cocoa Butter, Fragrance." ], "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. Do not use on deep puncture wounds." ], "when_using": [ "When using this product, do not get into eyes" ], "spl_product_data_elements": [ "Royal Petroleum (Cocoa Scent) PETROLATUM PETROLATUM PETROLATUM WATER STEARIC ACID GLYCERYL MONOSTEARATE MINERAL OIL CETOSTEARYL ALCOHOL METHYLPARABEN PROPYLPARABEN TROLAMINE CARBOMER HOMOPOLYMER TYPE C" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: apply as needed" ], "spl_unclassified_section": [ "Creamy petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Vitamin E to produce a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.", "*This product is not manufactured or distributed by Unilever, distributor of the registered trademark Vaseline (r) MADE IN CHINA DISTRIBUTED BY: Filo America P.O. Box 23592 Los Angeles, CA 90023 Questions or Concerns? 1.866.460.0322" ], "stop_use": [ "Stop use and ask doctor if condition worsens, Symptoms last more than 7 days clear up and occur again within a few days." ], "package_label_principal_display_panel": [ "cocoa scent" ], "indications_and_usage": [ "Temporarily protects minor: cuts scrapes burns Temporarily protects and helps relieve chapped or cracked skin Helps protect from the drying effects of wind and cold weather" ], "set_id": "155b0ce0-b930-4b8a-8c77-697677904b90", "id": "c3d4fca4-d621-465a-b3a9-f0bef5779d40", "active_ingredient": [ "DRUG FACTS Active Ingredient Purpose Petrolatum 30% Skin Protectant" ] }, { "effective_time": "20140214", "inactive_ingredient": [ "Inactive Ingredients Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Magnesium Sulfate, Phenoxyethanol, Methylparaben, Fragrance, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice." ], "purpose": [ "Purpose Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away." ], "warnings": [ "Warnings For external use only" ], "when_using": [ "When using this product do not get into eyes" ], "spl_product_data_elements": [ "Budpak Diaper Rash Zinc Oxide ZINC OXIDE ZINC OXIDE WATER MINERAL OIL PETROLATUM YELLOW WAX DIMETHICONE SORBITAN SESQUIOLEATE MICROCRYSTALLINE WAX PEG-30 DIPOLYHYDROXYSTEARATE MAGNESIUM SULFATE PHENOXYETHANOL METHYLPARABEN POTASSIUM HYDROXIDE PROPYLPARABEN .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged." ], "stop_use": [ "Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again in few days." ], "spl_unclassified_section": [ "Other Information Store at 20°to 25°C (68° to 77°F).", "PRINCIPAL DISPLAY PANEL Budpak Diaper Rash Cream Zinc Oxide 13% NET WT 1 OZ (28 g)" ], "package_label_principal_display_panel": [ "image of package label" ], "indications_and_usage": [ "Uses Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash. Helps seal out wetness" ], "set_id": "15c427f3-09a8-4514-b95a-cf966c574f3a", "id": "985046ac-f4ae-4c7a-881d-c2491a3a0f6a", "active_ingredient": [ "Active Ingredient Zinc Oxide 13%" ] }, { "effective_time": "20110602", "inactive_ingredient": [ "Inactive ingredients emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum" ], "purpose": [ "Active ingredients (in each gram) Purpose Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine HCl 10 mg External analgesic" ], "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 in the eyes over large areas of the body if you are allergic to any of the ingredients Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition persists for more than 7 days condition persists or gets worse condition clears up and occurs again within a few days a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call 1-877-745-6888 or visit www.myxcin-ab.com" ], "spl_product_data_elements": [ "ANTIBIOTIC PLUS PAIN RELIEF Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride Neomycin Sulfate Neomycin Polymyxin B Sulfate Polymyxin B Pramoxine Hydrochloride Pramoxine methylparaben mineral oil propylene glycol water petrolatum" ], "ask_doctor": [ "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age and older: clean the affected area apply one or more pumps of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: consult a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if condition persists for more than 7 days condition persists or gets worse condition clears up and occurs again within a few days a rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 20°- 25°C (68°-77°F) See card or pump for lot number and expiration date one pump contains .05±.01 grams" ], "do_not_use": [ "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each gram) Purpose
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine HCl 10 mg External analgesic
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 10 g Blister Pack New! MAXIMUM STRENGTH MYXCIN™-AB Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl FIRST AID ANTIBIOTIC CREAM Plus PAIN & ITCH RELIEF Neat Fingertip Dose Pump! Helps Heal, Protect & Relieve Itching in: Cuts Scrapes Burns ADVANCED WOUND MANAGEMENT ™ OVER 200 PUMPS 0.35 oz (10 g) Principal Display Panel - 10 g Blister Pack" ], "indications_and_usage": [ "Uses first aid to help prevent bacterial contamination and prevent infection and for the temporary relief of pain and itching in minor: cuts scrapes burns" ], "set_id": "15d6a038-7f8d-4f89-96f9-06c4deb2b0a1", "id": "ad7a427d-3ad0-4a47-8e2f-223b9242bd90", "purpose_table": [ "
Active ingredients (in each gram) Purpose
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine HCl 10 mg External analgesic
" ], "active_ingredient": [ "Active ingredients (in each gram) Purpose Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine HCl 10 mg External analgesic" ] }, { "effective_time": "20140510", "inactive_ingredient": [ "Other Ingredients: ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ALOE BARBADENSIS EXTRACT ASCORBIC ACID (VITAMIN C), C12-15 ALKYL BENZOATE, CASTOR OIL, COCOS NUCIFERA (COCONUT) OIL, FRAGRANCE, MINERAL OIL (PARAFFINUM LIQUIDUM), RETINYL PALMITATE (VITAMIN A), SD ALCOHOL 40-B (ALCOHOL DENAT.), TOCOPHERYL ACETATE (VITAMIN E)" ], "purpose": [ "PURPOSE: SUNSCREEN" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "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 AWAY FROM FACE TO AVOID BREATHING IT. CONTENTS UNDER PRESSURE- DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURES ABOUT 120 F. 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. FLAMMABLE: DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING." ], "spl_product_data_elements": [ "ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) ASCORBIC ACID C12-15 ALKYL BENZOATE CASTOR OIL ALOE VERA LEAF COCONUT OIL MINERAL OIL VITAMIN A PALMITATE ALCOHOL .ALPHA.-TOCOPHEROL ACETATE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS: SPRAY LIBERALLY AND SPREAD EVENLY BY HAND 15 MINUTES BEFORE SUN EXPOSURE. HOLD 4 TO 6 INCHES FROM THE SKIN TO APPLY. DO NOT SPRAY DIRECTLY INTO FACE. SPRAY ON HANDS THEN APPLY TO FACE. DO NOT APPLY IN WINDY CONDITIONS. USE IN A WELL-VENTILATED AREA. REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL DRYING, AT LEAST EVERY 2 HOURS." ], "package_label_principal_display_panel": [ "Aloe Up SPF 4 Tanning Oil Spray" ], "indications_and_usage": [ "INDICATIONS: HELPS PREVENT SUNBURN." ], "set_id": "1632dfb5-ab0c-4249-b0d9-68945272fee1", "id": "180b2294-eecd-427b-9e19-73a7be69851d", "active_ingredient": [ "ACTIVE INGREDIENTS: OCTINOXATE (2%) OXYBENZONE (2%)" ] }, { "effective_time": "20111215", "inactive_ingredient": [ "INACTIVE INGREDIENTS: MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL." ], "purpose": [ "PURPOSE SKIN PROTECTANT" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER." ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-910-6874" ], "spl_product_data_elements": [ "Healing PETROLATUM PETROLATUM PETROLATUM MINERAL OIL CERESIN LANOLIN ALCOHOLS PANTHENOL GLYCERIN .ALPHA.-BISABOLOL, (+/-)-" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY AS NEEDED." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK A DOCTOR IF CONDITION WORSENS OR SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE." ], "do_not_use": [ "DO NOT USE ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND RELIEVES CHAPPED OR CRACKED SKIN AND LIPS. HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER." ], "set_id": "16734504-fa93-4fff-bbcd-ad2b6342f55f", "id": "90ffc734-cc35-4d46-9278-6eaf4ccdbc96", "active_ingredient": [ "ACTIVE INGREDIENT PETROLATUM 41%" ] }, { "effective_time": "20131015", "inactive_ingredient": [ "Inactive ingredients edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan *may contain this ingredient" ], "purpose": [ "Purpose Nighttime sleep-aid" ], "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 with any other product containing diphenhydramine, even one used on skin 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 Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 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 avoid alcoholic drinks." ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "spl_product_data_elements": [ "NightTime Sleep Aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN LIGHT MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL P50;A99;S90" ], "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" ], "other_safety_information": [ "Other information store at 15°-30°C (59°-86°F)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by 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 sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness." ], "do_not_use": [ "Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal Display Panel ** Compare to the active ingredient in Unisom® SleepGels® Maximum Strength NightTime Sleep-Aid DIPHENHYDRAMINE HCl, 50 mg • LIQUID FILLED CAPSULES • SAFE, NON-HABIT FORMING Softgels ONE SOFTGEL PER DOSE **This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®. DISTRIBUTED BY ONPOINT, INC. 2 PARAGON DRIVE MONTVALE, NJ 07645 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.", "Package Label Live Better Maximum Strength NightTime Sleep Aid Softgel Diphenhydramine HCl 50 mg" ], "indications_and_usage": [ "Use for relief of occasional sleeplessness." ], "set_id": "16dc2588-c125-4e11-8077-2b42cd88424e", "id": "7c8a719a-2182-425f-8211-a7f91eb7b923", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient (in each softgel) Diphenhydramine HCl 50 mg" ] }, { "effective_time": "20150817", "inactive_ingredient": [ "Inactive ingredients lanolin oil, hydrogenated polyisobutene, ozokerite, octyldodecanol, limnanthes alba (meadowfoam) seed oil, VP/hexadecene copolymer, bis-diglyceryl polyacyladipate-2, mineral oil, copernica cerifera (carnauba) wax, cetyl lactate, polyethylene, paraffin, ricinus communis (castor) seed oil, ammonium glycyrrhizate, butylated hydroxytoluene, butylparaben, flavor, isobutylparaben, isopropylparaben, isopropyl titanium triisostearate, menthol, synthetic wax, tocopheryl acetate [vitamin E], iron oxides, mica, red 7 lake, titanium dioxide" ], "purpose": [ "Purpose Octinoxate - Sunscreen Octisalate - 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 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 prevent sunburn, not skin cancer or early skin aging. 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? Toll free 1-877-636-2677 MON-FRI 9 AM - 5 PM (EST) softlips.com" ], "spl_product_data_elements": [ "Softlips Tint Blossom Octinoxate, Octisalate OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE LANOLIN OIL HYDROGENATED POLYBUTENE (1300 MW) CERESIN OCTYLDODECANOL MEADOWFOAM SEED OIL MINERAL OIL CARNAUBA WAX CETYL LACTATE PARAFFIN CASTOR OIL AMMONIUM GLYCYRRHIZATE BUTYLATED HYDROXYTOLUENE BUTYLPARABEN ISOBUTYLPARABEN ISOPROPYLPARABEN ISOPROPYL TITANIUM TRIISOSTEARATE MENTHOL SYNTHETIC WAX (1200 MW) .ALPHA.-TOCOPHEROL ACETATE MICA D&C RED NO. 7 TITANIUM DIOXIDE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • children under 6 months: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "storage_and_handling": [ "Other information protect this product from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "Principal Display Panel Softlips Tint Blossom", "Principal Display Panel Softlips Tint Blossom" ], "indications_and_usage": [ "Uses • helps prevent sunburn" ], "set_id": "17e04ba5-957f-4d3d-9e67-cbc8581ae457", "id": "d7d3248e-3a3b-4b20-9ce9-b92522072173", "active_ingredient": [ "Active ingredients Octinoxate 7.5% Octisalate 5%" ] }, { "effective_time": "20151001", "inactive_ingredient": [ "Inactive Ingredients: Acrymalide, Amino Acids, Comfrey Leaf, Cetyl Alcohol, Diazolidinyl Urea, Dimethicone, Glucosamine, Methyl Paraben, MSM (Methylsulfonylmethane), Mineral Oil, Panthenol, Propylene Glycol, Propylparaben, Sodium Pyrrolidone Carboxylate, Stearic Acid, Stearyl Alcohol, Trolamine, Water." ], "purpose": [ "Uses Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children to avoid accidental poisoning." ], "warnings": [ "Warnings: For external use only. Do not use this product if safety seal is broken. Store in room temperature. Do not use on wounds or damaged skin. Do not apply in large quantities, particularly on raw and irritated or blistered areas. When using this product, avoid contact with eyes or mucus membranes. Use only as directed. Do not bandage tightly. Stop and ask doctor if condition worsen, if symptoms persist within 7 days or clear up and occur again within a few days. Stop use if excessive skin irritation occurs. If pregnant or breast feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "FAST RELIEF ARTROSAMIN Menthol, Methyl Salicylate MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID ACRYLAMIDE AMINO ACIDS, WHEAT CETYL ALCOHOL COMFREY LEAF DIAZOLIDINYL UREA DIMETHICONE DIMETHYL SULFONE GLUCOSAMINE METHYLPARABEN MINERAL OIL PANTHENOL PROPYLENE GLYCOL PROPYLPARABEN SODIUM PYRROLIDONE CARBOXYLATE STEARIC ACID STEARYL ALCOHOL TROLAMINE WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or mucous membranes. If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately." ], "spl_unclassified_section": [ "Manufactured for: Interfarma Corp. Miami, FL 33186." ], "package_label_principal_display_panel": [ "FAST RELIEF ARTROSAMIN For Temporarily Relieves minor aches and pains soreness, and stiffness associated with simple backaches strains, arthritis and rheumatism. Net Wt 8 oz (226g) Made in USA image description" ], "indications_and_usage": [ "Directions Apply to the affected area. Gently massage into the skin for a few seconds. Adults and children over 12 years of age: apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age need to consult a physician." ], "set_id": "17ee8850-4d78-4e41-84c7-a8f9e4c2cdaf", "id": "67b34aa9-c584-4578-83d3-de9ea61d72d5", "active_ingredient": [ "DRUG FACTS Active Ingredient: Purpose: Menthol 2.5%...................................External Analgesic Methyl Salicylate 15%......................External Analgesic" ] }, { "effective_time": "20140821", "inactive_ingredient": [ "Inactive Ingredients Water, Mineral Oil, Propylene Glycol, Glyceryl Distearate, Glyceryl Stearate, Microcrystalline Wax, Cetyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrahydroxypropyl Ethylenediamine, Phenoyethanol, Fragrance, Methylparaben, Benzatriazoyl Dodecyl p-Cresol, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben", "Inactive ingredients Water, Isopropyl Alcohol, Glycerin, Glyceryl Laurate." ], "purpose": [ "Purpose Skin Protectant", "Purpose Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.", "Keep out of reach of children. If swallowed , get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only", "Warnings Flammable. Keep away from fire or flame. For external use only." ], "when_using": [ "When using this product do not get into eyes", "When using this product, do not use in the eyes." ], "spl_product_data_elements": [ "Clorox CareConcepts Bed Bath and Hygiene Nitrile Non-Latex Gloves Clorox CareConcepts Aloe Moisturizing Dimethicone DIMETHICONE DIMETHICONE water MINERAL OIL PROPYLENE GLYCOL GLYCERYL DISTEARATE GLYCERYL STEARATE SE MICROCRYSTALLINE WAX CETYL ALCOHOL glycerin aloe (C10-C30)ALKYL METHACRYLATE ESTER POLYSORBATE 20 JOJOBA OIL EDETOL PHENOXYETHANOL METHYLPARABEN BENZOTRIAZOLYL DODECYL P-CRESOL ETHYLPARABEN BUTYLPARABEN PROPYLPARABEN ISOBUTYLPARABEN Clorox Care Concepts Hand Sanitizer alcohol ALCOHOL ALCOHOL water ISOPROPYL ALCOHOL glycerin GLYCERYL LAURATE Clorox CareConcepts No-Rinse Shampoo Clorox CareConcepts Bathing Wipes" ], "other_safety_information": [ "Other Information Store in a cool, dry place below 104 deg F (40 deg C)." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Apply liberally as often as needed.", "Directions Wet hands thoroughly with product and allow to dry without wiping." ], "stop_use": [ "Discontinue use and ask a doctor if irritate and redness develop. condition persists for more than 72 hours." ], "package_label_principal_display_panel": [ "Clorox Care Concepts Bed Bath and Hygiene Kit Nitrile Non-Latex Exam Gloves No-Rinse Shampoo Hand Sanitizer Bathing Wipes Aloe Moisturizing Lotion Skin Protectant BedBathHygKit" ], "indications_and_usage": [ "Use Helps prevent and temporarily protect dry, cracked, chafed skin.", "Use Hand sanitizer to decrease bacteria on the skin that potentially can cause disease" ], "set_id": "1868776f-5725-4afd-a25c-2b45ff65df24", "id": "e0042788-39e0-4817-a263-e48c84700d01", "active_ingredient": [ "Active Ingredient Dimethicone 1.25 percent", "Active ingredient Alcohol 67 percent" ] }, { "effective_time": "20121226", "inactive_ingredient": [ "Inactive ingredients *acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacitin, and triethyl citrate. *May also contain." ], "purpose": [ "Purpose Pain reliever" ], "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 Reye’s syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome , a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma(wheezing) shock Stomach bleeding warning : This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better allergic reaction occurs ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area If pregnant or breast- feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery . Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Aspirin Enteric Safety Coated Aspirin ASPIRIN ASPIRIN DIACETYLATED MONOGLYCERIDES ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 HYPROMELLOSES HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) FERRIC OXIDE YELLOW METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL 400 POLYSORBATE 80 POVIDONE PROPYLENE GLYCOL DIMETHICONE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE FD&C YELLOW NO. 6 E;HEART;81" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma" ], "other_safety_information": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) do not use if imprinted safety seal under cap is broken or missing †This product is not manufactured or distributed by Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not exceed recommended dosage drink a full glass of water with each dose adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours, unless directed by a doctor children under 12 years of age: consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast- feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery ." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better allergic reaction occurs ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the active ingredient in Aspirin Regimen Bayer® 81 mg † SEE NEW WARNINGS INFORMATION Enteric safety Coated/ Aspirin regimen** **Ask your doctor before taking this product on a regular basis Aspirin 81 mg adult low strength Pain reliever (NSAID)* Low Dose Distributed by: American sales company 4201 Walden avenue, Lancaster, NY 14086 www.care1.info", "Product Label Aspirin 81 mg CareOne" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief." ], "set_id": "1877bc57-e5e0-431f-9d60-df3204245a6c", "id": "49f1fd90-884c-486c-87d4-f390a5b04093", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti- inflammatory drug" ] }, { "effective_time": "20140404", "inactive_ingredient": [ "Inactive ingredients lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin image of carton" ], "purpose": [ "Purpose Guaifenesin.......................Expectorant Phenylephrine HCl..............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 immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage" ], "spl_product_data_elements": [ "Quality Choice Mucus Relief PE PE Guaifenesin/phenylephrine Guaifenesin Guaifenesin PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM LACTOSE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE MINERAL OIL POVIDONE MAGNESIUM SILICATE MAGNESIUM STEARATE RCCGPE;C27" ], "ask_doctor": [ "Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ excessive phlegm;mucus ■ difficulty in urination due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by 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 occurs ■ symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) ■ cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition ." ], "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 are uncertain whether your prescription drug contains an MAOI, ask a health professional." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive" ], "set_id": "18b3ac1b-408d-4658-8fc9-68ee1f05cefd", "id": "a3f885ab-8205-4c5d-8eac-ec6897cdd41a", "active_ingredient": [ "Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg" ] }, { "effective_time": "20130412", "inactive_ingredient": [ "INACTIVE INGREDIENTS Coptis Chinensis Root, Petrolatum, Mineral Oil, Stearic Acid, Glyceryl Monostearate, Sodium Dodecylbenzenesulfonate, Cetostearyl Alcohol, Water" ], "purpose": [ "PURPOSE ASTRINGENT VASOCONSTRICTOR LOCAL ANESTHETIC 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. (1-800-222-1222)" ], "warnings": [ "WARNINGS For external and/or intrarectal use only" ], "when_using": [ "WHEN USING THIS PRODUCT do not exceed the recommended daily dosage unless directed by a doctor" ], "questions": [ "QUESTIONS? Call 1 (626)285-1600 Monday through Friday, 9:00 a.m. to 5:30 p.m. P.S.T" ], "spl_product_data_elements": [ "JIDESHENG HEMORRHOID WITCH HAZEL, CARTHAMUS TINCTORIS FLOWER BED, CORYDALIS AMBIGUA TUBER, LONGICERA CAPRIFOLIUM CAPRIFOLIUM FLOWER WITCH HAZEL WITCH HAZEL CARTHAMUS TINCTORIUS FLOWER BUD CARTHAMUS TINCTORIUS FLOWER BUD CORYDALIS AMBIGUA TUBER CORYDALIS AMBIGUA TUBER LONICERA CAPRIFOLIUM FLOWER LONICERA CAPRIFOLIUM FLOWER COPTIS CHINENSIS ROOT PETROLATUM MINERAL OIL STEARIC ACID GLYCERYL MONOSTEARATE SODIUM DODECYLBENZENESULFONATE CETOSTEARYL ALCOHOL WATER" ], "ask_doctor": [ "ASK A DOCTOR BEFORE USE IF YOU HAVE heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland" ], "other_safety_information": [ "OTHER INFORMATION store at 20 -25°C (68 -77°F)" ], "openfda": {}, "version": "2899", "dosage_and_administration": [ "DIRECTIONS cleanse the affected area with an appropriate cleansing wipe or clean tissue paper when fist opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times only, especially at night, in the morning or after each bowel movement intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator after each use and replace cover also apply ointment to external area regular use provides continual therapy for relief of symptoms children under 12 year of age: 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 bleeding occurs condition worses or does not improve within 7 days introduction of applicator into the rectum causes additional pain" ], "package_label_principal_display_panel": [ "carton.jpg" ], "indications_and_usage": [ "USES helps relieve local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue and relieves burning temporarily provides a coating for relief of anorectal dosconforts temporarily protects the inflamed, irritated anorectal surface to help bowel movements less painful" ], "set_id": "18c2ae3f-ffdb-4ab0-b6b8-18683a9e687e", "id": "53fc5bec-808b-470d-ae08-14e1f3356581", "ask_doctor_or_pharmacist": [ "ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE presently taking a prescription drug for high blood pressure or depression" ], "active_ingredient": [ "ACTIVE INGREDIENTS WITCH HAZEL 1.25% CARTHAMUS TINCTORIUS FLOWER BUD 1.25% CORYDALIS AMBIGUA TUBER 1.25% LONICERA CAPRIFOLIUM FLOWER 0.5%" ] }, { "effective_time": "20150211", "inactive_ingredient": [ "Inactive Ingredients Glyceryl Monostearate Glyceryl Distearate Glycerin Stearic Acid Mineral Oil Petrolatum Paraffin Ceresin Beta Carotene Ethylparaben Sodium Lauryl Sulfate" ], "purpose": [ "Purpose Anti-Itch" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only. Avoid contact with the eyes. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "999 ITCH RELIEVING HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE GLYCERYL MONOSTEARATE GLYCERYL DISTEARATE GLYCERIN STEARIC ACID MINERAL OIL PETROLATUM PARAFFIN CERESIN BETA CAROTENE ETHYLPARABEN SODIUM LAURYL SULFATE" ], "other_safety_information": [ "Other Information Keep in a tightly closed container. Store at 8 to 30 ℃ (46-86℉) in a dry place away from sunlight. You may report serious side effects to: 1452 W. Holt Ave, Pomona, CA 91768" ], "openfda": {}, "version": "3102", "dosage_and_administration": [ "Directions Adult and children 2 years of age and older. Apply liberally to affected area not more than 5 times daily and 5-8 times per day for some severe cases or follow doctor's instruction." ], "pregnancy_or_breast_feeding": [ "Pregnant and children under 2 years of age. Do not use, consult a doctor." ], "stop_use": [ "Stop use and seek medical advice if Condition worsens. Symptoms persist for more than 7 days. Symptoms clear up and occur again within a few days. Excessive irritation of the skin develops." ], "spl_unclassified_section": [ "Manufactured By Guangdong CR. Shunfeng Pharmaceutical Co.; Ltd. Jinjuzu, Dalinag Street, Shunde District, Foshan, Guangdong, China 528300 Distributed by Master Herbs Inc. 1452 W. Holt Ave, Pomona, CA 91768 (866)487-8373" ], "package_label_principal_display_panel": [ "Drug Facts carton" ], "indications_and_usage": [ "Use For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: cosmetics, insect bites, psoriasis, eczema, seborrheic dermatitis." ], "set_id": "190a2618-f33d-4fe6-97e2-d145e88fdc2c", "id": "e99d3820-7f23-4d98-a41d-dcb141f80090", "active_ingredient": [ "ACTIVE INGREDIENTS Hydrocortisone 1.0%" ] }, { "effective_time": "20130219", "inactive_ingredient": [ "Inactive ingredients emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum" ], "purpose": [ "Active ingredients (each gram contains) Purpose Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine hydrochloride 10 mg External analgesic" ], "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 in the eyes over large areas of the body if you are allergic to any of the ingredients Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition persists or gets worse you need to use longer than 1 week symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call 1-866-923-4914" ], "spl_product_data_elements": [ "meijer Antibiotic Plus Pain Relief Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride Neomycin sulfate Neomycin Polymyxin B sulfate Polymyxin B Pramoxine hydrochloride Pramoxine methylparaben mineral oil propylene glycol water petrolatum" ], "ask_doctor": [ "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: clean the affected area and dry thoroughly apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage Children under 2 years of age: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY MEIJER DISTRIBUTION, INC. 2929 WALKER AVE NW GRAND RAPIDS, MI 49544" ], "stop_use": [ "Stop use and ask a doctor if condition persists or gets worse you need to use longer than 1 week symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date" ], "do_not_use": [ "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients" ], "active_ingredient_table": [ "
Active ingredients (each gram contains) Purpose
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine hydrochloride 10 mg External analgesic
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton meijer ™ Compare to NEOSPORIN ® + Pain Relief active ingredient* Maximum Strength AntibioticCream+PainRelief Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl NET WT 1/2 oz (14.2 g) PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton" ], "indications_and_usage": [ "Uses first aid to help prevent infection and for the temporary relief of pain or discomfort in minor: cuts scrapes burns" ], "set_id": "1925c6d1-0752-4815-969c-5d57e55dc510", "id": "f6763293-72fc-47df-82bf-805db5759cce", "purpose_table": [ "
Active ingredients (each gram contains) Purpose
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine hydrochloride 10 mg External analgesic
" ], "active_ingredient": [ "Active ingredients (each gram contains) Purpose Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine hydrochloride 10 mg External analgesic" ] }, { "effective_time": "20130102", "inactive_ingredient": [ "Inactive ingredients mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "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 in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use on deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if condition persists or gets worse a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call 1-866-923-4914" ], "spl_product_data_elements": [ "Walgreens Bacitracin Zinc Bacitracin Zinc Bacitracin Zinc Bacitracin mineral oil petrolatum" ], "ask_doctor": [ "Ask a doctor before use on deep or puncture wounds, animal bites, or serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions clean the affected area and dry thoroughly apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015" ], "stop_use": [ "Stop use and ask a doctor if condition persists or gets worse a rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information To open: unscrew cap, pull tab to remove foil seal store at room temperature see carton or tube crimp for lot number and expiration date" ], "do_not_use": [ "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton Bacitracin Zinc Ointment USP First Aid Antibiotic Ointment Well at Walgreens WALGREENS PHARMACIST RECOMMENDED‡ NET WT 1 OZ (28.4 g) Principal Display Panel - 28.4 g Tube Carton" ], "indications_and_usage": [ "Uses first aid to help prevent infection in minor cuts scrapes burns" ], "set_id": "194d9437-d65b-45c2-adad-b444f586bb48", "id": "0a506bf7-143e-4b59-a5f1-b6d9f7e62ae2", "active_ingredient": [ "Active ingredient (each gram contains) Bacitracin Zinc 500 units" ] }, { "effective_time": "20131129", "inactive_ingredient": [ "Inactive Ingredients Benzoic Acid, Butylated Hydroxy Anisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water." ], "purpose": [ "Purpose Antifungal" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use on children under 2 years of age except under the advice and supervision of a doctor. For external use only." ], "when_using": [ "When using this product avoid contact with eyes." ], "spl_product_data_elements": [ "Budpak Antifungal Miconazole Nitrate Miconazole Nitrate MICONAZOLE NITRATE MICONAZOLE BENZOIC ACID BUTYLATED HYDROXYANISOLE MINERAL OIL PEG-5 OLEATE PEGOXOL 7 STEARATE WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions wash affected area and dry thoroughly Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks if conditions persist longer, ask a doctor this product is not effective on the scalp or nails." ], "stop_use": [ "Stop using this product and ask a doctor irritation occurs there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch). do not use for diaper rash" ], "spl_unclassified_section": [ "Other information Store between 15ºC to 30º C (59ºF to 86º F) Lot No. & Exp. Date: see crimp of tube.", "PRINCIPAL DISPLAY PANEL Budpak Antifungal Cream Miconazole Nitrate 2% Antifungal for Athlete’s Foot and Jock Itch NET WT 0.5 OZ (14 g)" ], "package_label_principal_display_panel": [ "image of package label" ], "indications_and_usage": [ "Uses cures most athlete's foot, jock itch, and ringworm. relieves itching, burning, cracking, scaling and discomfort which accompany these conditions." ], "set_id": "1a156ca6-b290-4ab8-9efa-1ceebeabf7c2", "id": "37440f2f-0bc8-4799-8a1e-514b8d86a388", "active_ingredient": [ "Active Ingredient Miconazole Nitrate 2.0%" ] }, { "effective_time": "20140918", "inactive_ingredient": [ "Inactive Ingredients water, talc, C12-15 alkyl benzoate, caprylic/capric triglyceride, potassium cetyl phosphate, cyclopentasiloxane, glyceryl miristate, isononyl isononanoate, behenyl alcohol, mineral oil, glycerin, propylene glycol, microcrystalline cellulose, cellulose gum, phenoxyethanol, ethylhexylglycerin, nylon-12, fragrance, triethanolamine, ammonium acryloyldimethyltaurate/VP copolymer, iron oxides, butylene glycol, allantoin, caffeine, ascorbic acid, disodium EDTA, tocopheryl acetate (vitamin E), BHT, hyaluronic acid." ], "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." ], "when_using": [ "When using this product • keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Awaken Skin Perfector BB Broad Spectrum SPF 15 Sunscreen Light Medium Octinoxate and Titanium Dioxide OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER TALC ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES POTASSIUM CETYL PHOSPHATE CYCLOMETHICONE 5 GLYCERYL MYRISTATE ISONONYL ISONONANOATE DOCOSANOL MINERAL OIL GLYCERIN PROPYLENE GLYCOL CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM PHENOXYETHANOL ETHYLHEXYLGLYCERIN NYLON-12 TROLAMINE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER FERROUS OXIDE BUTYLENE GLYCOL ALLANTOIN CAFFEINE ASCORBIC ACID EDETATE DISODIUM .ALPHA.-TOCOPHEROL ACETATE BUTYLATED HYDROXYTOLUENE HYALURONIC ACID" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • Apply liberally 15 minutes before sun exposure. • Reapply at least every 2 hours. • Use water resistant sunscreen if swimming or sweating. • Children under 6 months of age: 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 a doctor • if rash occurs." ], "spl_unclassified_section": [ "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." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Awaken by Quality Choice ® BB cream light/medium Broad Spectrum SPF 15 Sunscreen Skin perfector With vitamin C & mineral pigments Renews, brightens, evens tone & hydrates Oil free, non-greasy *Compare to Garnier ® Skin Renew Miracle Skin Perfector B.B. Cream SPF15 2.5 FL OZ (75 mL) This BB Cream Light/Medium Broad Spectrum SPF 15 Sunscreen combines many steps of your daily beauty routine into one. It is lightweight, easy to use, and provides almost instant results that you can see and feel. This innovative formula is designed to deeply moisturize and help even skin tone, resulting in a smooth and unblemished appearance. The Results Skin instantly looks more even-toned, smooth and radiant. • Radiance is renewed. • Complexion is brightened. • Skin tone is evened out and imperfections are blurred. • 24-hour hydration. • SPF15 sunscreen protects against the harmful effects of the sun. Directions For Use Gently smooth onto face and neck prior to exposure to the sun. Formula Essentials: • Dermatology tested. • Non-Comedogenic (won’t clog pores). • Gentle to skin. • Non-greasy. Why is this product for me? Skin discolorations, dullness, blemishes and dryness can be caused by a number of different factors. It is difficult to find one product that will address all these factors at once. This product is not manufactured or distributed by Garnier ® , owner of the registered trademark Skin Renew Satisfaction Guaranteed Distributed by C.D.M.A., Inc. © 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300 Manufactured in ISRAEL 6A418 CD C1 Carton Label Carton 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": "1a776be8-78cc-4fd7-a969-99a0dae954a2", "id": "1a776be8-78cc-4fd7-a969-99a0dae954a2", "active_ingredient": [ "Active ingredients Octinoxate, 4.0% Titanium Dioxide, 2.1%" ] }, { "effective_time": "20111215", "inactive_ingredient": [ "INACTIVE INGREDIENTS: MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL." ], "purpose": [ "PURPOSE SKIN PROTECTANT" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER." ], "questions": [ "QUESTIONS? CALL 1-800-910-6874." ], "spl_product_data_elements": [ "Healing PETROLATUM PETROLATUM PETROLATUM MINERAL OIL CERESIN LANOLIN ALCOHOLS PANTHENOL GLYCERIN .ALPHA.-BISABOLOL, (+/-)-" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS APPLY AS NEEDED." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK A DOCTOR IF CONDITION WORSENS OR SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE." ], "do_not_use": [ "DO NOT USE ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND RELIEVES CHAPPED OR CRACKED SKIN AND LIPS. HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER." ], "set_id": "1a863cea-69b7-49b4-95c6-8f4a8faa8294", "id": "ab9cb71d-5692-477f-b1b5-f0e7fa064c84", "active_ingredient": [ "ACTIVE INGREDIENT PETROLATUM 41%" ] }, { "effective_time": "20150825", "inactive_ingredient": [ "Inactive ingredients mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "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" ], "when_using": [ "When using this product do not use in the eyes do not apply over large areas of the body" ], "spl_product_data_elements": [ "Bacitracin zinc bacitracin zinc BACITRACIN ZINC BACITRACIN MINERAL OIL PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "spl_unclassified_section": [ "For external use only", "Other information store at 15°- 30°C (59°- 86°F) lot number and expiration date: See crimp of tube or box You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.", "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 5/15 R7 8260300 0441" ], "stop_use": [ "Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse rash or other allergic reaction develops" ], "do_not_use": [ "Do not use if you are allergic to any of the ingredients" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the carton for Bacitracin Zinc Ointment, USP." ], "indications_and_usage": [ "Uses First aid to help reduce the risk of infection in minor: cuts scrapes burns" ], "set_id": "1aa0bd82-1589-46cd-a6b6-c26ed3413bf3", "id": "d02212b1-668c-4601-b980-56e5772074ae", "active_ingredient": [ "Active ingredient (in each gram) Bacitracin zinc, USP 500 units" ] }, { "effective_time": "20100107", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane, Isopropyl Palmitate, Stearyl Alcohol, Mineral Oil, Talc, Hydrogenated Castor Oil, Fragrance (Parfum) , Steareth-100, BHT." ], "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", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away" ], "warnings": [ "Warning For external use only" ], "questions": [ "Questions? call 1-866-DEGREE1" ], "spl_product_data_elements": [ "Degree Girl Friends Forever Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY ALUMINUM CATION" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "stop_use": [ "Stop use if rash or irritation occurs." ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.6 oz front Degree Girl Friends Forever 2.6 oz pdp front", "PDP 2.6 oz. back Degree Girl Friends Forever 2.6 oz pdp back" ], "set_id": "1afcd7c9-aa1d-4b31-845c-5251950f7b80", "id": "98692e5f-dbd1-4672-ad96-9f3d3ac714db", "active_ingredient": [ "Active ingredient Purpose Aluminum Zirconium Tetrachlorohydrex GLY (17.8%)...................anti-perspirant" ] }, { "effective_time": "20120427", "inactive_ingredient": [ "Other Ingredients: D.I. Water, Emulsifying Wax, Caprylic/Capric Triglyceride, Propylene Glycol, Mineral Oil, Triethanolamine, Carbomer and Imidazolidinyl urea." ], "purpose": [ "Purpose **AFR **AFR **AFR **AFR" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "WARNING: for external use only Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water Keep out of reach of children If condition worsens or does not improve after regular use of this product as directed or if local irritation or rash occurs, discontinue use and consult a physician. Use only if seal is unbroken." ], "questions": [ "Other Information: Any Questions? 1-800-644-8327 Website: BotanicChoice.com" ], "spl_product_data_elements": [ "Homeopathic Athletes Foot Carbonate of barium, black lead, pure flint, arbor vitae BARIUM CARBONATE BARIUM CATION GRAPHITE GRAPHITE SILICON DIOXIDE SILICON DIOXIDE THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG WATER CETOSTEARYL ALCOHOL POLYSORBATE 60 TRICAPRYLIN PROPYLENE GLYCOL MINERAL OIL TROLAMINE CARBOMER 934 IMIDUREA" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Cleanse skin, dry then apply twice daily to affected areas." ], "spl_unclassified_section": [ "Drug Facts", "*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the U.S. **The letters AFR indicate Athlete’s Foot Relief.", "Drug Facts (cont.)", "Distributed by: Indiana Botanic Gardens, Inc. 3401 W. 37th Avenue Hobart, IN 46342" ], "stop_use": [ "If condition worsens or does not improve after regular use of this product as directed or if local irritation or rash occurs, discontinue use and consult a physician." ], "package_label_principal_display_panel": [ "Homeopathic Athlete’s Foot Cream For treatment of mild skin irritation of the feet 1 oz. image of label" ], "indications_and_usage": [ "Uses: Apply to affected areas for the relief of mild skin irritation of the feet" ], "set_id": "1b36b706-e1e2-4ae1-85dc-d2a8c27c0e00", "id": "a6072d70-8a38-4af3-bb50-69ef78d4fb2d", "active_ingredient": [ "Active Ingredients Carbonate of Barium 10X H.P.U.S.* Black Lead 10X H.P.U.S.* Pure Flint 10X H.P.U.S.* Arbor Vitae 10X H.P.U.S.*" ] }, { "effective_time": "20101020", "inactive_ingredient": [ "COSMETIC INGREDIENTS: POLYBUTENE, HYDROGENATED POLYISOBUTENE, PARAFFINUM LIQUIDUM/MINERAL OIL/ HUILE MINERALE, ETHYLHEXYL PALMITATE, LANOLIN OIL, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, POLYETHYLENE, CALCIUM ALUMINUM BOROSILICATE, SILICA DIMETHYL SILYLATE, SILICA, SYNTHETIC FLUORPHLOGOPITE, ISOPROPYLPARABEN,BUTYLENE/ETHYLENE/STYRENE COPOLYMER, TOCOPHERYL ACETATE, PENTAERYTHRITYL TETRAISOSTEARATE, BUTYLPARABEN, ISOBUTYLPARABEN, PARFUM/FRAGRANCE, TRIBEHENIN, CARMINE, LINALOOL, BHT, ASCORBYL PALMITATE, RETINYL PALMITATE, TIN OXIDE, HYDROXYCITRONELLAL, SORBITAN ISOSTEARATE, HEXYL CINNAMAL, BUTYLENE GLYCOL, PALMITIC ACID, PHENOXYETHANOL, METHYLPARABEN, SODIUM CHONDROITIN SULFATE, PROPYLPARABEN, CAPRYLYL GLYCOL, ATELOCOLLAGEN, SODIUM HYALURONATE, HEXYLENE GLYCOL, PALMITOYL OLIGOPEPTIDE, ETHYLPARABEN. [MAY CONTAIN/PEUT CONTENIR/ : MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), DandC RED NO. 7 CALCIUM LAKE (CI 15850), DandC RED NO. 6 BARIUM LAKE (CI 15850), FDandC YELLOW NO. 5 ALUMINUM LAKE (CI 19140), DandC RED NO. 33 ALUMINUM LAKE (CI 17200), FDandC BLUE NO. 1 ALUMINUM LAKE CI 42090), FDandC YELLOW NO. 6 ALUMINUM LAKE (CI 15985), DandC RED NO. 27 ALUMINUM LAKE (CI 45410)]." ], "warnings": [ "WARNING: Stop use if skin rash occurs." ], "spl_product_data_elements": [ "Rimmel London Moisture Renew Lipgloss - Purple Rescue (335) Octinoxate, Octisalate OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE MINERAL OIL ETHYLHEXYL PALMITATE LANOLIN ETHYLENE ALUMINUM SILICON DIOXIDE ISOPROPYLPARABEN ETHYLENE .ALPHA.-TOCOPHEROL ACETATE, D- BUTYLPARABEN ISOBUTYLPARABEN TRIBEHENIN LINALOOL, (+/-)- BUTYLATED HYDROXYTOLUENE ASCORBYL PALMITATE VITAMIN A PALMITATE STANNIC OXIDE HYDROXYCITRONELLAL SORBITAN .ALPHA.-HEXYLCINNAMALDEHYDE BUTYLENE GLYCOL PALMITIC ACID PHENOXYETHANOL METHYLPARABEN SULFATE ION PROPYLPARABEN CAPRYLYL GLYCOL HYALURONATE SODIUM HEXYLENE GLYCOL ETHYLPARABEN MICA TITANIUM DIOXIDE IRON CALCIUM BARIUM" ], "openfda": {}, "version": "3", "package_label_principal_display_panel": [ "RIMMEL LONDON SPF 15 SUNSCREEN MOISTURE RENEW WITH COLLAGEN AND VITAMINS A, C and E CREAM LIPGLOSS 0.20 fl oz 6 ml Principal_Display_Panel Ingredients_Color_335 Use" ], "indications_and_usage": [ "USE: Helps prevent sunburn." ], "set_id": "1b85e240-0895-4fc2-93a4-466bed124942", "id": "9d6480af-0d10-40b9-b599-b0007df50adf", "active_ingredient": [ "Active Ingredients: Octinoxate 7.5%, Octisalate 2.0%." ] }, { "effective_time": "20090916", "inactive_ingredient": [ "Inactive Ingredients POLYBUTENE, MINERAL OIL, ETHYLHEXYL PALMITATE, PARAFFIN, CERESINE, MICROCRYSTALLINE WAX, BEES WAX, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN, D AND C BLUE NO. 1 AL LAKE, TITANIUM DIOXIDE" ], "purpose": [ "Uses - Helps prevent sunburn - Higher SPF gives more sunburn protection - Helps prevent and temporarily protects dry, chapped or windburned lips" ], "keep_out_of_reach_of_children": [ "If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "For Add'l Info Call: 1.800.999.9322 or Visit hiyamints.com or webbcandy.com" ], "spl_product_data_elements": [ "Webb Candy Peppermint Candy Cane Lip Balm OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE OCTISALATE OCTISALATE MINERAL OIL ETHYLHEXYL PALMITATE PARAFFIN WAX, YELLOW METHYLPARABEN PROPYLPARABEN FD&C BLUE NO. 1 TITANIUM DIOXIDE" ], "ask_doctor": [ "Stop use and ask a doctor if - rash or irritation develops and lasts - condition worsens or does not improve within 7 days" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions - Apply liberally before sun exposure and as needed - Children under 6 months of age, ask a doctor" ], "information_for_patients": [ "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": [ "Webb Candy Peppermint Lip Balm" ], "set_id": "1b878afb-6791-4188-bdee-52e5772c810d", "id": "65f7c57b-3787-4c7a-9399-a1f858045109", "active_ingredient": [ "Active ingredients Purpose Octyl Methoxycinnamate 7.5 percent Sunscreen Oxybenzone 3.0 percent Sunscreen Octyl Salicylate 2.0 percent Sunscreen" ] }, { "effective_time": "20100404", "inactive_ingredient": [ "Inactive Ingredients SD Alcohol 40, Mineral Oil, C12-15 Alkyl Lactate, Ethylhexyl Benzoate, Trimethylolpropane Tricaprylate/ Tricaprate, Cetearyl Ethylhexanoate, Dicaprylyl Carbonate, Acrylates/ Octylacrylamide Copolymer, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Caprylyl Glycol, Dimethyl Capramide, Tocopherol (Vitamin E), Retinyl Palmitate (Vitamin A), Aloe Barbadensis Leaf Extract, 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 Do not spray directly into face Flammable: do not use near heat, flame, or while smoking When using this product avoid spraying in eyes. If contact occurs, rinse thoroughly with water. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Stop use and ask a doctor if irritation or rash develops 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 spraying in eyes. If contact occurs, rinse thoroughly with water. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F." ], "questions": [ "Questions or Comments? Call 1-800 SafeSun, Mon-Fri MADE IN USA Distributed by: SUN PHARMACEUTICALS, LLC SHELTON, CT 06484" ], "spl_product_data_elements": [ "Banana Boat Deep Tanning Dry SPF 4 Avobenzone and Octocrylene and Oxybenzone AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE MINERAL OIL DICAPRYLYL CARBONATE GRAPE SEED OIL COCONUT OIL CAPRYLYL GLYCOL ALPHA-TOCOPHEROL VITAMIN A PALMITATE ALOE VERA LEAF" ], "description": [ "Purpose Sunscreen" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions apply generously and evenly to all areas 15 minutes before sun exposure spray on hands to apply to face use in well-ventilated area reapply at frequent intervals and after swimming or towel drying ask a doctor before use on children under six months of age" ], "spl_unclassified_section": [ "Drug Facts", "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. May stain some fabrics." ], "stop_use": [ "Stop use and ask a doctor if irritation or rash develops" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL CLEAR UltraMist ® BANANA BOAT ® deep TANNING DRY OIL Continuous Spray Sunscreen SPF/UVB 4 AvoTriplex TM With UVA 3-Way Protection TM Sun-Tested, Sun- Proven TM Fast & Even Coverate Coconut & Grape Seed Oils Very Water Resistant 6 FL. OZ. (177 mL ) PRINCIPAL DISPLAY PANEL Banana Boat Deep Tanning Dry Oil SPF 4" ], "indications_and_usage": [ "Use helps prevent sunburn" ], "set_id": "1bea9b15-6e7e-4050-9e6e-e69ed8e9e97b", "id": "8765dc76-e236-49e9-a99c-de6d2da684b7", "active_ingredient": [ "Active Ingredients Avobenzone 0.005mL / 1mL Octocrylene 0.01mL / 1mL Oxybenzone 0.005mL / 1mL" ] }, { "effective_time": "20110726", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium*, hypromellose, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, propylene glycol*, starch, titanium dioxide* * may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "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 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcohol drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-835-2263" ], "spl_product_data_elements": [ "Physicians Care Aspirin Aspirin ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN white ROUND 44;157;aspirin" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at room temperature 59º-86ºF (15º-30ºC) avoid excessive heat and humidity tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis" ], "package_label_principal_display_panel": [ "Principal Display Panel", "116R Physicians Care-Aspirin 325 mg Label Physicians Care® ASPIRIN Fever Reducer and Pain Reliever (NSAID) Pull To Open COATED TABLETS Compare Active ingredients to: Bayer® Registered Trademark of Bayer AG Tamper-Evident Packets of 2 Tablets See new warnings information Physicians Care® Registered Trademark of ACME UNITED Corporation 50 PACKETS (2 Tablets 325 Mg Each) 116R Physicians Care-Aspirin 325 mg Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache minor arthritis common cold menstrual cramps muscular aches backache toothache Temporarily reduces fever." ], "set_id": "1bfea312-ff95-4237-96dd-4fd9f8e581e5", "id": "ec1e2751-3c19-4e0a-9a16-dfa0080615fc", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin (NSAID*) 325 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20130422", "inactive_ingredient": [ "Inactive Ingredients: Cyclopentasiloxane, Stearyl alcohol, Hydrogenated Castor Oil, Dipropylene Glycol Dibenzoate, Fragrance, PEG-8 Distearate, Silica, Aluminum Strach Octenyl Succinate, Mineral Oil, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract" ], "purpose": [ "Purpose: Antiperspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings: For external use only. Do not use on broken skin. Stop us if rash or irritation occurs. Ask a doctor before use if you have kidney disease. Stop use and ask a doctor if rash or irritation occurs. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions?: Call 022-67464241 or email us at zodhitacare@zodhita.com" ], "spl_product_data_elements": [ "ZUSKA VIVA ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY CYCLOMETHICONE 5 STEARYL ALCOHOL HYDROGENATED CASTOR OIL DIPROPYLENE GLYCOL DIBENZOATE PEG-8 DISTEARATE SILICON DIOXIDE ALUMINUM STARCH OCTENYLSUCCINATE MINERAL OIL COCONUT OIL ALOE VERA LEAF" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply to underarms only." ], "package_label_principal_display_panel": [ "Place holder text image of canister label" ], "indications_and_usage": [ "Use: reduces underarm perspiration" ], "set_id": "1c064f1d-179b-4979-bc90-c5f2eb98ced3", "id": "de59a033-f0e3-4fe6-8f26-c0891096390a", "active_ingredient": [ "Active Ingredients: Aluminum Zirconium Trichlorohydrex Gly (18%)" ] } ] }