{ "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": 16 } }, "results": [ { "effective_time": "20120711", "inactive_ingredient": [ "Inactive ingredients Water, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Potassium Cetyl Phosphate, Styrene/Acrylates Copolymer, Polysilicone-15, Phenoxyethanol, Glycerin, Acrylates/C12-12 Alkyl Methacrylate Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Benzoate, Squalane, Acrylates/Steareth-20 Methacrylate Copolymer, Acrylates Copolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Ethylhexylglycerin, Tocopheryl Acetate, Polysorbate 60, Ascorbyl Palmitate, Sodium Phytate, Behenyl Alcohol, Glyceryl Stearate, Palmitic Acid, Steraic Acid, Cetyl Alcohol, Lauryl Alcohol, Myristyl Alcohol, Hydrogenated Soybean Oil, Lecithin, Vaccinium Angustifolium (Blueberry) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Ethyl Acetate, Ethyl Butyrate, Isoamyl Butyrate, Metyl Anthranilate, Methylbenzyl Acetate." ], "purpose": [ "Purpose Sunscreen" ], "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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Contact our Sun Specialists for Questions: 877.564.7330" ], "spl_product_data_elements": [ "Save Face A.M. Moisturizer Broad Spectrum Avobenzone, Octinoxate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER C12-15 ALKYL BENZOATE DIETHYLHEXYL 2,6-NAPHTHALATE POTASSIUM CETYL PHOSPHATE POLYSILICONE-15 PHENOXYETHANOL GLYCERIN HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SODIUM BENZOATE SQUALANE AMINOMETHYLPROPANOL ALOE VERA LEAF ETHYLHEXYLGLYCERIN .ALPHA.-TOCOPHEROL ACETATE POLYSORBATE 60 ASCORBYL PALMITATE PHYTATE SODIUM DOCOSANOL GLYCERYL STEARATE SE PALMITIC ACID STEARIC ACID CETYL ALCOHOL LAURYL ALCOHOL MYRISTYL ALCOHOL HYDROGENATED SOYBEAN OIL LOWBUSH BLUEBERRY SUNFLOWER SEED ETHYL ACETATE ETHYL BUTYRATE ISOAMYL BUTYRATE METHYL ANTHRANILATE METHYLBENZYL ACETATE" ], "warnings_and_cautions": [ "Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF 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." ], "openfda": {}, "version": "40011", "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 when exposed to sunlight. Children under 6 months: Ask a doctor." ], "storage_and_handling": [ "Other Protect the product in this container from excessive heat and direct sun." ], "package_label_principal_display_panel": [ "Package Label Principal Display Panel image of tube" ], "indications_and_usage": [ "Use 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": "254b1a20-935a-44cd-88da-8359cd331c0f", "id": "f91c4973-301e-4f6a-b966-b426c225a66f", "active_ingredient": [ "Active ingredients Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 2.79%" ] }, { "effective_time": "20100108", "drug_interactions": [ "Drug Interactions Beta adrenergic blockers and MAOIs may potentiate the pressor effect of phenylephrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias. Do not prescribe this product for use in patients that are now taking a prescription MAOI (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 14 days after stopping MAOI drug therapy." ], "geriatric_use": [ "Geriatric Use Patients aged 60 and older are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and death. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy." ], "precautions": [ "PRECAUTIONS Information for Patients Patient consultation should include the following information regarding proper use of this medication: • Do not take more medication than the amount recommended. • Do not take MAOIs while taking this medication. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; not doubling doses. • This medication should be stored in a tight, light-resistant container at temperatures between 20°- 25°C (68°- 77°F), see USP Controlled Room Temperature. • Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Drug Interactions Beta adrenergic blockers and MAOIs may potentiate the pressor effect of phenylephrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias. Do not prescribe this product for use in patients that are now taking a prescription MAOI (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 14 days after stopping MAOI drug therapy. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals and humans. Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefits to the mother justify the potential risks to the infant. Nursing Mothers Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers. Pediatric Use Safety and effectiveness of this product in pediatric patients below the age of 6 years have not been established. Very young children may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines like phenylephrine. Geriatric Use Patients aged 60 and older are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and death. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy." ], "description": [ "DESCRIPTION Each teaspoonful (5mL) contains: Carbetapentane Citrate . . . . . . . . . . . . . 30 mg Phenylephrine HCl . . . . . 10 mg Brompheniramine Maleate . . . . . . . . . . . . . 6 mg" ], "storage_and_handling": [ "Storage and Handling Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Store at controlled room temperature, 20°- 25°C (68°- 77°F), See USP Controlled Room Temperature. Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088. Rx Only Manufactured for: Capellon Pharmaceuticals, LLC Fort Worth, TX 76118 500391 Rev. 09/09" ], "indications_and_usage": [ "INDICATIONS AND USAGE For the temporary relief of symptoms associated with the common cold, allergies, hay fever, sinusitis, influenza, bronchitis and other respiratory illnesses. Relieves cough due to throat and bronchial irritation as may occur with the common cold, inhaled irritants, or related conditions." ], "set_id": "3734ea65-1c6d-4a85-9472-0f8a712683b4", "id": "1be84d03-4892-435a-8247-fa862138881a", "pediatric_use": [ "Pediatric Use Safety and effectiveness of this product in pediatric patients below the age of 6 years have not been established. Very young children may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines like phenylephrine." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS benzoic acid, bubblegum flavor, citric acid, edetate disodium USP, glycerin, propylene glycol, purified water, saccharin sodium, sodium citrate dihydrate and sorbitol. Carbetapentane Citrate is an antitussive which occurs as a white crystalline powder. It is freely soluble in water, chloroform; soluble in alcohol, acetone, ethyl acetate. It is practically insoluble in ether, petr ether, benzene. The chemical name is 1-Phenylcyclopentanecarboxylic Acid 2-(2-Diethylaminoethoxy)ethyl Ester Citrate Salt. The chemical structure of Carbetapentane Citrate is as follows: C 20 H 31 NO 3 • C 6 H 8 O 7 M.W. 525.59 Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is (R)-3-hydroxy-α-[(methylamino)methyl]benzenemethanol hydrochloride and has the following structural formula: C 9 H 13 NO 2 • HCI M.W. 203.67 Brompheniramine maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine, γ-(4-bromophenyl)- N,N -dimethyl-, (±)-,(Z)-2-butenedioate (1:1) The chemical structure of Brompheniramine Maleate is as follows: C 16 H 19 BrN 2 • C 4 H 4 O 4 M.W. 435.31" ], "contraindications": [ "CONTRAINDICATIONS Trexbrom( Liquid is contraindicated in patients hypersensitive to any of its ingredients. It is also contraindicated in patients with severe hypertension or severe coronary artery disease, or in those receiving monoamine oxidase inhibitor (MAOI) therapy. Antihistamines should not be used to treat lower respiratory tract conditions including asthma." ], "warnings": [ "WARNINGS Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. DO NOT EXCEED RECOMMENDED DOSAGE ." ], "pregnancy": [ "Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefits to the mother justify the potential risks to the infant." ], "nursing_mothers": [ "Nursing Mothers Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers." ], "spl_product_data_elements": [ "Trexbrom Carbetapentane Citrate / Phenylephrine HCl / Brompheniramine Maleate PENTOXYVERINE CITRATE PENTOXYVERINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE BENZOIC ACID CITRIC ACID MONOHYDRATE EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SORBITOL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults and children 12 years and older: 1 teaspoon (5 mL). Children 6 to 12 years of age: 1/2 teaspoon (2.5 mL). May be repeated every 6 hours as required for relief. Not to exceed 4 doses in 24 hours. In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate." ], "adverse_reactions": [ "ADVERSE REACTIONS Mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs, may occur. Nervousness, excitability, restlessness, dizziness, weakness, and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea, and/or vomiting. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias, and cardiovascular collapse with hypotension." ], "how_supplied": [ "HOW SUPPLIED Trexbrom( Liquid is a clear, sugar free, alcohol free, bubble gum flavored liquid. Available in 10 mL sample bottles (NDC 64543-500-10), 4 oz. Bottles (NDC 64543-500-04), and 16 oz. Bottles (NDC 64543-500-16). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Storage and Handling Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Store at controlled room temperature, 20°- 25°C (68°- 77°F), See USP Controlled Room Temperature. Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088. Rx Only Manufactured for: Capellon Pharmaceuticals, LLC Fort Worth, TX 76118 500391 Rev. 09/09" ], "information_for_patients": [ "Information for Patients Patient consultation should include the following information regarding proper use of this medication: • Do not take more medication than the amount recommended. • Do not take MAOIs while taking this medication. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; not doubling doses. • This medication should be stored in a tight, light-resistant container at temperatures between 20°- 25°C (68°- 77°F), see USP Controlled Room Temperature. • Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 1: Trexbrom 10 mL sample label Figure 2: Trexbrom 4 oz product label Figure 3: Trexbrom 16 oz. product label 1be84d03-figure-01 1be84d03-figure-02 1be84d03-figure-03 1be84d03-figure-04 1be84d03-figure-05 1be84d03-figure-06" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Carbetapentane Citrate is a centrally acting non-narcotic antitussive agent with mild atropine-like antisecretory activity; used in the treatment of cough associated with upper respiratory infections. Phenylephrine Hydrochloride is a nasal decongestant, and a potent postsynaptic alpha (α)-receptor agonist with little effect on the beta (β)-receptors of the heart. Phenylephrine HCl has no effect on the (β)-adrenergic receptors of the bronchi or peripheral blood vessels. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Therapeutic doses of phenylephrine HCl may cause vasoconstriction. It increases resistance and, to a lesser extent, decreases the capacitance of blood vessels. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Local vasoconstriction and hemostasis occur following infiltration of phenylephrine HCl into tissues. The main effect of phenylephrine HCl on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of the heart which can cause arrhythmias. Cardiac output is decreased slightly. Phenylephrine HCl increases the work of the heart by increasing peripheral arterial resistance. Phenylephrine HCl has a mild central stimulant effect. Following oral administration of phenylephrine HCl, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. Brompheniramine Maleate is classified as an alkylamine antihistamine. This class is among the most active histamine antagonists and is generally effective in relatively low milligram doses. Alkylamines cause a lesser degree of drowsiness and sedation than the phenothiazine antihistamines and hence may be more suitable for daytime use. It should be noted, however, that patients taking alkylamine antihistamines may experience some degree of drowsiness." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals and humans." ], "overdosage": [ "OVERDOSAGE Signs and Symptoms: Central effects include restlessness, dizziness, tremor, hyper-reactive reflexes, talkativeness, irritability, and insomnia. Cardiovascular and renal effects include difficulty in urination, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, anorexia, nausea, vomiting, diarrhea, and abdominal cramps. Recommended Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method; however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administrated as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive." ] }, { "effective_time": "20130919", "inactive_ingredient": [ "Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "purpose": [ "Anti-fungal" ], "keep_out_of_reach_of_children": [ "Do not use on children under 2 years of age unless directed by a doctor. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes. Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Fiore Rx CranApple Crush Antifungal Nail Polish Undecylenic Acid Undecylenic Acid Undecylenic Acid Butyl Acetate Ethyl Acetate Pyroxylin POLYESTER-10 Acetyltributyl Citrate Isopropyl Alcohol DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER Bentoquatam D&C Red No. 7 Butyl Alcohol Silicon Dioxide D&C Red No. 6 Benzoresorcinol PROPOLIS WAX Trimethylpentanediyl Dibenzoate D&C Red No. 34" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes." ], "package_label_principal_display_panel": [ "Fiore Rx Drug Facts Label.jpg" ], "indications_and_usage": [ "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs." ], "set_id": "4196cb63-de0e-4c76-b913-3a0bb85203b3", "id": "1c2ca992-c050-4ea6-a849-e5746b3e7eae", "active_ingredient": [ "Active Ingredient Purpose Undecylenic Acid 3%........................Anti-fungal Anti-fungal" ] }, { "effective_time": "20130819", "purpose": [ "Purpose Antihistamine" ], "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. (1-800-222-1222)" ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-800-343-7805" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) do not use if blister unit is open or torn see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "4694a68d-238f-4609-a043-ef12c2f58fa8", "id": "91cb23d6-4c1b-4d7e-b3b6-2a01e4229564", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each chewable tablet) Cetirizine HCl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, betacyclodextrin, calcium silicate, carmine, colloidial silicon dioxide, disodium inosinate/guanylate, ethyl acetate, FD&C blue no. 2 aluminum lake, flavors, lactose monohydrate, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified cornstarch, sorbitol" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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. (1-800-222-1222)" ], "spl_product_data_elements": [ "Childrens Zyrtec Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine calcium silicate silicon dioxide ethyl acetate FD&C blue no. 2 aluminum oxide lactose monohydrate magnesium stearate maltodextrin mannitol cellulose, microcrystalline starch, corn sorbitol Round purple, bilayer tablet Zyrtec;C5" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions may be taken with or without water adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Original Prescription Strength NDC 50580-720-13 Children's ZYRTEC ® ALLERGY Cetirizine HCl/ antihistamine 5 mg chewable tablets Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 6 yrs. & older 5 mg each Grape Chewables 5 Chewable Tablets 5 mg each Principal Display Panel" ] }, { "effective_time": "20141219", "inactive_ingredient": [ "Inactive Ingredients amyl acetate, benzalkonium chloride, castor oil, clove bud oil, ethyl alcohol, isobutane-propane (propellant), n-Butyl acetate, nitrocellulose", "Inactive Ingredients amyl acetate, benzalkonium chloride, castor oil, clove bud oil, ethyl alcohol, n-Butyl acetate, nitrocellulose", "Inactive Ingredients amyl acetate, camphor, ethyl acetate, ethyl alcohol, n-butyl acetate, nitrocellulose" ], "purpose": [ "Purpose First Aid Antiseptic", "Purpose First Aid Antiseptic", "Purpose Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings For external use only. Flammable. Keep away from fire or flame. Do not use in the eyes excessive amounts over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Stop use and ask a doctor if condition persists or gets worse infection occurs When using this product do not puncture or incinerate; contents under pressure do not store at temperatures above 120ºF intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.", "Warnings For external use only. Flammable. Keep away from fire or flame. Do not use in the eyes or apply over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Stop use and ask a doctor if condition persists or gets worse infection occurs When using this product do not store at temperatures above 120ºF intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.", "Warnings For external use only. Flammable. Keep away from fire or flame. Do not use in the eyes over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes When using this product do not puncture or incinerate; contents under pressure do not store at temperatures above 120ºF intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal Stop use and ask a doctor if condition persists or gets worse infection occurs Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center (1-800-222-1222) right away." ], "when_using": [ "When using this product do not puncture or incinerate; contents under pressure do not store at temperatures above 120ºF intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal", "When using this product do not store at temperatures above 120ºF intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal", "When using this product do not puncture or incinerate; contents under pressure do not store at temperatures above 120ºF intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal" ], "questions": [ "Questions? 1-800-443-4908 www.newskinproducts.com Drug Facts", "Questions? 1-800-443-4908 www.newskinproducts.com Drug Facts", "Questions? 1-800-443-4908 www.newskinproducts.com" ], "spl_product_data_elements": [ "New Skin Bandage Benzethonium Chloride BENZETHONIUM CHLORIDE BENZETHONIUM AMYL ACETATE CAMPHOR (SYNTHETIC) ETHYL ACETATE ALCOHOL BUTYL ACETATE PYROXYLIN New Skin Bandage Benzethonium Chloride BENZETHONIUM CHLORIDE BENZETHONIUM AMYL ACETATE BENZALKONIUM CHLORIDE CASTOR OIL CLOVE OIL ALCOHOL BUTYL ACETATE New Skin Bandage Benzethonium Chloride BENZETHONIUM CHLORIDE BENZETHONIUM AMYL ACETATE BENZALKONIUM CHLORIDE CASTOR OIL CLOVE OIL ALCOHOL BUTYL ACETATE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions clean affected area spray a small amount on the area 1-3 times a day let dry a second coating may be applied for extra protection to remove, apply more New-Skin ® Liquid Spray Bandage and quickly wipe off", "Directions clean affected area apply small amount on the area 1-3 times a day let dry a second coating may be applied for extra protection to remove, apply more New-Skin ® Liquid Spray Bandage and quickly wipe off", "Directions clean affected area apply small amount on the area 1-3 times daily let dry a second coating may be applied for extra protection to remove, apply more New-Skin ® Liquid Bandage and quickly wipe off" ], "spl_unclassified_section": [ "Drug Facts", "Other Information store at room temperature away from heat may temporarily sting upon application do not allow to come into contact with floors, countertops or other finished surfaces – will stain if valve doesn’t spray, simply scratch across spray hole with fingernail. New-Skin ® Liquid Spray Bandage may at times form a thin covering over the spray hole.", "Other Information store at room temperature away from heat may temporarily sting upon application do not allow to come into contact with floors, countertops or other finished surfaces – will stain", "Other Information store at room temperature away from heat may temporarily sting upon application do not allow to come into contact with floors, countertops or other finished surfaces – will stain" ], "stop_use": [ "Stop use and ask a doctor if condition persists or gets worse infection occurs", "Stop use and ask a doctor if condition persists or gets worse infection occurs", "Stop use and ask a doctor if condition persists or gets worse infection occurs" ], "do_not_use": [ "Do not use in the eyes excessive amounts over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.", "Do not use in the eyes or apply over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.", "Do not use in the eyes over large areas of the body longer than one week unless directed by a doctor on infected areas or wounds that are draining with other first aid products such as lotions and creams over sutures on mucous membranes" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL America’s #1 Liquid Bandage new-skin® LIQUID SPRAY BANDAGE FIRST AID ANTISEPTIC LIQUID SPRAY BANDAGE OVER 40 APPLICATIONS NET WT 1 OZ (28.5g) PRINCIPAL DISPLAY PANEL new-skin® LIQUID SPRAY BANDAGE FIRST AID ANTISEPTIC LIQUID SPRAY BANDAGE NET WT 1 OZ (28.5g)", "PRINCIPAL DISPLAY PANEL America’s #1 Liquid Bandage new-skin® LIQUID BANDAGE FIRST AID ANTISEPTIC LIQUID BANDAGE LIQUID BANDAGE OVER 100 APPLICATIONS 1.0 FL OZ (30 mL) PRINCIPAL DISPLAY PANEL new-skin® LIQUID BANDAGE 1.0 FL OZ (30 mL)", "PRINCIPAL DISPLAY PANEL America’s #1 Liquid Bandage Waterproof new-skin® LIQUID BANDAGE FIRST AID ANTISEPTIC LIQUID BANDAGE OVER 50 APPLICATIONS 0.3FL OZ (10 mL) America’s #1 Liquid Bandage Waterproof new-skin® LIQUID BANDAGE FIRST AID ANTISEPTIC LIQUID BANDAGE OVER 50 APPLICATIONS 0.3FL OZ (10 mL)" ], "indications_and_usage": [ "Use First aid to help prevent bacterial contamination in minor cuts and scrapes", "Use First aid to help prevent bacterial contamination in minor cuts and scrapes", "Use First aid to help prevent bacterial contamination in minor cuts and scrapes" ], "set_id": "4b98dbf2-ad03-4b98-a098-bedaa786ac57", "id": "01846542-dbbf-423a-b956-0af7d29b16e9", "active_ingredient": [ "Active ingredient Benzethonium Chloride 0.2%", "Active ingredient Benzethonium Chloride 0.2%", "Active ingredient Benzethonium Chloride 0.2%" ] }, { "effective_time": "20130919", "inactive_ingredient": [ "Inactive ingredients Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491", "May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "purpose": [ "Anti-fungal" ], "keep_out_of_reach_of_children": [ "Do not use on children under 2 years of age unless directed by a doctor. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes. Inactive ingredients Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Fiore Rx Coral Sorbet Antifungal Nail Polish Undecylenic Acid Undecylenic Acid Undecylenic Acid Butyl Acetate Ethyl Acetate Pyroxylin POLYESTER-10 Acetyltributyl Citrate Isopropyl Alcohol BENTOQUATAM DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER TITANIUM DIOXIDE Polacrilin D&C RED NO. 6 Silicon Dioxide Benzoresorcinol PROPOLIS WAX Trimethylpentanediyl Dibenzoate" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes." ], "package_label_principal_display_panel": [ "Back panel of bottle" ], "indications_and_usage": [ "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs." ], "set_id": "516e190d-2d88-433e-ac47-8ad6e1bc0c99", "id": "3c3e09f1-2aa8-4bf7-b4dc-8af16d0e3759", "active_ingredient": [ "Active Ingredient Purpose Undecylenic Acid 3%........................Anti-fungal Anti-fungal" ] }, { "effective_time": "20130919", "inactive_ingredient": [ "Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "purpose": [ "Anti-fungal" ], "keep_out_of_reach_of_children": [ "Do not use on children under 2 years of age unless directed by a doctor. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes. Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Fiore Rx Antifungal Nail Lacquer Red Velvet Cake Undecylenic Acid Undecylenic Acid Undecylenic Acid Butyl Acetate Ethyl Acetate Pyroxylin POLYESTER-10 Acetyltributyl Citrate Isopropyl Alcohol DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER Bentoquatam D&C Red No. 7 Butyl Alcohol Silicon Dioxide D&C Red No. 6 Benzoresorcinol PROPOLIS WAX Trimethylpentanediyl Dibenzoate D&C Red No. 34" ], "openfda": {}, "version": "7", "dosage_and_administration": [ "Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes." ], "package_label_principal_display_panel": [ "Fiore Rx Drug Facts Label.jpg" ], "indications_and_usage": [ "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs." ], "set_id": "573091aa-78a0-41e0-a6f2-ac0076e9cc8f", "id": "f73e80ce-e1f9-4833-97f7-695adfb68860", "active_ingredient": [ "Active Ingredient Purpose Undecylenic Acid 3%........................Anti-fungal Anti-fungal" ] }, { "effective_time": "20130919", "inactive_ingredient": [ "Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491", "May contain: Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "purpose": [ "Anti-fungal" ], "keep_out_of_reach_of_children": [ "Do not use on children under 2 years of age unless directed by a doctor. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice." ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Fiore Rx Rock Candy Clear Antifungal Nail Lacquer Undecylenic Acid Undecylenic Acid Undecylenic Acid Butyl Acetate Ethyl Acetate Pyroxylin POLYESTER-10 Acetyltributyl Citrate Isopropyl Alcohol Oxybenzone Trimethylpentanediyl Dibenzoate PROPOLIS WAX D&C Violet No. 2" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions: Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes." ], "package_label_principal_display_panel": [ "drug facts label" ], "indications_and_usage": [ "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs." ], "set_id": "7faf7a1c-6614-43bc-bef7-36b45d41f8a4", "id": "6e3bcae5-e6bf-4455-ae30-8237138a2cc5", "active_ingredient": [ "Active Ingredient Purpose Undecylenic Acid 3%........................Anti-fungal Anti-fungal" ] }, { "effective_time": "20130128", "inactive_ingredient": [ "Inactive ingredients Water, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Potassium Cetyl Phosphate, Styrene/Acrylates Copolymer, Polysilicone-15, Phenoxyethanol, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Benzoate, Squalane, Acrylates/Steareth-20 Methacrylate Copolymer, Acrylates Copolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Ethylhexylglycerin, Tocopheryl Acetate, Polysorbate 60, Ascorbyl Palmitate, Sodium Phytate, Behenyl Alcohol, Glyceryl Stearate, Palmitic Acid, Stearic Acid, Cetyl Alcohol, Lauryl Alcohol, Myristyl Alcohol, Hydrogenated Soybean Oil, Lecithin, Vaccinium Angustifolium (Blueberry) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Ethyl Acetate, Ethyl Butyrate, Isoamyl Butyrate, Metyl Anthranilate, Methlbenzyl Acetate." ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings For external use only. Do not used 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Everyday Face and Body Broad Spectrum Avobenzone, Octinoxate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER ALKYL (C12-15) BENZOATE DIETHYLHEXYL 2,6-NAPHTHALATE POTASSIUM CETYL PHOSPHATE POLYSILICONE-15 PHENOXYETHANOL GLYCERIN SODIUM BENZOATE SQUALANE AMINOMETHYLPROPANOL ALOE VERA LEAF ETHYLHEXYLGLYCERIN ALPHA-TOCOPHEROL ACETATE POLYSORBATE 60 ASCORBYL PALMITATE PHYTATE SODIUM DOCOSANOL GLYCERYL MONOSTEARATE PALMITIC ACID STEARIC ACID CETYL ALCOHOL LAURYL ALCOHOL MYRISTYL ALCOHOL HYDROGENATED SOYBEAN OIL LOWBUSH BLUEBERRY SUNFLOWER SEED ETHYL ACETATE ETHYL BUTYRATE ISOAMYL BUTYRATE METHYL ANTHRANILATE METHYLBENZYL ACETATE" ], "other_safety_information": [ "Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decease 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." ], "openfda": {}, "version": "30751", "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 when exposed to sunlight. Children under 6 months: Ask a doctor." ], "storage_and_handling": [ "Other Protect the product in this container from excessive heat and direct sun." ], "package_label_principal_display_panel": [ "Package Label Principal Display Panel image of tube label image of carton" ], "indications_and_usage": [ "Uses Helps prevent sunburn. I used as directed with other sun protection measures (see Directions), decreases the risk of the skin cancer and early skin aging caused by the sun." ], "set_id": "830e6e65-d889-4abe-8804-54462891c1e0", "id": "527fb391-7956-4d65-ad05-d7cbdcb62004", "active_ingredient": [ "Active ingredients Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 2.8%" ] }, { "effective_time": "20130919", "inactive_ingredient": [ "Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer anhydride, acetyl tributyl citrate, isopropyl alcohol May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491", "May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "purpose": [ "Anti-fungal" ], "keep_out_of_reach_of_children": [ "Do not use on children under 2 years of age unless directed by a doctor. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Directions : Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes. Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer anhydride, acetyl tributyl citrate, isopropyl alcohol May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Fiore Rx Almond Milk Matte Antifungal Nail Lacquer Undecylenic Acid Undecylenic Acid Undecylenic Acid Butyl Acetate Ethyl Acetate Pyroxylin SILICON DIOXIDE ISOPROPYL ALCOHOL POLYESTER-10 Acetyltributyl Citrate BUTYL ALCOHOL Polacrilin PROPOLIS WAX Benzoresorcinol" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions : Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes." ], "package_label_principal_display_panel": [ "Drug facts label" ], "indications_and_usage": [ "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs." ], "set_id": "929e44ec-45d7-42f4-a7e4-ebfe6a2b8435", "id": "c16568f2-cf08-4224-80c3-6ecc10d05215", "active_ingredient": [ "Active Ingredient Purpose Undecylenic Acid 3%........................Anti-fungal Anti-fungal" ] }, { "effective_time": "20120521", "inactive_ingredient": [ "Inactive ingredients Water, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Potassium Cetyl Phosphate, Styrene/Acrylates Copolymer, Polysilicone-15, Phenoxyethanol, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Benzoate, Squalane, Acrylates/Steareth-20 Methacrylate Copolymer, Acrylates Copolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Ethylhexylglycerin, Tocopheryl Acetate, Polysorbate 60, Ascorbyl Palmitate, Sodium Phytate, Behenyl Alcohol, Glyceryl Stearate, Palmitic Acid, Stearic Acid, Cetyl Alcohol, Lauryl Alcohol, Myristyl Alcohol, Hydrogenated Soybean Oil, Lecithin, Vaccinium Angustifolium (Blueberry) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Ethyl Acetate, Ethyl Butyrate, Isoamyl Butyrate, Metyl Anthranilate, Methlbenzyl Acetate." ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings For external use only. Do not used 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions Contact our Sun Specialists for Questions: 877.564.7330" ], "spl_product_data_elements": [ "Everyday Face and Body Broad Spectrum Avobenzone, Octinoxate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER ALKYL (C12-15) BENZOATE DIETHYLHEXYL 2,6-NAPHTHALATE POTASSIUM CETYL PHOSPHATE POLYSILICONE-15 PHENOXYETHANOL GLYCERIN SODIUM BENZOATE SQUALANE AMINOMETHYLPROPANOL ALOE VERA LEAF ETHYLHEXYLGLYCERIN ALPHA-TOCOPHEROL ACETATE POLYSORBATE 60 ASCORBYL PALMITATE PHYTATE SODIUM DOCOSANOL GLYCERYL MONOSTEARATE PALMITIC ACID STEARIC ACID CETYL ALCOHOL LAURYL ALCOHOL MYRISTYL ALCOHOL HYDROGENATED SOYBEAN OIL LOWBUSH BLUEBERRY SUNFLOWER SEED ETHYL ACETATE ETHYL BUTYRATE ISOAMYL BUTYRATE METHYL ANTHRANILATE METHYLBENZYL ACETATE" ], "other_safety_information": [ "Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decease 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." ], "openfda": {}, "version": "30473", "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 when exposed to sunlight. Children under 6 months: Ask a doctor." ], "package_label_principal_display_panel": [ "image of label" ], "indications_and_usage": [ "Uses Helps prevent sunburn. I used as directed with other sun protection measures (see Directions), decreases the risk of the skin cancer and early skin aging caused by the sun." ], "set_id": "9a4ef08a-dc47-43c0-b2d5-df7ebe25725f", "id": "34195655-f2c9-4464-b2ad-34abbe59504b", "active_ingredient": [ "Active ingredients Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 2.8%" ] }, { "effective_time": "20100622", "inactive_ingredient": [ "Inactive ingredients acetone, amyl acetate, castor oil, drometrizole, ethyl acetate, nitrocellulose, SD alcohol 40-B" ], "purpose": [ "Active ingredients Purpose Benzethonium chloride 0.2% First aid antiseptic Dyclonine hydrochloride 0.75% 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 Flammable: Keep away from fire or flame Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Do not use for longer than 1 week unless directed by a doctor. When using this product avoid contact with the eyes. Stop use and ask a doctor if the condition gets worse, 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." ], "when_using": [ "When using this product avoid contact with the eyes." ], "questions": [ "Questions? call 1-800-344-7239" ], "spl_product_data_elements": [ "Skin Shield Benzethonium Chloride and Dyclonine Hydrochloride Benzethonium Chloride Benzethonium Dyclonine Hydrochloride Dyclonine Acetone Amyl Acetate Castor Oil Drometrizole Ethyl Acetate" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: Clean the affected area. Dry thoroughly. Brush a small amount of product on the area 1 to 3 times daily and let dry. Hold knees, elbows, knuckles in bent position during application and drying. For more protection, apply second coat. Children under 2 years of age: Consult a doctor." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Insight Pharmaceuticals Corp. Langhorne, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if the condition gets worse, or if symptoms persist for more than 7 days, or clear up and occur again within a few days." ], "storage_and_handling": [ "Other information To remove: peel off or apply a fresh layer of product over dry product and using gauze, rub off gently while still wet. Cap bottle tightly Store at room temperature 15°-25°C (59°-77°F). Keep carton for full drug facts." ], "do_not_use": [ "Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Do not use for longer than 1 week unless directed by a doctor." ], "active_ingredient_table": [ "
Active ingredients Purpose
Benzethonium chloride 0.2% First aid antiseptic
Dyclonine hydrochloride 0.75% Topical analgesic
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 26.6 ml Bottle Carton ECONOMY SIZE Skin Shield ® Liquid Bandage First Aid Antiseptic Pain Reliever NET WT. 0.9 fl oz (26.6 ml) PRINCIPAL DISPLAY PANEL - 26.6 ml Bottle Carton" ], "indications_and_usage": [ "Uses first aid for the temporary relief of pain and to help protect against infection in minor cuts, scrapes and burns." ], "set_id": "bc596cfe-1229-42c1-940b-c40a81ead64f", "id": "6265bf84-0828-494b-b781-55351012e3e4", "purpose_table": [ "
Active ingredients Purpose
Benzethonium chloride 0.2% First aid antiseptic
Dyclonine hydrochloride 0.75% Topical analgesic
" ], "active_ingredient": [ "Active ingredients Purpose Benzethonium chloride 0.2% First aid antiseptic Dyclonine hydrochloride 0.75% Topical analgesic" ] }, { "effective_time": "20130919", "inactive_ingredient": [ "Inactive ingredients Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491", "May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "purpose": [ "Anti-fungal" ], "keep_out_of_reach_of_children": [ "Do not use on children under 2 years of age unless directed by a doctor. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes. Inactive ingredients Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Fiore Rx Pixie Dust Pink Antifungal Nail Polish Undecylenic Acid Undecylenic Acid Undecylenic Acid Butyl Acetate Ethyl Acetate Pyroxylin POLYESTER-10 Acetyltributyl Citrate Isopropyl Alcohol DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER Bentoquatam TITANIUM DIOXIDE BUTYL ALCOHOL Silicon Dioxide Benzoresorcinol MICA PROPOLIS WAX Trimethylpentanediyl Dibenzoate D&C RED NO. 34 D&C RED NO. 6 STANNIC OXIDE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes." ], "package_label_principal_display_panel": [ "Back panel of bottle" ], "indications_and_usage": [ "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs." ], "set_id": "c26c84c5-af2f-4587-ab3b-3f405493c991", "id": "e472d4a8-1150-4b38-a370-83f4c0fdf5d5", "active_ingredient": [ "Active Ingredient Purpose Undecylenic Acid 3%........................Anti-fungal Anti-fungal" ] }, { "effective_time": "20130919", "inactive_ingredient": [ "Inactive ingredients Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491", "May contain: Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "purpose": [ "Anti-fungal" ], "keep_out_of_reach_of_children": [ "Do not use on children under 2 years of age unless directed by a doctor. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes. Inactive ingredients Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Fiore Rx Pink Peppermint Pie Antifungal Nail Polish Undecylenic Acid Undecylenic Acid Undecylenic Acid Butyl Acetate Ethyl Acetate Pyroxylin POLYESTER-10 Acetyltributyl Citrate Isopropyl Alcohol BENTOQUATAM DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER TITANIUM DIOXIDE Polacrilin D&C RED NO. 6 Silicon Dioxide Benzoresorcinol PROPOLIS WAX Trimethylpentanediyl Dibenzoate" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes." ], "package_label_principal_display_panel": [ "Back panel of bottle" ], "indications_and_usage": [ "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs." ], "set_id": "c3bdd971-bbd5-4ab1-b59b-924207035fee", "id": "20d83e39-88d8-4aff-8a57-3c5a7eec438f", "active_ingredient": [ "Active Ingredient Purpose Undecylenic Acid 3%........................Anti-fungal Anti-fungal" ] }, { "effective_time": "20120518", "inactive_ingredient": [ "Inactive ingredients Water, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Potassium Cetyl Phosphate, Styrene/Acrylates Copolymer, Polysilicone-15, Phenoxyethanol, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Benzoate, Squalane, Acrylates/Steareth-20 Methacrylate Copolymer, Acrylates Copolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Ethylhexylglycerin, Tocopheryl Acetate, Polysorbate 60, Ascorbyl Palmitate, Sodium Phytate, Behenyl Alcohol, Glyceryl Stearate, Palmitic Acid, Stearic Acid, Cetyl Alcohol, Lauryl Alcohol, Myristyl Alcohol, Hydrogenated Soybean Oil, Lecithin, Vaccinium Angustifolium (Blueberry) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Ethyl Acetate, Ethyl Butyrate, Isoamyl Butyrate, Metyl Anthranilate, Methlbenzyl Acetate." ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings For external use only. Do not used 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions Contact our Sun Specialists for Questions: 877.564.7330" ], "spl_product_data_elements": [ "Everyday Face and Body Broad Spectrum Avobenzone, Octinoxate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OCTOCRYLENE OCTODRINE WATER ALKYL (C12-15) BENZOATE DIETHYLHEXYL 2,6-NAPHTHALATE POTASSIUM CETYL PHOSPHATE STYRENE POLYSILICONE-15 PHENOXYETHANOL GLYCERIN SODIUM BENZOATE SQUALANE AMINOMETHYLPROPANOL ALOE VERA LEAF ETHYLHEXYLGLYCERIN ALPHA-TOCOPHEROL ACETATE POLYSORBATE 60 ASCORBYL PALMITATE PHYTATE SODIUM DOCOSANOL GLYCERYL MONOSTEARATE PALMITIC ACID STEARIC ACID CETYL ALCOHOL LAURYL ALCOHOL MYRISTYL ALCOHOL HYDROGENATED SOYBEAN OIL EGG PHOSPHOLIPIDS LOWBUSH BLUEBERRY SUNFLOWER SEED ETHYL ACETATE ETHYL BUTYRATE ISOAMYL BUTYRATE METHYL ANTHRANILATE METHYLBENZYL ACETATE" ], "other_safety_information": [ "Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decease 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." ], "openfda": {}, "version": "30451", "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 when exposed to sunlight. Children under 6 months: Ask a doctor." ], "package_label_principal_display_panel": [ "Package Label Principal Display Panel image of bottle" ], "indications_and_usage": [ "Uses Helps prevent sunburn. I used as directed with other sun protection measures (see Directions), decreases the risk of the skin cancer and early skin aging caused by the sun." ], "set_id": "ea69e562-e302-468a-91fc-75d89a29e802", "id": "dbdab024-d7be-45b5-ad1e-e2e36efc4e1c", "active_ingredient": [ "Active ingredients Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 2.8%" ] }, { "effective_time": "20130919", "inactive_ingredient": [ "Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer anhydride, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491", "May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "purpose": [ "Anti-fungal" ], "keep_out_of_reach_of_children": [ "Do not use on children under 2 years of age unless directed by a doctor. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Directions : Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes. Inactive ingredients: Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic copolymer anhydride, acetyl tributyl citrate, isopropyl alcohol, propolis wax May contain: CI 60725, Benzophenone-3, Bensophenone-1, Acrylates Copolymer, Stearalkonium Bentonite, CI 15880, CI 15850, Silica, N-Butyl Alcohol, CI 15850:1, CI 77891, Trimethylpentanediyl Dibenzoate, Styrene Acrylates Copolymer,Mica, Tin Oxide, CI 77510, CI 19140, CI 77491" ], "warnings": [ "Warnings For external use only." ], "spl_product_data_elements": [ "Fiore Rx Eggplant My Garden Antifungal Nail Polish Undecylenic Acid Undecylenic Acid Undecylenic Acid Butyl Acetate Ethyl Acetate Pyroxylin POLYESTER-10 ACETYLTRIBUTYL CITRATE ISOPROPYL ALCOHOL BENTOQUATAM DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER Polacrilin D&C RED NO. 34 TITANIUM DIOXIDE FERRIC AMMONIUM FERROCYANIDE SILICON DIOXIDE Benzoresorcinol PROPOLIS WAX TRIMETHYLPENTANEDIYL DIBENZOATE FD&C YELLOW NO. 5 D&C RED NO. 6" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions : Clean nails and dry thoroughly. Remove any nail polish with nail polish remover. Allow to dry thoroughly. Roll your bottle of Fioré Rx Antifungal Nail Lacquer in between your hands to mix the lacquer thoroughly. Do not shake the bottle, as this can introduce air bubbles that will affect the quality of the lacquer. Using only the brush provided in the Fioré Rx bottle, apply a strip of lacquer down the middle of your nail from cuticle to tip before following it with lacquer on either side. Allow lacquer to dry for at least 2 minutes. For best results, apply a second coat and allow to dry for 30 minutes." ], "package_label_principal_display_panel": [ "Drug facts label" ], "indications_and_usage": [ "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs." ], "set_id": "fe0bdaa8-66b1-45c9-8336-ebcc695eaa8d", "id": "d8465c59-fa95-4c05-96db-a2eae66dc39c", "active_ingredient": [ "Active Ingredient Purpose Undecylenic Acid 3%........................Anti-fungal Anti-fungal" ] } ] }