{ "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": "2026-03-05", "results": { "skip": 0, "limit": 100, "total": 25 } }, "results": [ { "effective_time": "20110701", "inactive_ingredient": [ "Inactive Ingredients petrolatum, lanolin, cod liver oil (contains vitamin A and vitamin D), purified water, talcum, methylparaben, fragrance, butylated hydroxyanisole" ], "purpose": [ "Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness" ], "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. 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 the reach of children. If swallowed get medical help or contact a Poison Control Center right away" ], "spl_product_data_elements": [ "Walgreen Maximum Strength Diaper Rash ZINC OXIDE ZINC OXIDE ZINC OXIDE PETROLATUM LANOLIN METHYLPARABEN BUTYLATED HYDROXYANISOLE WATER TALC COD LIVER OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions - change wet and soiled diapers promptly - cleanse the diaper area - allow to dry - apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged Other information Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness" ], "set_id": "029b63cc-ca66-447f-9fb2-dacee3cce3e7", "id": "798bc7cd-956d-4936-bb3e-38ce0394308a", "active_ingredient": [ "Active ingredient Purpose Zinc Oxide. 40%.......................................Skin protectant" ] }, { "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": "20090831", "inactive_ingredient": [ "Inactive ingredients butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum" ], "purpose": [ "Use treats vaginal yeast infections" ], "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 vaginal use only" ], "when_using": [ "When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur" ], "spl_product_data_elements": [ "TIOCONAZOLE Ointment 6.5% TIOCONAZOLE TIOCONAZOLE TIOCONAZOLE BUTYLATED HYDROXYANISOLE MAGNESIUM ALUMINUM SILICATE PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to human immunodeficiency virus (HIV) that causes AIDS" ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge" ], "spl_unclassified_section": [ "Other information this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. if you have questions about vaginal yeast infections, consult your doctor store at 20 - 25°C (68 - 77°F) see end flap of carton for lot number and expiration date" ], "do_not_use": [ "Do not use if you have never had a vaginal yeast infection diagnosed by a doctor" ], "indications_and_usage": [ "Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years and over: 1.Open the foil packet just before use and remove purple cap. 2.Insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. children under 12 years of age: ask a doctor", "Do not use if sealed foil packet torn, open, or incompletely sealed. 1-DOSE TREATMENT TIOCONAZOLE OINTMENT 6.5% VAGINAL ANTIFUNGAL DIRECTIONS FOR USE Tear open foil packet just before using. It is best to use at bedtime. Remove applicator and plunger from packet. Applicator is prefilled with vaginal ointment. While firmly holding the purple-capped end of the applicator, push the tip of the plunger into the base of applicator. REMOVE PURPLE CAP from top of applicator with a pull-twist action. Insert the applicator Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go comfortably. Push the plunger into the applicator until it will go no farther. Withdraw the applicator and plunger and dispose of it in the wastebasket. Do not flush. DO NOT USE TAMPONS while using this medicine. Use sanitary napkins instead. PLEASE READ EDUCATIONAL BROCHURE FOR ADDITIONAL INFORMATION. 4260000 P6 DISTRIBUTED BY PERRIGO ALLEGAN, MI 48010 U.S.A. Tioconazole_oint_fig1-01 Tioconazole_oint_fig2-01 Tioconazole_oint_fig3-01" ], "set_id": "11ddf219-8537-4a8f-b267-ef965159885e", "id": "11ddf219-8537-4a8f-b267-ef965159885e", "active_ingredient": [ "Active ingredient ( i n each applicator) Tioconazole 300 mg (6.5%) Purpose vaginal antifungal" ] }, { "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%" ] }, { "spl_product_data_elements": [ "DayTime Nitetime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl Nitetime Acetaminophen, Dextromethorphan hydrobromide, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITAN SORBITOL P30;94A;35A Daytime acetaminophen, dextromethorphan HBr, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BUTYLATED HYDROXYANISOLE BUTYLATED HYDROXYTOLUENE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITAN SORBITOL P19;95A;36A" ], "active_ingredient": [ "Active ingredients for Daytime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg", "Active ingredients for Nitetime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "purpose": [ "Purpose for Daytime Pain reliever/fever reducer Cough suppressant Nasal decongestant", "Purpose for Nighttime Pain reliever/fever reducer Cough suppressant Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves common cold and flu symptoms: sore throat headache minor aches and pains fever cough due to minor throat and bronchial irritation nasal congestion (Daytime only) runny nose and sneezing (Nitetime only)" ], "warnings": [ "Warnings Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to make a child sleep (Nitetime only) with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nitetime only) chronic bronchitis glaucoma (Nitetime only) diabetes (Daytime only) heart disease (Daytime only) thyroid disease (Daytime only) high blood pressure (Daytime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nitetime only) When using this product, do not use more than directed. In addition, when using Nitetime: excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur (Daytime only) pain, cough, and (for Daytime only) nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose can cause liver damage. 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." ], "do_not_use": [ "Do not use to make a child sleep (Nitetime only) with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nitetime only) chronic bronchitis glaucoma (Nitetime only) diabetes (Daytime only) heart disease (Daytime only) thyroid disease (Daytime only) high blood pressure (Daytime only)" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nitetime only)" ], "when_using": [ "When using this product, do not use more than directed. In addition, when using Nitetime: excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur (Daytime only) pain, cough, and (for Daytime only) nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "pregnancy_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. Overdose warning : Taking more than the recommended dose can cause liver damage. 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." ], "dosage_and_administration": [ "Directions do not take more than directed (see Overdose warning ) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve Daytime : adults and children 12 years and over: take 2 softgels with water every 4 hours Nitetime : adults and children 12 years and over: take 2 softgels with water every 6 hours children under 12 years: do not use" ], "storage_and_handling": [ "Other information store at room temperature 15°-30°C (59°-86°F) avoid excessive heat" ], "inactive_ingredient": [ "Inactive ingredients Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol *may contain this ingredient Nitetime D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan sorbitol" ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the Active Ingredients in Vicks® DayQuil® and NyQuil® LiquiCaps®† NON-DROWSY DAYTIME / MULTI-SYMPTOM NITETIME COLD/FLU RELIEF LIQUID CAPS Acetaminophen - Pain Reliever-Fever Reducer / Acetaminophen - Pain Reliever-Fever Reducer Dextromethorphan HBr - Cough Suppressant / Dextromethorphan HBr - Cough Suppressant Phenylephrine HCl - Nasal Decongestant / Doxylamine Succinate - Antihistamine DAYTIME SOFTGELS / NITETIME SOFTGELS Alcohol Free Antihistamine Free When using Daytime and Nitetime products, carefully read the labeling to insure correct dosing KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. DISTRIBUTED BY FOODHOLD U.S.A., LLC LANDOVER, MD 20785 †This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® LiquiCaps®.", "Product Label Care One Daytime / Nitetime Cold Flu Relief Acetaminophen 325 mg, Dextromethorphan HBr 10 mg; Phenylephrine HCl 5 mg; Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine succinate 6.25 mg" ], "set_id": "196d8d95-a2db-4695-b3b5-daced8417f5b", "id": "985662a0-7a67-4031-8538-3f7d9d4f4dae", "effective_time": "20130620", "version": "4", "openfda": {} }, { "effective_time": "20110110", "inactive_ingredient": [ "Inactive ingredients butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water Manufactured by: Banner Pharmacaps Inc. 4125 Premier Drive High Point, NC 27265" ], "purpose": [ "Purpose Anti-diarrheal" ], "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 Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl" ], "when_using": [ "When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery." ], "spl_product_data_elements": [ "LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE BUTYLATED HYDROXYANISOLE FD&C BLUE NO. 1 GELATIN GLYCERIN GLYCERYL CAPRYLATE POLYOXYL 40 HYDROGENATED CASTOR OIL WATER" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool a history of liver disease" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information do not use if carton or blister unit is open or torn store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F). see side panel for lot number and expiration date use the 1 mg soft gelatin capsule product for children 6 to under 12 years of age" ], "stop_use": [ "Stop use and ask doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. side effects occur. You may want to report side effects to FDA at 1800-FDA-1088." ], "do_not_use": [ "Do not use if you have bloody or black stool in children under 12 years of age (see Other information )" ], "package_label_principal_display_panel": [ "Principal Display Panel-Shipping Label NDC 10888-7098-1 Loperamide HCl, 2 mg (Liquid Filled Capsules) 20,000 Softgels IMPORTANT This bulk shipment, is intended for further processing only. It is not to be used in its present condition, and it should be re-packaged immediately, and labeled strictly in conformance with the FD&C Act and regulations. Store below 60% relative humidity at 59°-86°F (15°-30°C)-do not refrigerate. CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING ONLY. BANNER PHARMACAPS Inc BULK LABEL 2 mg" ], "indications_and_usage": [ "Use controls symptoms of diarrhea, including Travelers'Diarrhea" ], "set_id": "2893b150-7ce0-49b3-b003-b31d9634a339", "id": "99503bc7-bec1-45bd-8498-403bd38d9882", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking antibiotics" ], "active_ingredient": [ "Active ingredient(in each capsule) Loperamide HCI 2 mg" ] }, { "effective_time": "20101208", "inactive_ingredient": [ "Inactive ingredients beeswax, benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, purified water, thyme oil, tocopherol" ], "purpose": [ "Purpose Protectant Vasoconstrictor Protectant 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 and/or intrarectal use only." ], "when_using": [ "When using this product do not exceed the recommended daily dosage unless directed by a doctor." ], "spl_product_data_elements": [ "Hemorrhoidal mineral oil and phenylephrine hcl and shark liver oil and white petrolatum MINERAL OIL MINERAL OIL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SHARK LIVER OIL SHARK LIVER OIL PETROLATUM PETROLATUM YELLOW WAX BENZOIC ACID BUTYLATED HYDROXYANISOLE CORN OIL GLYCERIN LANOLIN LANOLIN ALCOHOLS METHYLPARABEN PARAFFIN PROPYLPARABEN WATER THYME OIL ALPHA-TOCOPHEROL" ], "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" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 12 years and older: 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 a soft cloth before applying ointment when first opening the tube, unscrew the cap, use pointed end on cap to puncture seal apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement INTRARECTAL USE remove cover from applicator attach applicator to tube lubricate applicator well and gently insert applicator into the rectum thoroughly cleanse 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 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 bleeding occurs condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain" ], "spl_unclassified_section": [ "Other information store at 15° to 30°C (59° to 86°F) for lot number and expiration date, see crimp of tube or see 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. 1/10 R4 8265485 0520" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the carton for Hemorrhoidal Ointment." ], "indications_and_usage": [ "Uses helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue and relieves burning 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": "2b07633a-5c45-4983-8034-70e0fdf933b8", "id": "e98ee1a8-c241-4df4-95ce-9916f7959d4f", "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 Mineral oil, USP 14% Phenylephrine HCl, USP 0.25% Shark liver oil 3.0% White Petrolatum, USP 71.9%" ] }, { "effective_time": "20101215", "inactive_ingredient": [ "Inactive Ingredients aloe barbadensis leaf juice, butylated hydroxyanisole, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate SE, laureth-23, methylparaben, mineral oil, penthenol, propylene glycol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, tocopheryl acetate, xanthan gum" ], "purpose": [ "Active ingredients Purpose Glycerin 14.4%.................................................Protectant Petrolatum 15.0%.............................................Protectant Phenylephrine Hydrochloride.............................Vasoconstrictor Pramoxine Hydrochloride..................................Local anesthetic Use s - for temporary relief of 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" ], "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. Ask a doctor before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged 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 - do not put into rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if - bleeding occurs - 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 breast feeding, ask a health professional before use. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away" ], "spl_product_data_elements": [ "CVS Hemorrhoidal PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER CETYL ALCOHOL GLYCERYL MONOSTEARATE CARBOXYMETHYLCELLULOSE SODIUM LAURETH-23 MINERAL OIL PANTHENOL GLYCERIN GLYCERIN PETROLATUM PETROLATUM PROPYL GALLATE STEARYL ALCOHOL PROPYLENE GLYCOL SODIUM BENZOATE STEARETH-2 STEARETH-20 .ALPHA.-TOCOPHEROL ACETATE, D- XANTHAN GUM ALOE VERA LEAF BUTYLATED HYDROXYANISOLE EDETATE DISODIUM CITRIC ACID MONOHYDRATE METHYLPARABEN PROPYLPARABEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "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 dispensing cap well, then gently insert cap partway into the anus. - thoroughly cleanse dispensing cap after each use and replace cover - children under 12 years of age: ask a doctor" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Use s - for temporary relief of 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 Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)" ], "set_id": "37b1e849-3079-4f8e-b712-9520a1e0dd89", "id": "781a477f-015c-47a0-9706-162cd1b60e82", "active_ingredient": [ "Active ingredients Purpose Glycerin 14.4%.................................................Protectant Petrolatum 15.0%.............................................Protectant Phenylephrine Hydrochloride.............................Vasoconstrictor Pramoxine Hydrochloride..................................Local anesthetic" ] }, { "effective_time": "20110919", "inactive_ingredient": [ "Inactive ingredients purified water USP, isopropyl myristate NF, stearyl alcohol NF, glyceryl stearate and sodium lauryl sulfate NF, propylene glycol USP, ozokerite, poloxamer 188, steareth-20, ceteareth-3, fragrance, dimethicone, sodium metabisulfite NF, methylparaben NF, propylparaben NF, sodium lauryl sulfate NF, butylated hydroxyanisole NF, anhydrous citric acid USP, edetate disodium" ], "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." ], "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." ], "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 Daytime with Moisturizers and Sunscreen hydroquinone, oxybenzone, and padimate o hydroquinone hydroquinone oxybenzone oxybenzone padimate o padimate o water isopropyl myristate stearyl alcohol glyceryl monostearate sodium lauryl sulfate propylene glycol ceresin poloxamer 188 steareth-20 dimethicone sodium metabisulfite methylparaben propylparaben butylated hydroxyanisole anhydrous citric acid edetate disodium" ], "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", "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.", "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 - 70 g Jar Carton Skin Lightener with Moisturizers and Sunscreen NDC # 99207-291-02 E ESOTÉRICA ® ESOTÉRICA ® FADE CREAM DAYTIME With Moisturizers and Sunscreen 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. Contains a sunscreen to help prevent darkening from reoccurring." ], "set_id": "38edad42-4c0d-43eb-b541-a10009e6cf55", "id": "e67fac0a-52f2-4403-914d-53ea6f02e155", "purpose_table": [ "
Active ingredients: Purpose:
Hydroquinone USP 2% Skin Lightener
Oxybenzone USP 2.5% Sunscreen
Padimate O USP 3.3% Sunscreen
" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid" ], "active_ingredient": [ "Active ingredients: Purpose: Hydroquinone USP 2% Skin Lightener Oxybenzone USP 2.5% Sunscreen Padimate O USP 3.3% Sunscreen" ] }, { "effective_time": "20120702", "inactive_ingredient": [ "Inactive ingredients butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum" ], "purpose": [ "Purpose Vaginal antifungal" ], "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 vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to human immunodeficiency virus (HIV) that causes AIDS When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, 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." ], "when_using": [ "When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur" ], "questions": [ "Questions? call toll-free 877-666-4782 or 215-273-8755 (collect)" ], "spl_product_data_elements": [ "Tioconazole 1 Day Tioconazole Tioconazole Tioconazole butylated hydroxyanisole magnesium aluminum silicate petrolatum" ], "ask_doctor": [ "Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to human immunodeficiency virus (HIV) that causes AIDS" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years and over: open the foil packet just before use and remove purple cap insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. children under 12 years of age: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: INSIGHT Pharmaceuticals, LLC. Langhorne, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge" ], "storage_and_handling": [ "Other information this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. if you have questions about vaginal yeast infections, consult your doctor store at 20° - 25°C (68° - 77°F) see end flap of carton for lot number and expiration date" ], "do_not_use": [ "For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 4.6g Applicator Carton 1 DAY TREATMENT • PREFILLED APPLICATOR 1-DAY Tioconazole Ointment 6.5% VAGINAL ANTIFUNGAL CURES MOST VAGINAL YEAST INFECTIONS CLINICALLY PROVEN 1 DAY TREATMENT Net Wt. 4.6g (0.16oz) filled applicator PRINCIPAL DISPLAY PANEL - 4.6g Applicator Carton" ], "indications_and_usage": [ "Use treats vaginal yeast infections" ], "set_id": "41258b67-6ce7-48f1-9787-6824902cb203", "id": "561d72af-1eae-4009-8576-afc274365166", "active_ingredient": [ "Active ingredient (in each applicator) Tioconazole 300 mg (6.5%)" ] }, { "effective_time": "20121002", "inactive_ingredient": [ "Inactive ingredients benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water" ], "purpose": [ "Purpose Antifungal" ], "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 avoid contact with the eyes" ], "spl_product_data_elements": [ "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 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 supervise children in the use of this product For athlete's foot: use daily for 4 weeks. If condition persists longer, consult a doctor. pay special attention to the spaces between the toes wear well-fitting, ventilated shoes change shoes and socks at least once daily For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails." ], "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 see box to open: unscrew cap, use pointed end on cap to puncture seal You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811 .", "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 10/09 R2 8280719 7805 Repackaged by Rebel Distributors Corp. Thousand Oaks, CA 91320" ], "stop_use": [ "Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) irritation occurs or if there is no improvement within 2 weeks (for jock itch)" ], "do_not_use": [ "Do not use on children under 2 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Miconazole Nitrate 2%" ], "indications_and_usage": [ "Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, scaling, cracking, burning and discomfort associated with those conditions" ], "set_id": "74a80da6-0279-4946-b7ee-d3e43330ba2c", "id": "74a80da6-0279-4946-b7ee-d3e43330ba2c", "active_ingredient": [ "Active ingredient Miconazole nitrate 2%" ] }, { "effective_time": "20150616", "inactive_ingredient": [ "Inactive ingredients benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water" ], "purpose": [ "Purpose Antifungal" ], "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 avoid contact with the eyes" ], "spl_product_data_elements": [ "Miconazole Nitrate miconazole nitrate MICONAZOLE NITRATE MICONAZOLE BENZOIC ACID BUTYLATED HYDROXYANISOLE MINERAL OIL PEG-5 OLEATE PEGOXOL 7 STEARATE WATER" ], "openfda": {}, "version": "3", "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 supervise children in the use of this product For athlete's foot: use daily for 4 weeks. If condition persists longer, consult a doctor. pay special attention to the spaces between the toes wear well-fitting, ventilated shoes change shoes and socks at least once daily For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails." ], "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 see box to open: unscrew cap, use pointed end on cap to puncture seal 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 R3 8280719 7805" ], "stop_use": [ "Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) irritation occurs or if there is no improvement within 2 weeks (for jock itch)" ], "do_not_use": [ "Do not use on children under 2 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is the carton for Miconazole Nitrate 2% Cream." ], "indications_and_usage": [ "Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, scaling, cracking, burning and discomfort associated with those conditions" ], "set_id": "820c5cf8-494b-4598-bc76-3d03c0a68d76", "id": "d8394d62-eb73-4e2b-8804-279420e94a02", "active_ingredient": [ "Active ingredient Miconazole nitrate 2%" ] }, { "effective_time": "20131021", "inactive_ingredient": [ "Inactive Ingredients benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, mineral oil, paraffin, propylparaben, shark liver oil, thyme oil, tocopherol acetate, yellow wax, purified water." ], "purpose": [ "Purpose Protectant Protectant Vasoconstrictor" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested seek medical attention immediately or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only" ], "spl_product_data_elements": [ "Budpak Hemorrhoid Anesthetic Mineral Oil, Petrolatum, Phenylephrine HCL MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID BUTYLATED HYDROXYANISOLE CORN OIL GLYCERIN LANOLIN LANOLIN ALCOHOLS METHYLPARABEN PARAFFIN PROPYLPARABEN SHARK LIVER OIL THYME OIL .ALPHA.-TOCOPHEROL ACETATE YELLOW WAX WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Cleanse the affected area with mild soap and warm water, rinse thoroughly. Dry by patting or blotting with toilet tissue or soft cloth before applying this product. Cover the entire affected area with a thin layer 1 to 3 times daily. Children under 12 years of age need to consult a doctor before using this product." ], "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. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. If you are pregnant, do not use this product without first consulting a doctor." ], "spl_unclassified_section": [ "Other Information Store at room temperature 20ºC to 25ºC (68ºF to 77ºF) Lot No. & Exp. Date: see crimp of tube.", "PRINCIPAL DISPLAY PANEL Budpak Hemorrhoid Anesthetic Ointment Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCL 0.25% NET WT 1 OZ (28 g)" ], "package_label_principal_display_panel": [ "image of package label" ], "indications_and_usage": [ "Uses For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles." ], "set_id": "8cb751f8-9a7d-4f2b-94b8-7f40ab2c23a6", "id": "16ef05c6-c8e0-4de4-b4d3-43d408a0fd7b", "active_ingredient": [ "Active Ingredients Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCL 0.25%" ] }, { "effective_time": "20110811", "purpose": [ "Active ingredients (in each capsule) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Chlorpheniramine maleate 2 mg Antihistamine Dextromethorphan hydrobromide 10 mg Cough suppressant Phenylephrine hydrochloride 5 mg Nasal decongestant" ], "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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST) or www.alkaseltzerplus.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at room temperature. Avoid excessive heat." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache nasal and sinus congestion cough runny nose sneezing sore throat temporarily reduces fever" ], "set_id": "8e616ea0-e374-460d-84f2-3812c89742ab", "id": "86fcfecb-547b-4fa6-9ab2-e459fd8572c0", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each capsule) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Chlorpheniramine maleate 2 mg Antihistamine Dextromethorphan hydrobromide 10 mg Cough suppressant Phenylephrine hydrochloride 5 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients butylated hydroxyanisole, butylated hydroxytoluene, D&C red #33, FD&C blue #1, gelatin, glycerin, hypromellose, mannitol, polyethylene glycol 400, polyethylene glycol 600, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 capsules 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 Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to sedate children. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Alka-Seltzer Plus Cold and Cough Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Dextromethorphan hydrobromide Dextromethorphan Chlorpheniramine maleate Chlorpheniramine Phenylephrine hydrochloride Phenylephrine butylated hydroxyanisole butylated hydroxytoluene D&C red No. 33 FD&C blue No. 1 gelatin glycerin hypromelloses mannitol polyethylene glycol 400 polyethylene glycol 600 povidone K30 propylene glycol water sorbitan sorbitol titanium dioxide" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than the recommended dose adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 12 capsules in 24 hours or as directed by a doctor. children under 12 years: do not use" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Bayer HealthCare LLC Consumer Care P.O. Box 1910 Morristown, NJ 07962-1910 USA" ], "stop_use": [ "Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs" ], "do_not_use": [ "Do not use to sedate children. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age" ], "active_ingredient_table": [ "
Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg Antihistamine
Dextromethorphan hydrobromide 10 mg Cough suppressant
Phenylephrine hydrochloride 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 40 Capsule Carton Alka-Seltzer Plus ® COLD & COUGH FORMULA Cough Nasal Congestion Runny Nose Headache + Body Ache Sinus Pressure Acetaminophen / Pain reliever-fever reducer Chlorpheniramine maleate / Antihistamine Dextromethorphan hydrobromide / Cough suppressant Phenylephrine HCl / Nasal decongestant 40 LIQUID GELS (Liquid Filled Capsules) Principal Display Panel - 40 Capsule Carton" ], "purpose_table": [ "
Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg Antihistamine
Dextromethorphan hydrobromide 10 mg Cough suppressant
Phenylephrine hydrochloride 5 mg Nasal decongestant
" ] }, { "effective_time": "20140403", "inactive_ingredient": [ "Inactive ingredients benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopheryl acetate, white wax Questions or comments? 1-800-719-9260" ], "purpose": [ "Purposes Protectant Vasoconstrictor" ], "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 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 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 • condition worsens or does not improve within 7 days • introduction of applicator into the rectum causes additional pain If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product do not exceed the recommended daily dosage unless directed by a doctor" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "smart sense hemorrhoidal mineral oil, petrolatum, phenylephrine HCl MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID BUTYLATED HYDROXYANISOLE CORN OIL GLYCERIN LANOLIN LANOLIN ALCOHOLS METHYLPARABEN PARAFFIN PROPYLPARABEN WATER THYME OIL .ALPHA.-TOCOPHEROL ACETATE WHITE WAX light" ], "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" ], "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 a soft cloth before applying ointment. • when first opening the tube, puncture foil seal with top end of cap • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse 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 years of age: ask a doctor Other information • store at 20-25°C (68-77°F)" ], "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 worsens or does not improve within 7 days • introduction of applicator into the rectum causes additional pain" ], "storage_and_handling": [ "Other information • store at 20-25°C (68-77°F)" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Compare to the active ingredients of Preparation H® Hemorrhoidal Ointment HEMORRHOIDAL Ointment Prevents Further Irritation Prompt, Soothing Relief from Painful Burning, Itching & Discomfort – Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue – Relieves Internal & External Discomfort NET WT 2 OZ (57 g) Smart Sense Hemorrhoidal Ointment Image" ], "indications_and_usage": [ "Uses • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoidal tissue and relieves burning • 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": "8fd4082a-9cf3-44aa-9b26-32726e7c4629", "id": "8fd4082a-9cf3-44aa-9b26-32726e7c4629", "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 Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%" ] }, { "effective_time": "20130130", "inactive_ingredient": [ "Inactive ingredients alcohol, butylated hydroxyanisole, butylparaben, caramel color, flavors, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, potassium citrate, propylparaben, purified water, simethicone emulsion, sorbitol solution" ], "purpose": [ "Purposes Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product constipation may occur. Stop use and ask a doctor if symptoms last more than 2 weeks. Keep out of reach of children." ], "when_using": [ "When using this product constipation may occur." ], "questions": [ "Questions or comments? 1-800-469-5268 (toll-free) or 215-273-8755 (collect)" ], "spl_product_data_elements": [ "ALTERNAGEL Aluminum Hydroxide Aluminum Hydroxide Aluminum Hydroxide alcohol butylated hydroxyanisole butylparaben hypromelloses cellulose, microcrystalline carboxymethylcellulose sodium potassium citrate propylparaben water sorbitol" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake well take 1-2 teaspoons between meals, at bedtime, or as directed by a doctor do not take more than 3 teaspoonfuls in a 24-hour period, or use the maximum dosage for more than 2 weeks" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if symptoms last more than 2 weeks." ], "storage_and_handling": [ "Other information each teaspoon contains: potassium 10 mg, sodium 1 mg do not use if break away band on plastic cap is broken or missing store between 20-25°C (68-77°F) do not freeze" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image not available Principal Display Panel" ], "indications_and_usage": [ "Use relieves: heartburn acid indigestion sour stomach upset stomach due to these symptoms overindulgence in food and drink" ], "set_id": "9714c3d5-56ef-4807-b07a-fef3d0c2f318", "id": "3ed129f9-a550-4d30-af0e-565323c40cb8", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active Ingredients (in each 5 mL teaspoon) Aluminum hydroxide (equivalent to dried gel, USP) 600 mg" ] }, { "effective_time": "20130625", "inactive_ingredient": [ "Inactive ingredients butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol *may contain this ingredient" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning : Taking more than the recommended dose can cause liver damage. 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." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage. Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days new symptoms occur nervousness, dizziness or sleeplessness occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose can cause liver damage. 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." ], "when_using": [ "When using this product, do not exceed recommended dosage." ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "spl_product_data_elements": [ "Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BUTYLATED HYDROXYANISOLE BUTYLATED HYDROXYTOLUENE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITAN SORBITOL P19;95A;36A" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "other_safety_information": [ "Other information store at room temperature15º-30ºC (59º-86ºF) avoid excessive heat" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not take more than directed (see Overdose warning ) do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days new symptoms occur nervousness, dizziness or sleeplessness occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel COMPARE TO THE ACTIVE INGREDIENTS OF VICKS® DAYQUIL® LIQUICAPS®** Non-Drowsy Daytime Multi-Symptom Cold & Flu Relief Acetaminophen , Dextromethorphan HBr, Phenylephrine HCl For Relief of: Aches, Fever, Sore Throat, Cough, Nasal Congestion LIQUID-FILLED SOFTGELS DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC. 10401 MONROE RD., MATTHEWS, NC 28105 USA **This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® LiquiCaps®. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.", "Product Label Family Wellness Non-Drowsy Daytime Cold & Flu Softgel Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg" ], "indications_and_usage": [ "Uses temporarily relieves common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation" ], "set_id": "9a6642bb-ddb8-403b-bcb8-3a8510d706b3", "id": "77109cb6-7ca4-4dfa-9f1c-d8e08c4f8ef4", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg" ] }, { "effective_time": "20130628", "inactive_ingredient": [ "INACTIVE INGREDIENTS benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax" ], "purpose": [ "PURPOSES Protectant Protectant Vasoconstrictor" ], "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 and/or intrarectal use only 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 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 condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain If pregnant or breast-feeding, 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." ], "when_using": [ "When using this product do not exceed the recommended daily dosage unless directed by a doctor." ], "questions": [ "QUESTIONS? To report adverse drug event call: (800) 616-2417" ], "spl_product_data_elements": [ "Mineral Oil, Petrolatum and Phenylephrine HCl mineral oil, petrolatum, phenylephrine HCl MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID BUTYLATED HYDROXYANISOLE CORN OIL GLYCERIN LANOLIN LANOLIN ALCOHOLS METHYLPARABEN PARAFFIN PROPYLPARABEN WATER SHARK LIVER OIL THYME TOCOPHEROL WHITE WAX smooth yellow ointment" ], "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" ], "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 a soft cloth before applying ointment. when first opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum thoroughly cleanse applicator after each use and replace cover also apply ointment to external area children under 12 years of age: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION store at 20-25°C (68-77°F)" ], "stop_use": [ "Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton HEMORRHOIDAL OINTMENT TAMPER-EVIDENT: Do not use if printed \"safety sealed\" overwrap is broken or missing. Prompt, Soothing Relief from painful burning, itching and discomfort Shrinks swollen hemorrhoidal tissue Protects irritated tissue Relieves internal and external discomfort NET WT 2 OZ (56.8 g) Principal Display Panel - 56.8 g Tube Carton" ], "indications_and_usage": [ "USES helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue and relieves burning 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": "9ea3b4ec-ad69-45fc-91d6-ffd9ee312591", "id": "d763cf0b-a67f-490c-852d-ce795fa6e62f", "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 Mineral oil 14% Petrolatum 71.9% Phenylephrine HCl 0.25%" ] }, { "effective_time": "20140305", "inactive_ingredient": [ "Inactive ingredients Inactive ingredients: Butylated hydroxytoluene (BHT), Butylated hydroxyanisole (BHA)" ], "purpose": [ "Purpose Purpose Relieves occassional constipation (irregularity)." ], "keep_out_of_reach_of_children": [ "Keep Out Of Reach Of Children Keep Out Of Reach Of Children Keep this and all drugs out of the reach of children In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Warnings Do not use: If you have difficulty swallowing. In children under 12 years of age. If you are pregnant. For a period longer than 1 week. If you are bedridden or aged." ], "spl_product_data_elements": [ "DYNAREX LAXATIVE MINERAL OIL MINERAL OIL MINERAL OIL butylated hydroxytoluene Butylated hydroxyanisole" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage & Administration Directions Do not take with meals Take only at bedtime May be taken as a single daily dose or in divided doses. age dose adults and children over 12 years 1 to 3 tablespoons (15 to 45 ml) Maximum 3 tablespoons (45ml) in 24 hours children under 12 years Consult a doctor" ], "spl_unclassified_section": [ "Other information Other information Keep tightly closed Protect from sunlight" ], "package_label_principal_display_panel": [ "Principal Display Panel Dynarex Mineral Oil Laxative 4270 Min oil.jpg 4270 Mineral oil" ], "indications_and_usage": [ "Indications & Usage Indications & Usage For relief of occassional constipation (irregularity). When using this product Do not take with meals Take only at bedtime Ask a doctor before use if you have Stomach reflux Abdominal pain, nausea, or vomiting Notice a sudden change in bowel habits that persist over a period of 2 weeks Stop use and ask a doctor if Rectal bleeding or failure to have a bowel movementafter use. These could be signs of a serious condition." ], "set_id": "a56267f3-2a8b-4a70-9ce5-233ddbf13db6", "id": "4b1b8aeb-f368-46a2-8bfd-516e2a1436b9", "active_ingredient": [ "Active Ingredient Active Ingredient Purpose Mineral oil Intestinal lubricant" ], "dosage_and_administration_table": [ "
age dose
adults and children over 12 years 1 to 3 tablespoons (15 to 45 ml) Maximum 3 tablespoons (45ml) in 24 hours
children under 12 years Consult a doctor
" ] }, { "effective_time": "20110701", "inactive_ingredient": [ "Inactive Ingredients petrolatum, lanolin, cod liver oil (contains vitamin A and vitamin D), purified water, talcum, methylparaben, fragrance, butylated hydroxyanisole" ], "purpose": [ "Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness" ], "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. 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 the reach of children. If swallowed get medical help or contact a Poison Control Center right away" ], "spl_product_data_elements": [ "Walgreen Maximum Strength Diaper Rash ZINC OXIDE ZINC OXIDE ZINC OXIDE PETROLATUM LANOLIN METHYLPARABEN BUTYLATED HYDROXYANISOLE WATER TALC COD LIVER OIL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - change wet and soiled diapers promptly - cleanse the diaper area - allow to dry - apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged Other information Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness" ], "set_id": "a56d9cc7-9118-4bfa-8e66-6275a8570d96", "id": "64e1ba10-f315-47f9-ae64-1d47d6e5a241", "active_ingredient": [ "Active ingredient Purpose Zinc Oxide. 40%.......................................Skin protectant" ] }, { "effective_time": "20101005", "inactive_ingredient": [ "Inactive ingredients butylated hydroxyanisole (BHA), boric acid, carbamide peroxide, hydroxyalkyl-phosphonate 30%, sodium alginate, sodium borate" ], "purpose": [ "Purpose Lubricant Lubricant" ], "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 Do not use • if solution changes color or becomes cloudy When using this product • do not touch tip of container to any surface to avoid contamination • replace cap after using Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye, or if condition worsens or persists for more than 72 hours 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 touch tip of container to any surface to avoid contamination • replace cap after using" ], "questions": [ "Questions or Comments? Toll Free Product Information or to Report a Serious Side Effect Associated with use of the product Call: 1-800-553-5340" ], "spl_product_data_elements": [ "Soothe glycerin and propylene glycol GLYCERIN GLYCERIN PROPYLENE GLYCOL PROPYLENE GLYCOL BUTYLATED HYDROXYANISOLE BORIC ACID SODIUM BORATE CARBAMIDE PEROXIDE SODIUM ALGINATE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • instill 1 to 2 drop(s) in the affected eye(s) as needed or directed by your doctor Other Information • store at 15º-25ºC (59º-77ºF)" ], "stop_use": [ "Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye, or if condition worsens or persists for more than 72 hours" ], "do_not_use": [ "Do not use • if solution changes color or becomes cloudy" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NEW! Bausch & Lomb Soothe® Lubricant Eye Drops Xtra Hydration DRY EYE THERAPY Dual Action Moisturizes for fast relief Restores your eye' natural balance Long Lasting Relief Restores the mucin layer of tears Sterile 0.5 FL OZ (15 mL) Bausch & Lomb Soothe XH carton" ], "indications_and_usage": [ "Uses • Relieves dryness of the eye • Prevents further irritation" ], "set_id": "ab98750f-60c2-4c73-afee-97e4dcafb312", "id": "c4db1cf0-fc4a-49be-80a8-4b9ca2c72122", "active_ingredient": [ "Active ingredient Glycerin (0.55%) Propylene Glycol (0.55%)" ] }, { "effective_time": "20120606", "inactive_ingredient": [ "INACTIVE INGREDIENT butylated hydroxyanisole, butylated hydroxytoluene, glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, polysorbate 80" ], "purpose": [ "PURPOSE pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for children even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS For rectal use only Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child inserts: • more than 5 suppositories in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Do not use • if your child is allergic to acetaminophen • 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 a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs • you need to use this product for pain for more than 5 days continuously Severe or recurrent pain, or high or continued fever may indicate a serious illness." ], "questions": [ "QUESTIONS call 1-800-922-1038 Monday-Friday 9am-4pm EST" ], "spl_product_data_elements": [ "Acetaminophen Acetaminophen Acetaminophen Acetaminophen Butylated Hydroxyanisole Butylated Hydroxytoluene Glyceryl Monostearate Hydrogenated Coconut Oil Peg-100 Stearate Polysorbate 80 Packaging Carton" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Directions This product does not contain directions or complete warnings for adult use. • do not use more than directed • remove foil wrapper • insert suppository well up into rectum • children 3-6 years: • 1 suppository every 4 to 6 hours while symptoms persist • do not exceed 5 suppositories in any 24-hour period • children under 3 years: ask a doctor" ], "spl_unclassified_section": [ "Other Information • for your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open. • store at 8˚-25˚C (46˚-77˚F)" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SEE NEW WARNINGS INFORMATION READ AND KEEP CARTON FOR NEW LIVER WARNING NDC 54868-5624-0 12 rectal suppositories Acetaminophen Suppositories USP 120 mg ASPIRIN FREE Pain Reliever • Fever Reducer 50 Rectal Suppositories" ], "indications_and_usage": [ "USES temporarily • reduces fever • relieves minor aches, pains, and headache" ], "set_id": "c383bf5b-7043-4f0c-bddb-590aea545859", "id": "301ec476-d899-4616-be96-910bcb384d08", "active_ingredient": [ "ACTIVE INGREDIENT (in each rectal suppository) Acetaminophen 120 mg" ] }, { "effective_time": "20150709", "inactive_ingredient": [ "INACTIVE INGREDIENTS benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax" ], "purpose": [ "PURPOSES Protectant Protectant Vasoconstrictor" ], "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 and/or intrarectal use only 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 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 condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain If pregnant or breast-feeding, 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." ], "when_using": [ "When using this product do not exceed the recommended daily dosage unless directed by a doctor." ], "questions": [ "QUESTIONS OR COMMENTS? Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374." ], "spl_product_data_elements": [ "PREPARATION H mineral oil, petrolatum, phenylephrine hydrochloride PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM BENZOIC ACID BUTYLATED HYDROXYANISOLE CORN OIL GLYCERIN LANOLIN LANOLIN ALCOHOLS METHYLPARABEN PARAFFIN PROPYLPARABEN WATER THYME WHITE WAX TOCOPHEROL" ], "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" ], "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 a soft cloth before applying ointment. when first opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum thoroughly cleanse 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 years of age: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION store at 20-25°C (68-77°F)" ], "stop_use": [ "Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days introduction of applicator into the rectum causes additional pain" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 28 g Tube Label THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING. PREPARATION H ® HEMORRHOIDAL OINTMENT Prevents Further Irritation Prompt, Soothing Relief from Painful Burning, Itching and Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Relieves Internal and External Discomfort NET WT 1 OZ (28 g) Principal Display Panel - 28 g Tube Label", "PRINCIPAL DISPLAY PANEL - 28 g Tube Carton PREPARATION H ® HEMORRHOIDAL OINTMENT Prevents Further Irritation Prompt, Soothing Relief from Painful Burning, Itching and Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Relieves Internal and External Discomfort NET WT 1 OZ (28 g) Principal Display Panel - 28 g Tube Carton" ], "indications_and_usage": [ "USES helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue and relieves burning 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": "ce789c2a-1d38-4c5f-923e-9d4dab751c01", "id": "d22dbae7-26e4-46f8-a825-8af5426f5b13", "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 Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%" ] }, { "effective_time": "20110628", "inactive_ingredient": [ "Inactive Ingredients aloe barbadensis leaf juice, butylated hydroxyanisole, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate SE, laureth-23, methylparaben, mineral oil, penthenol, propylene glycol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, tocopheryl acetate, xanthan gum" ], "purpose": [ "Use s - for temporary relief of 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" ], "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. Ask a doctor before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged 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 - do not put into rectum by using fingers or any mechanical device or applicator - use only the provided dispensing cap Stop use and ask a doctor if - bleeding occurs - 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 breast feeding, ask a health professional before use. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away" ], "spl_product_data_elements": [ "Rexall Maximum Strength Hemorrhoidal PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER CETYL ALCOHOL GLYCERYL MONOSTEARATE CARBOXYMETHYLCELLULOSE SODIUM LAURETH-23 MINERAL OIL PANTHENOL GLYCERIN GLYCERIN PETROLATUM PETROLATUM PROPYL GALLATE STEARYL ALCOHOL PROPYLENE GLYCOL SODIUM BENZOATE STEARETH-2 STEARETH-20 .ALPHA.-TOCOPHEROL ACETATE, D- XANTHAN GUM ALOE VERA LEAF BUTYLATED HYDROXYANISOLE EDETATE DISODIUM CITRIC ACID MONOHYDRATE METHYLPARABEN PROPYLPARABEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "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 dispensing cap well, then gently insert cap partway into the anus. - thoroughly cleanse dispensing cap after each use and replace cover - children under 12 years of age: ask a doctor" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Use s - for temporary relief of 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 Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F) - for lot number and expiration date, see crimp of tube or see box" ], "set_id": "d56768b7-dc2b-4527-a4ba-d3d462c32be3", "id": "600fd5a6-bacf-4d4d-b6da-8a1bdca490c0", "active_ingredient": [ "Active ingredients Purpose Glycerin 14.4%.................................................Protectant Petrolatum 15%...............................................Protectant Phenylephrine Hydrochloride 0.25%...................Vasoconstrictor Pramoxine HCl 1%...........................................Local anesthetic" ] }, { "effective_time": "20150506", "inactive_ingredient": [ "Inactive ingredients butylated hydroxyanisole, cod liver oil (contains vitamin A and vitamin D), fragrance, lanolin, methylparaben, petrolatum, purifeid water, talc" ], "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 1-800-222-1222" ], "warnings": [ "Warning s For external use onl y 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" ], "spl_product_data_elements": [ "Little Ones Maximum Strength ZINC OXIDE ZINC OXIDE ZINC OXIDE BUTYLATED HYDROXYANISOLE COD LIVER OIL VITAMIN A VITAMIN D LANOLIN METHYLPARABEN PETROLATUM WATER TALC" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions change wet and soiled diapers promptly cleanse the diaper area allow to dry apply paste liberally as often as necessary, with each diaper change especially at bedtime or anytime when exposure to wet diapers may be prolonged" ], "storage_and_handling": [ "Other information store between 20- 25C (68-77F)" ], "package_label_principal_display_panel": [ "copy of label" ], "indications_and_usage": [ "Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness" ], "set_id": "f69d762a-870d-4f53-ab5f-fb5d665242af", "id": "6c604f5c-0a25-407a-a543-082f9be261d7", "active_ingredient": [ "Active Ingredient Zinc Oxide 40 %" ] } ] }