{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 61 } }, "results": [ { "effective_time": "20120514", "inactive_ingredient": [ "Inactive Ingredients: Corn Oil, Light Mineral Oil, Vitamin A Palmitate, Vitamin D" ], "purpose": [ "Purpose-Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external use only. Avoid contact with eyes. on deep puncture wounds, animal bites, or serious burns. Stop use and ask a doctor if condition worsens, symptoms last for more than 7 days or clear up and occur again within a few days." ], "spl_product_data_elements": [ "A and D Petrolatum PETROLATUM PETROLATUM VITAMIN A PALMITATE ERGOCALCIFEROL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Apply liberally as needed Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Use with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged." ], "package_label_principal_display_panel": [ "MM1 H and H AD Carton.jpg" ], "indications_and_usage": [ "Uses-Temporarily protects minor cuts, scrapes, and sunburn. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects of wind and cold weather." ], "set_id": "00bc354f-9f7b-4288-9bbe-a140a6643d20", "id": "41f08daa-55b1-42ac-b2e2-4a8dd8883536", "active_ingredient": [ "Active Ingredient (in each gram): White Petrolatum 93.5%" ] }, { "questions_table": [ "
NDC Strength Quantity/Form Color Source Prod. Code
53808-0834-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2030
" ], "effective_time": "20130911", "inactive_ingredient": [ "Inactive ingredients benzoic acid, carnauba wax, FD&C blue #1, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever Pain reliever Pain reliever aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tables in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask Doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis. or kidney disease you are taking a diuretic high blood pressure you have asthma Ask a doctor or pharmacist before use any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs os stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children Overdose Warning In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments 1-800-468-7746 This product is supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0834-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2030 This product was Manufactured By: Novartis Pharmaceuticals Corporation One Health Plaza And Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States" ], "spl_product_data_elements": [ "Excedrin Extra Strength Acetaminophen, Aspirin (NSAID), and Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE BENZOIC ACID CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE DIMETHICONE 410 FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE HYPROMELLOSE 2910 (15 MPA.S) LIGHT MINERAL OIL POLYSORBATE 20 POVIDONE PROPYLENE GLYCOL SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE White E" ], "ask_doctor": [ "Ask Doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis. or kidney disease you are taking a diuretic high blood pressure you have asthma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed (see Overdose Warning) drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tables in 24 hours children under 12 years: ask a doctor Other information store at controlled room temperature 20 0 - 25 0 C (68 0 - 77 0 F) read all product information before using. Keep this box for important information" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs os stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "Principal Display Panel Excedrin E.S. Tablets" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps" ], "set_id": "081ca362-bfd1-4eeb-b2a1-b47f05ee0e2f", "id": "afaee673-4a3b-4204-b20b-4dd229c26dfd", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition" ], "overdosage": [ "Overdose Warning In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20111114", "inactive_ingredient": [ "Inactive Ingredients Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water" ], "purpose": [ "Purpose Skin Protectant" ], "keep_out_of_reach_of_children": [ "- Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately." ], "warnings": [ "Warnings - Do not use over deep or puncture wounds, infections, or lacerations. For external use only. - When using this product do not get into eyes. If contact occurs, rinse eyes throughout with water. - Stop use and ask a doctor if condition worsens or does not improve with 7 days." ], "spl_product_data_elements": [ "Rash Relief Clear Petrolatum Dimethicone Petrolatum Petrolatum Dimethicone Dimethicone Mineral Oil Cyclomethicone Lanolin Microcrystalline Wax Hexamethyldisiloxane Water Cholecalciferol Vitamin A Palmitate" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. - Shake bottle well before use. - Spray 4-6 inches from skin. No rub-in is required. - Apply liberally as often as necessary, with each diaper change, and especially at bedtime or anytime exposure to we diapers is prolonged." ], "package_label_principal_display_panel": [ "Enter section text here RRCL" ], "indications_and_usage": [ "Uses: Protects minor skin irritation due to diaper rash and helps seal out wetness." ], "set_id": "0b5753aa-b591-4d6e-8341-fcc9456299b6", "id": "f678f128-0e58-49db-a47d-21ab8f8c74a3", "active_ingredient": [ "Active Ingredients Dimethicone 20% Petrolatum 25%" ] }, { "effective_time": "20110919", "inactive_ingredient": [ "Inactive ingredients purified water USP, glyceryl stearate, isopropyl palmitate NF, light mineral oil NF, ozokerite, propylene glycol USP, stearyl alcohol NF, PEG-1500 stearate, poloxamer 188, propylene glycol monostearate NF, steareth-20, laureth-23, sodium metabisulfite NF, sodium lauryl sulfate NF, anhydrous citric acid USP, fragrance, methylparaben NF, dimethicone, propylparaben NF, edetate disodium, butylated hydroxyanisole" ], "purpose": [ "Purpose Skin Lightener" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact a poison control center right away." ], "warnings": [ "Warnings For external use only. Do not use • On inflamed or broken skin • On children under 12 years of age unless directed by a physician Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away." ], "when_using": [ "When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure" ], "questions": [ "Questions? 1-800-900-6389 (24 hours a day, 7 days a week)" ], "spl_product_data_elements": [ "Esoterica Nighttime with Moisturizers hydroquinone hydroquinone hydroquinone water glyceryl monostearate isopropyl palmitate mineral oil ceresin propylene glycol stearyl alcohol polyethylene glycol 1500 poloxamer 188 steareth-20 laureth-23 sodium metabisulfite sodium lauryl sulfate anhydrous citric acid methylparaben dimethicone propylparaben edetate disodium butylated hydroxyanisole PROPYLENE GLYCOL MONOPALMITOSTEARATE" ], "ask_doctor": [ "Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor • For sensitive skin, test overnight on small area (inside elbow) • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a healthcare professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: MEDICIS The Dermatology Company ® Scottsdale, AZ 85256" ], "storage_and_handling": [ "Other information • Store at room temperature • Tamper-evident carton • Serious side effects may be reported to the phone number provided in the Questions? section below." ], "do_not_use": [ "Do not use • On inflamed or broken skin • On children under 12 years of age unless directed by a physician" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 70 g Carton Skin Lightener with Moisturizers NDC # 99207-290-02 E ESOTÉRICA ® ESOTÉRICA ® FADE CREAM NIGHTTIME With Moisturizers Net Wt. 2.5 oz (70 g) carton.jpg" ], "indications_and_usage": [ "Use Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptives." ], "set_id": "12adc34c-e65d-4679-b2c3-ab9ff5f615e8", "id": "8f190ff1-ad4c-4e71-9006-38aa705d381b", "active_ingredient": [ "Active ingredients Hydroquinone USP 2%" ] }, { "effective_time": "20131015", "inactive_ingredient": [ "Inactive ingredients edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan *may contain this ingredient" ], "purpose": [ "Purpose Nighttime sleep-aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid alcoholic drinks." ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "spl_product_data_elements": [ "NightTime Sleep Aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN LIGHT MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL P50;A99;S90" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland" ], "other_safety_information": [ "Other information store at 15°-30°C (59°-86°F)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness." ], "do_not_use": [ "Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal Display Panel ** Compare to the active ingredient in Unisom® SleepGels® Maximum Strength NightTime Sleep-Aid DIPHENHYDRAMINE HCl, 50 mg • LIQUID FILLED CAPSULES • SAFE, NON-HABIT FORMING Softgels ONE SOFTGEL PER DOSE **This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®. DISTRIBUTED BY ONPOINT, INC. 2 PARAGON DRIVE MONTVALE, NJ 07645 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.", "Package Label Live Better Maximum Strength NightTime Sleep Aid Softgel Diphenhydramine HCl 50 mg" ], "indications_and_usage": [ "Use for relief of occasional sleeplessness." ], "set_id": "16dc2588-c125-4e11-8077-2b42cd88424e", "id": "7c8a719a-2182-425f-8211-a7f91eb7b923", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient (in each softgel) Diphenhydramine HCl 50 mg" ] }, { "effective_time": "20150921", "inactive_ingredient": [ "Inactive ingredients Cetyl alcohol, Glycerin, Light mineral oil, Squalane, Steareth-2, Stearic acid, Tocopheryl acetate, dand White petrolatum" ], "purpose": [ "Purpose First aid antibiotic First aid antibiotic First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use if you are allergic to any of the ingredients in the eyes over large areas of body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Pentrexcilina Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B CETYL ALCOHOL GLYCERIN LIGHT MINERAL OIL STEARETH-2 SQUALANE STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE, D- PETROLATUM BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B" ], "ask_doctor": [ "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age or older: clean the affected area apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor" ], "storage_and_handling": [ "Other information store at 15° - 25° C (59° to 77°F)" ], "do_not_use": [ "Do not use if you are allergic to any of the ingredients in the eyes over large areas of body" ], "package_label_principal_display_panel": [ "Package label panel Pentrexcilina Triple Antibiotic carton" ], "indications_and_usage": [ "Uses First aid to help prevent infection in minor: cuts scrapes burns" ], "set_id": "2045df84-49da-7261-e054-00144ff8d46c", "id": "2045df84-49db-7261-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units" ] }, { "effective_time": "20110810", "inactive_ingredient": [ "Inactive ingredients Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Steareth-w, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum" ], "purpose": [ "Purpose First aid antibiotic First aid antibiotic First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use if you are allergic to any of the ingredients Ask a doctor before use if you have serious burns deep or puncture wounds animal bites When using this product do not use in the eyes do not apply over large areas of the body Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use in the eyes do not apply over large areas of the body" ], "spl_product_data_elements": [ "Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B CETYL ALCOHOL GLYCERIN LIGHT MINERAL OIL STEARETH-2 SQUALANE STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE, D- PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have serious burns deep or puncture wounds animal bites" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age or older: clean the affected area apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 59 ° to 77 ° F" ], "package_label_principal_display_panel": [ "Package label panel Triple Antibiotic Ointment image of a carton" ], "indications_and_usage": [ "Uses First aid to help prevent infection in minor: cuts scrapes burns" ], "set_id": "2a34a7c5-e5fa-4fe2-aef9-bb378d45994b", "id": "4d4d5279-f24f-47b4-aac0-79fef99b7006", "active_ingredient": [ "Active ingredient Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units" ] }, { "effective_time": "20101005", "inactive_ingredient": [ "Inactive ingredients BHA, cod liver oil (high in vitamins A and D), fragrance, lanolin, light mineral oil, methylparaben, petrolatum, purified water, talc, tartrazine yellow #4 (FD and C yellow #4)" ], "purpose": [ "Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect skin from wetness helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away" ], "warnings": [ "For external use only" ], "when_using": [ "When using this product avoid contact with the eyes" ], "spl_product_data_elements": [ "WESTERN FAMILY DIAPER RASH ZINC OXIDE ZINC OXIDE ZINC OXIDE COD LIVER OIL LANOLIN LIGHT MINERAL OIL METHYLPARABEN PETROLATUM WATER TALC" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Proudly Distributed By: Western Family Foods, Inc. P.O. Box 4057, Portland, OR 97208 U.S.A. Copyright 2010 Marca Registrada www.westernfamily.com" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve within 7 days" ], "storage_and_handling": [ "Other information store at 20 o to 25 o C (68 o to 77 o F) Lot No. and Exp. Date: see box or see crimp of tube" ], "do_not_use": [ "Do not use over deep or puncture wounds, infections or lacerations" ], "package_label_principal_display_panel": [ "Enter section text here image of carton label" ], "indications_and_usage": [ "Directions change wet and soiled diapers promptly, cleanse the diaper area and allow to dry apply ointment liberally as often as necessary, with each diaper change especially at bedtime or anytime when exposure to wet diapers may be prolonged" ], "set_id": "2c0f0018-6389-4282-aa18-416b9329b8ca", "id": "65933290-eab5-456c-9ea5-c9d5ff3c614c", "active_ingredient": [ "Active Ingredient Purpose Zinc oxide, 40% ........................................................................Skin protectant" ] }, { "effective_time": "20120911", "inactive_ingredient": [ "Inactive ingredients light mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use if you have in case of deep or puncture wounds, animal bites or serious burns Stop use and ask a doctor if condition persists or gets worse rash or other allergic reaction develops Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Best Choice Bacitracin Zinc Bacitracin Zinc BACITRACIN ZINC BACITRACIN MINERAL OIL PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have in case of deep or puncture wounds, animal bites or serious burns" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if condition persists or gets worse rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at room temperature" ], "do_not_use": [ "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Package label Best Choice Bacitracin Zinc image of carton label" ], "indications_and_usage": [ "Uses first aid to help prevent infection in minor cuts, scrapes and burns" ], "set_id": "2eb93432-5a2e-4eee-a7b2-5e1af126b4a3", "id": "385a2ea6-5c85-4230-b4a6-7b7db5529ceb", "active_ingredient": [ "Active ingredient (in each gram) Bacitracin Zinc 500 units" ] }, { "effective_time": "20120716", "inactive_ingredient": [ "Inactive ingredients Cetyl alcohol, Glycerin, Light mineral oil, Steareth-2, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum" ], "purpose": [ "Purpose First aid antibiotic First aid antibiotic First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Ask a doctor before use if you have serious burns deep or puncture wounds animal bites When using this product do not use in the eyes do not apply over large areas of the body Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients" ], "when_using": [ "When using this product do not use in the eyes do not apply over large areas of the body" ], "spl_product_data_elements": [ "Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B CETYL ALCOHOL GLYCERIN LIGHT MINERAL OIL STEARETH-2 SQUALANE STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE, D- PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have serious burns deep or puncture wounds animal bites" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age or older: clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 59 ° to 77 ° F" ], "do_not_use": [ "Do not use if you are allergic to any of the ingredients" ], "package_label_principal_display_panel": [ "Package label panel Triple Antibiotic Ointment image of carton label" ], "indications_and_usage": [ "Uses First aid to help prevent infection in minor: cuts scrapes burns" ], "set_id": "3758e221-df99-48b5-81e5-e9adaaba592f", "id": "90c12c45-4c04-440f-9b35-729d1fc962b6", "active_ingredient": [ "Active ingredients Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units" ] }, { "effective_time": "20110104", "inactive_ingredient": [ "INACTIVE INGREDIENTS COD LIVER OIL, FRAGRANCE, LIGHT MINERAL OIL, MICROCRYSTALLINE WAX, PARAFFIN." ], "purpose": [ "PURPOSE SKIN PROTECTANT SKIN PROTECTANT" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS SYMPTOMS LAST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS DO NOT USE ON DEEP OR PUNCTURE WOUNDS ANIMAL BITES SERIOUS BURNS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER." ], "questions": [ "QUESTIONS OR COMMENTS 1-866-695-3030" ], "spl_product_data_elements": [ "VITAMINS A AND D DIAPER RASH LANOLIN AND PETROLATUM LANOLIN LANOLIN PETROLATUM PETROLATUM COD LIVER OIL LIGHT MINERAL OIL MICROCRYSTALLINE WAX PARAFFIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR SKIN PROTECTANT USE APPLY AS NEEDED FOR DIAPER RASH USE CHANGE WET AND SOILED DIAPERS PROMPTLY CLEAN THE DIAPER AREA, AND ALLOW TO DRY APPLY OINTMENT AS OFTEN AS REQUIRED, WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS SYMPTOMS LAST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS" ], "storage_and_handling": [ "OTHER INFORMATION STORE BETWEEN 20 DEGREES CELSIUS TO 25 DEGREES CELSIUS (68 DEGREES FAHRENHEIT TO 77 DEGREES FAHRENHEIT)." ], "do_not_use": [ "DO NOT USE ON DEEP OR PUNCTURE WOUNDS ANIMAL BITES SERIOUS BURNS" ], "package_label_principal_display_panel": [ "IMAGE OF RA1" ], "indications_and_usage": [ "USES HELPS TREAT AND PREVENT DIAPER RASH. TEMPORARILY PROTECTS MINOR: CUTS SCRAPES BURNS. TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFE OR CRACKED SKIN AND LIPS. HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER." ], "set_id": "3b775462-6eca-4a78-97ee-e4881132b6c9", "id": "9cec1a5c-9771-4b6f-8594-c32a817d9f4a", "active_ingredient": [ "ACTIVE INGREDIENT LANOLIN 15.5 PERCENT PETROLATUM 53.4 PERCENT" ] }, { "effective_time": "20130822", "purpose": [ "Active ingredients (in each caplet) Purposes Acetaminophen 250mg pain reliever Aspirin 250mg (NSAID) This Product is not manufactured or distributed by Novartis Consumer Healthcare, Inc. Owner of registered trademark Excedrin ® . Pain reliever Caffeine 65mg pain reliever aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "questions": [ "Question and comment? 1(856) 2863646" ], "pregnancy_or_breast_feeding": [ "any new symptoms appear if pregnant or breast-feeding, ask health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "Other information store at controlled room temperature 20°-25°C(68°-77°F) See end flap or expiration date and lot number." ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains due to: Headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps." ], "set_id": "3ba45f29-d6b9-4bda-a830-9999791013cb", "id": "53f2e6c3-b328-4867-a442-3bc74cfaf799", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout or arthritis any other drug, or are under a doctor's care for any serious condition" ], "active_ingredient": [ "Active ingredients (in each caplet) Purposes Acetaminophen 250mg pain reliever Aspirin 250mg (NSAID) This Product is not manufactured or distributed by Novartis Consumer Healthcare, Inc. Owner of registered trademark Excedrin ® . Pain reliever Caffeine 65mg pain reliever aid" ], "inactive_ingredient": [ "Inactive ingredients benzoic acid, carnauba wax, FD&C blue#1, hydroxypropylcellulose, Hypromellose,light mineral oil, microcrystalline cellulose, polysorbate 20, Povidone, propylene glycol,simethicone emulsion, Sorbitan monolaurate, stearic acid, titanium dioxide." ], "warnings": [ "Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention. Allergy alert aspirin may cause a severe allergic reaction which may include : hives facial swelling asthma (wheezing) shock Liver warning This product contains acetaminophen. Severe liver damage may occur if you take. adult takes more than 8 caplets in 24 hours, which is the maximum daily amount. Child takes more than 5 caplets in 24 hours. with other drugs containing acetaminophen. 3 or more alcoholic drinks every day while using this product. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using product. take more or for a longer time than directed. Caffeine warning The recommended dose of this product contains about as much as caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any 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 you have a liver disease stomach bleeding warning applies to you you have not been drinking fluids you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have lost a lot of fluids due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout or arthritis any other drug, or are under a doctor's care for any serious condition Stop use and ask a doctor if an allergic reaction occurs. seek medical help right away you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear if pregnant or breast-feeding, ask health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. Overdose Warning In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "SohMed Pain Reliever Acetaminophen, Aspirin, and Caffeine Acetaminophen Acetaminophen Aspirin Aspirin Caffeine Caffeine CARNAUBA WAX BENZOIC ACID HYDROXYPROPYL CELLULOSE (TYPE H) FD&C BLUE NO. 1 HYPROMELLOSES LIGHT MINERAL OIL CELLULOSE, MICROCRYSTALLINE POLYSORBATE 20 POVIDONES PROPYLENE GLYCOL DIMETHICONE SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE CRX" ], "ask_doctor": [ "Ask a doctor before use if you have a liver disease stomach bleeding warning applies to you you have not been drinking fluids you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have lost a lot of fluids due to vomiting or diarrhea" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years and over : take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: asks a doctor." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by : Sohm, Inc. 6920 Knott Ave., Suit A-C, Buena Park, CA 90621" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. seek medical help right away you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any drug containing acetaminophen (prescription or nonprescription).If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purposes
Acetaminophen 250mg pain reliever
Aspirin 250mg (NSAID)This Product is not manufactured or distributed by Novartis Consumer Healthcare, Inc. Owner of registered trademark Excedrin®. Pain reliever
Caffeine 65mg pain reliever aid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton SohMed ™ NDC XXXXXXXXXX * Compare to the active ingredients in Excedrin ® Extra Strength Pain Reliever Acetaminophen 250 mg, Aspirin 250 mg (NSAID) Caffeine 65 mg Relieves minor aches and pains 24 Caplets Principal Display Panel - 24 Caplet Bottle Carton" ], "purpose_table": [ "
Active ingredients (in each caplet) Purposes
Acetaminophen 250mg pain reliever
Aspirin 250mg (NSAID)This Product is not manufactured or distributed by Novartis Consumer Healthcare, Inc. Owner of registered trademark Excedrin®. Pain reliever
Caffeine 65mg pain reliever aid
" ], "overdosage": [ "Overdose Warning In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20111116", "inactive_ingredient": [ "Inactive Ingredients Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum" ], "purpose": [ "Purpose Antifungal / Skin Protectant" ], "keep_out_of_reach_of_children": [ "- Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately" ], "warnings": [ "Warnings - Ask a doctor before use on children under the age of two. For external use only. - When using this product do not get into eyes. - Stop use and ask a doctor if: irritation develops; there is no improvement within 4 weeks for athlete's foot or ringworm; or within 2 weeks for jock itch." ], "spl_product_data_elements": [ "Rash Relief Antifungal Miconazole Miconazole Nitrate Miconazole Dimethicone Dimethicone Mineral Oil Cyclomethicone Lanolin Microcrystalline Wax Hexamethyldisiloxane Water Cholecalciferol Vitamin A Palmitate Petrolatum Zinc Oxide Zinc Oxide" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - Clean the affected area and dry thoroughly. - Shake bottle well before use. - Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician. No rub-in is required." ], "package_label_principal_display_panel": [ "RRAF" ], "indications_and_usage": [ "Uses: Treats jock itch, ringworm, and athlete's foot" ], "set_id": "4114c685-acd1-4c65-842b-1cb7840852dc", "id": "2d4f02ce-0bf1-4f31-9eb8-ee649af17ec2", "active_ingredient": [ "Active Ingredients Miconazole Nitrate 2% Dimethicone 10% Petrolatum 10%" ] }, { "effective_time": "20140207", "ask_doctor_table": [ "
liver disease heart disease thyroid disease trouble urinating due to an enlarged prostate gland high blood pressure diabetes
" ], "purpose": [ "Active ingredients (in each caplet) Purposes Acetaminophen 325 mg Pain reliever Phenylephrine HCl 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 use more than directed" ], "questions": [ "Questions or comments? 1-855-619-7900" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at controlled room temperature 20°-25°C (68°-77°F) read all product information before using. Keep this box for important information." ], "indications_and_usage": [ "Uses temporarily relieves: headache minor aches and pains nasal congestion sinus congestion and pressure helps clear nasal passages; shrinks swollen membranes" ], "set_id": "424961db-c6dd-49d2-8d60-413f39f8db7d", "id": "ba30bedb-b54d-447c-a17c-088c0fe5cd38", "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 caplet) Purposes Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients benzoic acid, carnauba wax, corn starch, FD&C blue # 1, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, stearic acid, titanium dioxide, talc,gelatin, polyethylene glycol sodium starch glycolate, sodium benzoate, hydroxypropylmethyl cellulose" ], "warnings": [ "Warnings Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets 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 Do not use if you are 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. 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 heart disease thyroid disease trouble urinating due to an enlarged prostate gland high blood pressure diabetes Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if any new symptoms occur you get nervous, dizzy, or sleepless painful area is red or swollen pain or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts for more than 3 days 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": [ "ConRX Pain Reliever Sinus Headache Phenylephrine Hydrochloride and Acetaminophen Phenylephrine Hydrochloride Phenylephrine Acetaminophen Acetaminophen Benzoic Acid Carnauba Wax Starch, Corn Fd&C Blue No. 1 Sodium Benzoate light mineral oil Magnesium Stearate Cellulose, Microcrystalline Polysorbate 20 Povidones Propylene Glycol Polyethylene Glycols Stearic acid Titanium dioxide Talc Gelatin Sodium Starch Glycolate Type A Corn Hypromelloses CRX" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease thyroid disease trouble urinating due to an enlarged prostate gland high blood pressure diabetes" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed adults and children 12 years and over: take 2 caplets every 4 hours; not more than 12 caplets in 24 hours children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if any new symptoms occur you get nervous, dizzy, or sleepless painful area is red or swollen pain or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts for more than 3 days" ], "do_not_use": [ "Do not use if you are 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. 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" ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purposes
Acetaminophen 325 mg Pain reliever
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box See New Warnings Information & Directions Compare to the Active Ingredients in EXCEDRIN* ® SINUS HEADACHE ConRx ® PAIN RELIEVER SINUS HEADACHE Acetaminophen and Phenylephrine HCl Aspirin Free • Pain Reliever / Nasal Decongestant TO OPEN PUSH IN TAB AND PULL OUT Compare to the Active Ingredients in EXCEDRIN ® SINUS HEADACHE 2 Caplets Each Pouch Principal Display Panel - 50 x 2 Caplet Pouch Box" ], "purpose_table": [ "
Active ingredients (in each caplet) Purposes
Acetaminophen 325 mg Pain reliever
Phenylephrine HCl 5 mg Nasal decongestant
" ], "warnings_table": [ "
liver disease heart disease thyroid disease trouble urinating due to an enlarged prostate gland high blood pressure diabetes
" ] }, { "effective_time": "20130714", "inactive_ingredient": [ "Inactive Ingredients Aloe barbadensis extract, benzyl alcohol, coconut oil, cod liver oil ( contains vitamin A & Vitamin D), fragrance, glyceryl oleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water" ], "purpose": [ "Active ingredients Purpose Dimethicone 1% Diaper rash Cream Zinc Oxide 10% Diaper rash Cream" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not get into eyes" ], "spl_product_data_elements": [ "A AND A Diaper Rash cream DIMETHICONE and ZINC OXIDE DIMETHICONE DIMETHICONE ALOE VERA LEAF YELLOW WAX CAPRYLYL GLYCOL SAFFLOWER OIL CHOLECALCIFEROL ETHYLHEXYLGLYCERIN GLYCERIN HEXYLENE GLYCOL MINERAL OIL PEG-100 STEARATE PHENOXYETHANOL POTASSIUM SORBATE WATER VITAMIN A PALMITATE SORBITAN MONOSTEARATE .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM ZINC OXIDE ZINC OXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days" ], "storage_and_handling": [ "Other information store between 20°C to 25 °C ( 68° to 77°F)" ], "active_ingredient_table": [ "
Active ingredients Purpose
Dimethicone 1% Diaper rash Cream
Zinc Oxide 10% Diaper rash Cream
" ], "package_label_principal_display_panel": [ "Principal Display Panel A+A Diaper Rash Cream with DIMETHICONE AND ZINC OXIDE Helps treat and calm diaper rash Allows Skin to heal naturally A+A Diaper Rash Cream A+A Diaper Rash Cream" ], "indications_and_usage": [ "Uses helps treat and prevent diaper rash protects minor skin irritation due to diaper rash and helps seal out wetness" ], "set_id": "45a42b10-e42a-4e98-95b8-777f995c5e09", "id": "f050e1de-72f4-41b2-b8c7-c6e3caf441da", "purpose_table": [ "
Active ingredients Purpose
Dimethicone 1% Diaper rash Cream
Zinc Oxide 10% Diaper rash Cream
" ], "active_ingredient": [ "Active ingredients Purpose Dimethicone 1% Diaper rash Cream Zinc Oxide 10% Diaper rash Cream" ] }, { "effective_time": "20140912", "inactive_ingredient": [ "Inactive ingredients cod liver oil, fragrance, light mineral oil, microcrystalline wax, paraffin." ], "purpose": [ "Purpose Diaper Rash Ointment Skin protectant" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product • do not get into eyes Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days Do not use on • deep or puncture wounds • animal bites • serious burns" ], "spl_product_data_elements": [ "A D and L Original Diaper Rash Skin Lanolin, Petrolatum LANOLIN LANOLIN PETROLATUM PETROLATUM COD LIVER OIL MICROCRYSTALLINE WAX PARAFFIN LIGHT MINERAL OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • for skin protectant use: apply as needed • for diaper rash use: • change wet and soiled diapers promptly • cleanse the diaper area, and allow to dry • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged" ], "spl_unclassified_section": [ "Other information store at between 20° to 25°C (68° to 77°F)" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel buybuyBABY TM diaper rash ointment & skin protectant Rich in Vitamins A&D Helps Treat & Prevent Diaper Rash Forms a Protective Barrier on Skin to Help Seal Out Wetness NET WT 16 OZ (454 g) MADE EXPRESSLY FOR buybuyBABY ™ 650 LIBERTY AVENUE, UNION, NJ 07083 ©BUY BUY BABY INC. WWW.BUYBUYBABY.COM MADE IN ISRAEL 0G343 B1 B1 Peel for Full Labeling Carton Label Carton Label" ], "indications_and_usage": [ "Uses • helps treat and prevent diaper rash • temporarily protects minor: • cuts • scrapes • burns • temporarily protects and helps relieve chapped, chafed or cracked skin and lips • protects chafed skin due to diaper rash and helps seal out wetness" ], "set_id": "4db80eb6-0cb6-43a0-a808-ff69538dff80", "id": "4db80eb6-0cb6-43a0-a808-ff69538dff80", "active_ingredient": [ "Active ingredient Lanolin, 15.5% Petrolatum, 53.4%" ] }, { "effective_time": "20111116", "inactive_ingredient": [ "Inactive Ingredients Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Protein, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum" ], "purpose": [ "Purpose Skin Protectant ." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately." ], "warnings": [ "Warnings - For external use only . - When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. For external use only. - Stop use and ask a doctor if condition worsens or does not improve in 7 days." ], "spl_product_data_elements": [ "Rash Relief Silver Dimethicone Zinc Oxide Dimethicone Dimethicone Zinc Oxide Zinc Oxide Mineral Oil Cyclomethicone Lanolin Microcrystalline Wax Hexamethyldisiloxane Water Cholecalciferol Vitamin A Palmitate Petrolatum Casein Silver" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - Cleanse the skin area thoroughly. - Shake bottle well before use. - Spray 4-6 inches from skin using firm/quick trigger motion. No rub-in is required. Coating slowly dries over time. - Reapply 1-3 times per day or as directed by health professional." ], "package_label_principal_display_panel": [ "Enter section text here RRSS" ], "indications_and_usage": [ "Manage moisture, friction, and inflammation: skin folds, incontinence dermatitis, venous stasis/pressure ulcers, wounds" ], "set_id": "4de4d6a4-db9d-4eed-badc-a365af191e84", "id": "129b5c74-29e9-4827-a58a-47b5a9cac8e8", "active_ingredient": [ "Active Ingredients Dimethicone 20% Petrolatum 25% Silver 25 ppm" ] }, { "effective_time": "20120716", "inactive_ingredient": [ "Inactive ingredients light mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Bacitracin Zinc Bacitracin Zinc BACITRACIN ZINC BACITRACIN LIGHT MINERAL OIL PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 20 - 25C (68 - 77F)" ], "do_not_use": [ "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients" ], "package_label_principal_display_panel": [ "Package label Bacitracin Zinc Ointment image of carton label" ], "indications_and_usage": [ "Uses helps prevent infection in minor cuts scrapes burns" ], "set_id": "52621048-fc8d-461a-8c0f-e3ba16dd20d0", "id": "64e859d4-1ed6-4b9f-9dbe-dd45ef7aa1b2", "active_ingredient": [ "Active ingredient (in each gram) Bacitracin Zinc 500 units" ] }, { "effective_time": "20130911", "purpose": [ "Purpose Pain reliever Pain reliever Pain reliever aid" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? This product is supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0835-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2039 This product was distributed By: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 1-800-468-7746 And Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "Other information store at controlled room temperature 20°-25°C (68°-77°F) read all product information before using. Keep this box for important information. TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION”IS BROKEN OR MISSING" ], "indications_and_usage": [ "Uses treats migraine" ], "set_id": "540c34a3-a4dc-4dd7-8ef9-53092b7a86bb", "id": "b7ef153b-d459-49e9-ac4a-c7744a7fc9ed", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) diabetes gout arthritis under a doctor’s care for any serious condition taking any other drug taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer" ], "active_ingredient": [ "Active ingredient Acetaminophen 250 mg Aspirin 250 mg (NSAID) * Caffeine 65 mg * nonsteroidal anti-inflammatory drug" ], "questions_table": [ "
NDC Strength Quantity/Form Color Source Prod. Code
53808-0835-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2039
" ], "inactive_ingredient": [ "Inactive Ingredients benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide" ], "warnings": [ "Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 2 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning : The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat." ], "spl_product_data_elements": [ "EXCEDRIN MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE BENZOIC ACID CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE HYPROMELLOSE 2208 (100000 MPA.S) LIGHT MINERAL OIL POLYSORBATE 20 POVIDONE PROPYLENE GLYCOL SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE White Capsule shaped tablet" ], "ask_doctor": [ "Ask Doctor before use if you have never had migraines diagnosed by a health professional you have a headache that is different from your usual migraines you have the worst headache of your life you have fever and stiff neck you have headaches beginning after or caused by head injury, exertion, coughing or bending you experienced your first headache after the age of 50 you have daily headaches you have a migraine so severe as to require bed rest you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers you have vomiting with your migraine headache" ], "boxed_warning": [ "TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION”IS BROKEN OR MISSING" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed adults: take 2 tablets with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 tablets in 24 hours, unless directed by a doctor under 18 years of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better your migraine is not relieved or worsens after first dose new or unexpected symptoms occur ringing in the ears or loss of hearing occurs" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist" ], "package_label_principal_display_panel": [ "Principal Display EXCEDRIN MIGRAINE CAPLETS" ] }, { "effective_time": "20140306", "inactive_ingredient": [ "Inactive ingredients Light Mineral Oil, White Petrolatum" ], "purpose": [ "Purpose: First aid to help prevent infection." ], "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 Dosage and Administration Directions: clean the affected areas apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily. may be covered with a sterile bandage Indications and Usage First aid to help prevent infection in: minor cuts scrapes burns Stop Use and ask a doctor if: the condition persists or gets worse, or if a rash or other allergic reaction develops. Do Not Use if: if you are allergic to any of the ingredients in the eyes over large areas of the body longer than 1 week unless directed by a doctor" ], "spl_product_data_elements": [ "Bacitracin Bacitracin MINERAL OIL PETROLATUM BACITRACIN BACITRACIN" ], "ask_doctor": [ "Ask a doctor before use: in case of deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and Administration Directions: clean the affected areas apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily. may be covered with a sterile bandage" ], "stop_use": [ "Stop Use and ask a doctor if: the condition persists or gets worse, or if a rash or other allergic reaction develops." ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30° C (59°-86° F)" ], "do_not_use": [ "Do Not Use if: if you are allergic to any of the ingredients in the eyes over large areas of the body longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel Bacitracin Ointment BP Bacitracin.jpg Bacitracin" ], "indications_and_usage": [ "Indications and Usage First aid to help prevent infection in: minor cuts scrapes burns" ], "set_id": "54a400eb-a0e7-465f-9bc5-c526d169a961", "id": "e231c3af-75a8-42db-8a8c-743d92ec25d5", "active_ingredient": [ "Active ingredient Purpose Bacitracin Zinc (Equal to 500 Bacitracin Units) First Aid Antibiotic" ] }, { "effective_time": "20111018", "inactive_ingredient": [ "Inactive Ingredients Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum" ], "purpose": [ "Purpose Skin Protectant Uses: Treats and prevents minor skin irritation - itching - diaper rash - feeding tubes sites, or lacerations." ], "keep_out_of_reach_of_children": [ "- Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately." ], "warnings": [ "Warnings - Do not use over deep or puncture wounds, infections, or lacerations. For external use only. - When using this product do not get into eyes. If contact occurs, rinse eyes throughout with water. - Stop use and ask a doctor if condition worsens or does not improve with 7 days." ], "spl_product_data_elements": [ "Rash Relief Zinc Oxide Dimethicone Zinc Oxide Zinc Oxide Dimethicone Dimethicone Mineral Oil Cyclomethicone Lanolin Microcrystalline Wax Hexamethyldisiloxane Water Cholecalciferol Vitamin A Palmitate Petrolatum" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions - Cleanse skin area, and allow to dry. - Shake bottle well before use. - Spray 4-6 inches from skin. No rub-in is required. - Apply liberally as often as necessary- each diaper change with incontinence care- to soothe and protect irritated skin." ], "package_label_principal_display_panel": [ "RR25" ], "indications_and_usage": [ "Uses: Treats and prevents minor skin irritation - itching - diaper rash - feeding tubes sites, or lacerations." ], "set_id": "54d7250e-6aaa-4fc8-88b3-2fee58ebaf73", "id": "807982a5-c00f-476e-a20e-3315826756ba", "active_ingredient": [ "Active Ingredients Dimethicone 20% Zinc Oxide 25%" ] }, { "spl_product_data_elements": [ "Eagle Brand Medicated Oil Aromatic camphor, menthol, methyl salicylate METHYL SALICYLATE SALICYLIC ACID LIGHT MINERAL OIL MENTHOL MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) EUCALYPTUS OIL SPIKE LAVENDER OIL" ], "active_ingredient": [ "Active Ingredients Camphor 7% Menthol 16% Methyl Salicylate 35%" ], "purpose": [ "Purpose External Analgesic" ], "indications_and_usage": [ "Uses For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains." ], "warnings": [ "Warnings For external use only When using this product Avoid getting into the eyes or on mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use otherwise than as directed. 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, discontinue use of this product and consult a doctor. 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 Centre right away." ], "when_using": [ "When using this product Avoid getting into the eyes or on mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use otherwise than as directed." ], "stop_use": [ "Stop use and ask a doctor if Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor." ], "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 If swallowed, get medical help or contact a Poison Control Centre right away." ], "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor." ], "other_safety_information": [ "Other information Store below 86 o F (30 o C)." ], "inactive_ingredient": [ "Inactive ingredients eucalyptus oil, light mineral oil, spike lavender oil" ], "questions": [ "Questions? If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769." ], "package_label_principal_display_panel": [ "Package Label 36ml NDC: 24ml NDC: 3ml NDC: 36ml Unit Box 24ml Unit Box 3ml Unit Box" ], "set_id": "54e45d89-e8c3-6fc3-e063-6394a90aac4e", "id": "54e45d89-e8c4-6fc3-e063-6394a90aac4e", "effective_time": "20150615", "version": "1", "openfda": { "application_number": [ "M017" ], "brand_name": [ "Eagle Brand Medicated Oil Aromatic" ], "generic_name": [ "CAMPHOR, MENTHOL, METHYL SALICYLATE" ], "manufacturer_name": [ "Borden Company (Private) Limited" ], "product_ndc": [ "43405-099" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "METHYL SALICYLATE", "MENTHOL", "CAMPHOR (SYNTHETIC)" ], "rxcui": [ "1654728" ], "spl_id": [ "54e45d89-e8c4-6fc3-e063-6394a90aac4e" ], "spl_set_id": [ "54e45d89-e8c3-6fc3-e063-6394a90aac4e" ], "package_ndc": [ "43405-099-36", "43405-099-24", "43405-099-03" ], "is_original_packager": [ true ], "unii": [ "LAV5U5022Y", "L7T10EIP3A", "5TJD82A1ET" ] } }, { "spl_product_data_elements": [ "Eagle Brand Medicated Roll On Refresh camphor, menthol PEPPERMINT OIL PEPPERMINT MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) BETA CAROTENE NONIVAMIDE CHERRY LIGHT MINERAL OIL D&C RED NO. 17 CLOVE OIL" ], "active_ingredient": [ "Active Ingredients Camphor 2.2% Menthol 14%" ], "purpose": [ "Purpose External Analgesic" ], "indications_and_usage": [ "Uses For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains, and itching associated with • insect bites." ], "warnings": [ "Warnings For external use only . When using this product Avoid getting into the eyes or on mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use otherwise than as directed. Stop use and ask doctor if Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. 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 Centre right away." ], "when_using": [ "When using this product Avoid getting into the eyes or on mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use otherwise than as directed." ], "stop_use": [ "Stop use and ask doctor if Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor." ], "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 If swallowed, get medical help or contact a Poison Control Centre right away." ], "other_safety_information": [ "Other Information Store below 86°F (30°C)." ], "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor." ], "inactive_ingredient": [ "Inactive Ingredients beta carotene,clove oil, D&C Red No.17, fragrance,light mineral oil" ], "questions": [ "Questions If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769." ], "package_label_principal_display_panel": [ "Package Label 8ml NDC: 43405-098-08 8 ml NDC: 43405-098-08" ], "set_id": "567b6820-fb52-630e-e063-6294a90a8bf8", "id": "567b6820-fb53-630e-e063-6294a90a8bf8", "effective_time": "20150701", "version": "1", "openfda": { "application_number": [ "M017" ], "brand_name": [ "Eagle Brand Medicated Roll On Refresh" ], "generic_name": [ "CAMPHOR, MENTHOL" ], "manufacturer_name": [ "Borden Company (Private) Limited" ], "product_ndc": [ "43405-098" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "PEPPERMINT OIL", "CAMPHOR (SYNTHETIC)" ], "spl_id": [ "567b6820-fb53-630e-e063-6294a90a8bf8" ], "spl_set_id": [ "567b6820-fb52-630e-e063-6294a90a8bf8" ], "package_ndc": [ "43405-098-08" ], "is_original_packager": [ true ], "unii": [ "AV092KU4JH", "5TJD82A1ET" ] } }, { "spl_product_data_elements": [ "Eagle Brand Medicated Oil Refresh camphor, menthol CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) PEPPERMINT OIL PEPPERMINT MENTHOL BETA CAROTENE NONIVAMIDE CHERRY LIGHT MINERAL OIL D&C RED NO. 17 CLOVE OIL" ], "active_ingredient": [ "Active Ingredients Camphor 2.2% Menthol 14%" ], "purpose": [ "Purpose External Analgesic" ], "indications_and_usage": [ "Uses For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains, and itching associated with • insect bites." ], "warnings": [ "Warnings For external use only. When using this product Avoid getting into the eyes or on mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use otherwise than as directed. 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, discontinue use of this product and consult a doctor. 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 Centre right away." ], "when_using": [ "When using this product Avoid getting into the eyes or on mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Do not use otherwise than as directed." ], "stop_use": [ "Stop use and ask a doctor if Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor." ], "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 If swallowed, get medical help or contact a Poison Control Centre right away." ], "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor." ], "other_safety_information": [ "Other Information Store below 86°F (30°C)." ], "inactive_ingredient": [ "Inactive Ingredients beta carotene,clove oil, D&C Red No.17, fragrance,light mineral oil" ], "questions": [ "Questions If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769." ], "package_label_principal_display_panel": [ "Package Label 3ml NDC: 43405-097-03 24ml NDC: 43405-097-24 36ml NDC: 43405-097-36 3 24 36" ], "set_id": "56cab78c-d4e5-3bf7-e063-6294a90a6749", "id": "56cab78c-d4e6-3bf7-e063-6294a90a6749", "effective_time": "20150701", "version": "1", "openfda": { "application_number": [ "M017" ], "brand_name": [ "Eagle Brand Medicated Oil Refresh" ], "generic_name": [ "CAMPHOR, MENTHOL" ], "manufacturer_name": [ "Borden Company (Private) Limited" ], "product_ndc": [ "43405-097" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "CAMPHOR (SYNTHETIC)", "PEPPERMINT OIL" ], "spl_id": [ "56cab78c-d4e6-3bf7-e063-6294a90a6749" ], "spl_set_id": [ "56cab78c-d4e5-3bf7-e063-6294a90a6749" ], "package_ndc": [ "43405-097-03", "43405-097-24", "43405-097-36" ], "is_original_packager": [ true ], "unii": [ "5TJD82A1ET", "AV092KU4JH" ] } }, { "effective_time": "20131006", "inactive_ingredient": [ "Inactive ingredients light mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings For external use only. Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "triple antibiotic bacitracin, neomycin, polymyxin B BACITRACIN BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM LIGHT MINERAL OIL Translucent" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54569-3398-0 Relabeled by: A-S Medication Solutions Libertyville, IL 60048 3398-0.jpg" ], "indications_and_usage": [ "Uses first aid to help prevent infection in minor: • cuts • scrapes • burns" ], "set_id": "6465a585-0c2a-4b9d-96f7-e2a3880e7738", "id": "4df4898e-c86e-4fa5-88b2-b8530301ec06", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns" ], "active_ingredient": [ "Active ingredient (in each gram) Bacitracin 400 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate" ] }, { "effective_time": "20130806", "inactive_ingredient": [ "Inactive ingredients Light Mineral Oil, White Petrolatum" ], "purpose": [ "Purpose: First aid to help prevent infection." ], "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 Dosage and Administration Directions: clean the affected areas apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily. may be covered with a sterile bandage Indications and Usage First aid to help prevent infection in: minor cuts scrapes burns Stop Use and ask a doctor if: the condition persists or gets worse, or if a rash or other allergic reaction develops. Do Not Use if: if you are allergic to any of the ingredients in the eyes over large areas of the body longer than 1 week unless directed by a doctor Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away" ], "spl_product_data_elements": [ "Bacitracin Bacitracin MINERAL OIL PETROLATUM BACITRACIN BACITRACIN" ], "ask_doctor": [ "Ask a doctor before use: in case of deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and Administration Directions: clean the affected areas apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily. may be covered with a sterile bandage" ], "stop_use": [ "Stop Use and ask a doctor if: the condition persists or gets worse, or if a rash or other allergic reaction develops." ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30° C (59°-86° F)" ], "do_not_use": [ "Do Not Use if: if you are allergic to any of the ingredients in the eyes over large areas of the body longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel Bacitracin Ointment: Gal Bacitracin.jpg Gal Bacitracin" ], "indications_and_usage": [ "Indications and Usage First aid to help prevent infection in: minor cuts scrapes burns" ], "set_id": "68449090-6c59-4046-b721-ebe572de0595", "id": "2a35f493-11e4-49ab-bacd-3b1eede3d97a", "active_ingredient": [ "Active ingredient Purpose Bacitracin 500 Units Antibiotic" ] }, { "effective_time": "20100825", "inactive_ingredient": [ "Inactive ingredients Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Steareth-w, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum" ], "purpose": [ "Purpose First aid antibiotic First aid antibiotic First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use if you are allergic to any of the ingredients Ask a doctor before use if you have serious burns deep or puncture wounds animal bites When using this product do not use in the eyes do not apply over large areas of the body Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use in the eyes do not apply over large areas of the body" ], "spl_product_data_elements": [ "Triple Antibiotic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B CETYL ALCOHOL GLYCERIN LIGHT MINERAL OIL STEARETH-2 SQUALANE STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE, D- PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have serious burns deep or puncture wounds animal bites" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age or older: clean the affected area apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 59 ° to 77 ° F" ], "package_label_principal_display_panel": [ "Package label panel Triple Antibiotic Ointment image of a carton" ], "indications_and_usage": [ "Uses First aid to help prevent infection in minor: cuts scrapes burns" ], "set_id": "7b7ecb27-8414-4933-bc13-405ef9032167", "id": "949a5beb-b5f4-473f-82db-81fe75e86a4c", "active_ingredient": [ "Active ingredient Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units" ] }, { "effective_time": "20120514", "inactive_ingredient": [ "Inactive Ingredients: Corn Oil, Light Mineral Oil, Vitamin A Palmitate, Vitamin D, Vitamin E" ], "purpose": [ "Purpose-Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external use only. Do not use in eyes, on deep puncture wounds, animal bites, or serious burns or for more than 1 week unless directed by a doctor. Stop use and ask a doctor if: A rash or allergic reaction develops. Condition worsens, persists, or recurs." ], "spl_product_data_elements": [ "A and D plus E Petrolatum PETROLATUM PETROLATUM VITAMIN A PALMITATE ERGOCALCIFEROL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Apply liberally as needed Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Use with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged." ], "package_label_principal_display_panel": [ "MM1 MM2 A and D 4 ounce tube_0001.jpg A and D 13 ounce jar_0001.jpg" ], "indications_and_usage": [ "Uses-Temporarily protects minor cuts, scrapes, and sunburn. Helps treat and prevent diaper rash. Protects chafed skin or minor skin irritation associated with diaper rash and helps seal out wetness. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects of wind and cold weather." ], "set_id": "83bf1e5f-02e4-44b1-8cef-8751607546a1", "id": "44d74207-2e5b-47bd-87ac-aba45145fe40", "active_ingredient": [ "Active Ingredient (in each gram): White Petrolatum 93.5%" ] }, { "effective_time": "20100930", "inactive_ingredient": [ "Inactive ingredients BHA, cod liver oil (high in vitamin A and D), fragrance, lanolin, methylparaben, petrolatum, talc and purified water, light mineral oil, tartrazine yellow #4 (FD and C yellow #4)" ], "purpose": [ "Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect skin from wetness" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only" ], "when_using": [ "When using this product avoid contact with the eyes" ], "spl_product_data_elements": [ "PREMIER VALUE DIAPER RASH ZINC OXIDE ZINC OXIDE ZINC OXIDE COD LIVER OIL LANOLIN METHYLPARABEN PETROLATUM TALC WATER LIGHT MINERAL OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Distributed By: Chain Drug Consortium, LLC. 3301 N.W. Boca Raton Blvd., Suite 101 Boca Raton, FL 33431" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve within 7 days" ], "storage_and_handling": [ "Other information store at 20 o to 25 o C (68 o to 77 o F) Lot No. and Exp. Date: see box or see crimp of tube" ], "do_not_use": [ "Do not use over deep or puncture wounds, infections or lacerations" ], "package_label_principal_display_panel": [ "Enter section text here image of carton label" ], "indications_and_usage": [ "Directions change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged" ], "set_id": "878c4d70-a14d-4924-8288-440784d7bb5a", "id": "e67f37e1-e527-4045-b3eb-689f4addfcc4", "active_ingredient": [ "Active Ingredient Purpose Zinc oxide, 40% .....................................................................Skin protectant" ] }, { "effective_time": "20120817", "inactive_ingredient": [ "Inactive ingredients eucalyptus oil, light mineral oil" ], "purpose": [ "Purpose Pain reliever/antiseptic" ], "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. Do not induce vomiting before contacting medical help or a Poison Control Center" ], "warnings": [ "Warnings for external use only" ], "when_using": [ "When using this product avoid contact with the eyes do not bandage" ], "spl_product_data_elements": [ "Major Camphor and Phenol Antiseptic CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) PHENOL PHENOL EUCALYPTUS OIL LIGHT MINERAL OIL" ], "ask_doctor": [ "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions clean the affected area adults and children 2 years of age or older: apply a small amount of this product on the area 1 to 3 times daily children under 2 years of age: consult a doctor" ], "stop_use": [ "Stop use and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days" ], "do_not_use": [ "Do not use in the eyes or apply over large areas of the body" ], "package_label_principal_display_panel": [ "Major Camphor & Phenol Antiseptic Liquid 1.5 fl. oz (44ml) label image image of label Major Camphor & Phenol Antiseptic Liquid 1.5 fl. oz (44ml) carton image image of carton", "Major Camphor & Phenol Antiseptic Liquid 1.5 fl. oz (44ml) carton image image of carton" ], "indications_and_usage": [ "USES first aid to help reduce the risk of infection associated with minor cuts, scrapes, minor burns, and insect bites for the temporary relief of pain and itching associated with minor burns, sunbrun, minor cuts, scrapes, fever blisters and cold sores" ], "set_id": "9282885f-b364-439b-b91b-7fcf4f734121", "id": "1daa463f-7e91-47cb-a16d-7a95ca295b2e", "active_ingredient": [ "Active ingredient Camphorated phenol (camphor, 10.8% and phenol, 4.7%)" ] }, { "effective_time": "20120301", "inactive_ingredient": [ "Inactive ingredients aloe vera gel, light mineral oil, white petrolatum" ], "purpose": [ "Uses first aid to help prevent infection in minor cuts scrapes burns" ], "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" ], "spl_product_data_elements": [ "FAMILY CARE BACITRACIN BACITRACIN BACITRACIN BACITRACIN ALOE VERA LEAF LIGHT MINERAL OIL PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Distributed By UNITED EXCHANGE CORP. 17211 Valley View Ave. Cerritos, CA 90703 USA Made in Korea" ], "stop_use": [ "Stop use and ask a doctor if the condition persists or gets worse a rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 15 o to 25 o C (59 o to 77 o F) Lot No. and Exp. Date: see box or see crimp of tube" ], "do_not_use": [ "Do not use in the eyes if you are allergic to any of the ingredients over large areas of the body longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Enter section text here image of carton label" ], "indications_and_usage": [ "Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "set_id": "955c1539-3cb9-486c-b758-92a7a712f628", "id": "76cd96fa-f9d8-4b01-8a97-f8218e524b8b", "active_ingredient": [ "Active ingredients (each gram contains) Purpose Bacitracin 500 units .......................................................................................First Aid Antibiotic" ] }, { "effective_time": "20140307", "inactive_ingredient": [ "Inactive ingredients cod liver oil, fragrance, light mineral oil, microcrystalline wax, paraffin." ], "purpose": [ "Purpose Diaper Rash Ointment Skin protectant" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only." ], "when_using": [ "When using this product • do not get into eyes" ], "spl_product_data_elements": [ "Baby Care Vitamins A and D Lanolin LANOLIN LANOLIN PETROLATUM PETROLATUM COD LIVER OIL LIGHT MINERAL OIL MICROCRYSTALLINE WAX PARAFFIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • for skin protectant use apply as needed • for diaper rash use: • change wet and soiled diapers promptly • cleanse the diaper area, and allow to dry • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged" ], "stop_use": [ "Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days" ], "spl_unclassified_section": [ "Other Information store at 20° to 25°C (68° to 77°F)" ], "do_not_use": [ "Do Not Use • deep or puncture wounds • animal bites • serious burns" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel baby care vitamins A&D ointment diaper rash ointment skin protectant NET WT 4 OZ. (113 g) SATISFACTION GUARANTEE IF YOU’RE NOT SATISFIED, WE’LL HAPPILY REFUND YOUR MONEY. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE CAMP HILL, PA 17011 MANUFACTURED IN ISRAEL 0G327 83 T1 Carton Label Carton Label" ], "indications_and_usage": [ "Uses • helps treat and prevent diaper rash • temporarily protects minor: ● cuts ● scrapes ● burns • temporarily protects and helps relieve chapped, chafed or cracked skin and lips • protects chafed skin due to diaper rash and helps seal out wetness" ], "set_id": "96838b7f-aa9c-4ac3-ae87-065ae98f419a", "id": "96838b7f-aa9c-4ac3-ae87-065ae98f419a", "active_ingredient": [ "Active ingredient Lanolin, 15.5% Petrolatum, 53.4%" ] }, { "effective_time": "20120501", "inactive_ingredient": [ "Inactive ingredients BHA, cod liver oil (high in vitamin A and D), fragrance, lanolin, methylparaben, petrolatum, talc and purified water, light mineral oil, tartrazine yellow #4 (FD and C yellow #4)" ], "purpose": [ "Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect skin from wetness" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only" ], "when_using": [ "When using this product avoid contact with the eyes" ], "spl_product_data_elements": [ "COTTONTAILS DIAPER RASH ZINC OXIDE ZINC OXIDE ZINC OXIDE BUTYLATED HYDROXYTOLUENE COD LIVER OIL MINERAL OIL METHYLPARABEN POLYSORBATE 60 LANOLIN TALC PETROLATUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DISTRIBUTED BY: AMERICAN SALES COMPANY 4201 WALDEN AVENUE, LANCASTER, NY 14086 www.Care1.info Made in Korea" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve within 7 days" ], "storage_and_handling": [ "Other information store at 20 o to 25 o C (68 o to 77 o F) Lot No. and Exp. Date: see box or see crimp of tube" ], "do_not_use": [ "Do not use over deep or puncture wounds, infections or lacerations" ], "package_label_principal_display_panel": [ "Enter section text here image of carton label" ], "indications_and_usage": [ "Directions change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged" ], "set_id": "9e55a124-7f42-4c05-8834-7eb8e33ab8d9", "id": "d7d1e9e7-2bcc-4e74-9007-80d9fb3adee2", "active_ingredient": [ "Active Ingredient Purpose Zinc oxide, 40% .....................................................................Skin protectant" ] }, { "effective_time": "20130729", "inactive_ingredient": [ "Inactive Ingredients Colloidal Silicon Dioxide, Eucalyptus Oil, Glycerin, Light Mineral Oil" ], "purpose": [ "Purpose External Analgesic" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting medical help or a Poison Control Center. For adults and children over 2 years of age." ], "warnings": [ "Warnings For external use only. Do not use over large areas of the body or with a bandage. Ask a doctor before use if you have a deep puncture wound, animal bites, or serious burns. When using this product: avoid contact with eyes. Rinse with water to remove. Seek medical help or contact a Poison Control Center. Stop use and consult a doctor if: conditions worsen or last more than 7 days, or if it clears up and returns again in a few days." ], "spl_product_data_elements": [ "ChapIce Camphor Phenol Gel Camphor, Phenol LIGHT MINERAL OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) SILICON DIOXIDE GLYCERIN PHENOL PHENOL EUCALYPTUS OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children over 2 years clean the affected area and apply directly to a cold sore or fever blister 1 to 3 times daily. Do not bandage." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Front and Back of Blister Card" ], "indications_and_usage": [ "Uses For the temporary relief of pain and itching associated with cold sores and fever blisters. First Aid to help prevent infection." ], "set_id": "a0f07fe2-63e7-4908-ac4f-7c25d396738b", "id": "a0f07fe2-63e7-4908-ac4f-7c25d396738b", "active_ingredient": [ "Active ingredient Camphor 10.8%, Phenol 4.7%" ] }, { "effective_time": "20131006", "inactive_ingredient": [ "Inactive ingredients light mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings For external use only. Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "triple antibiotic bacitracin, neomycin, polymyxin B BACITRACIN BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM LIGHT MINERAL OIL Translucent" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54569-2295-0 Relabeled by: A-S Medication Solutions Libertyville, IL 60048 2295-0.jpg" ], "indications_and_usage": [ "Uses first aid to help prevent infection in minor: • cuts • scrapes • burns" ], "set_id": "a2435956-bbc8-4058-acd3-7ac01734fe2e", "id": "4638c51e-5d71-4ae5-9233-50adb0e38cea", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns" ], "active_ingredient": [ "Active ingredient (in each gram) Bacitracin 400 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate" ] }, { "effective_time": "20100101", "inactive_ingredient": [ "Inactive ingredients benzoic acid, carnauba wax, D&C red # 27 lake, D&C yellow # 10 lake, FD&C blue # 1 lake, FD&C red # 40, hypromellose, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, pregelatinized starch, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away. 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 8 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat." ], "questions": [ "Questions or comments 1-800-468-7746 Distr. By: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 Visit us at www.excedrin.com" ], "spl_product_data_elements": [ "EXCEDRIN TENSION HEADACHE Acetaminophine, Caffeine ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE BENZOIC ACID CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE D&C RED NO. 27 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 HYPROMELLOSE LIGHT MINERAL OIL MAGNESIUM STEARATE POLYSORBATE 20 POVIDONE PROPYLENE GLYCOL SORBITAN MONOLAURATE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE Red Tablet Shape ETH" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours" ], "pregnancy_or_breast_feeding": [ "Pregnancy or Breast Feeding ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if any new symptoms occur painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days" ], "storage_and_handling": [ "Other information store at controlled room temperature 20°-25°C (68°-77°F) read all product information before using. Keep this box for important information." ], "do_not_use": [ "Do not use if you are 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." ], "package_label_principal_display_panel": [ "Principal Display Tension Headache Excedrin TH Tablets" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: • headache • muscular aches" ], "set_id": "abb000e2-d6f1-45da-a7f5-588c28cdc031", "id": "6807587b-0154-4d1b-a54e-d97185bf9813", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacists taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient Acetaminophen 500 mg Caffeine 65 mg" ] }, { "effective_time": "20110216", "inactive_ingredient": [ "Inactive Ingredients cholecalciferol, cocoa butter, fragrance, light mineral oil, mineral oil, modified lanolin, paraffin, sodium pyruvate, sunflower seed oil, Vitamin A palmitate, Vitamin E (di-alpha tocopherol and di-alpha tocopheryl acetate)" ], "purpose": [ "Active ingredient Purpose Salicylic Acid (0.5%)..............................Acne Medication ______________________________________ Use for the management of acne" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only. _______________________________ Do not use on: - puncture wounds or deep wounds - animal bites - serious burns _______________________________ Keep product away from eyes. _______________________________ Stop use and ask a doctor if: -condition worsens -symptoms last more than 7 days; clear up and occur again within several days" ], "spl_product_data_elements": [ "PETROLATUM PETROLATUM PETROLATUM PETROLATUM MINERAL OIL COCOA BUTTER LANOLIN PARAFFIN VITAMIN A PALMITATE .ALPHA.-TOCOPHEROL ACETATE, DL- CHOLECALCIFEROL SODIUM PYRUVATE SUNFLOWER OIL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions -for diaper rash: - change soiled, wet diapers immediately - cleanse diaper area thoroughly and allow to dry - liberally apply ointment as often as necessary, with each diaper change, especially at bedtime or whenever exposure to wet diapers may be prolonged - for other uses: apply as needed ________________________________ Other information Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)" ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses - helps prevent and treat diaper rash - helps seal out wetness and protects chafed skin due to diaper rash -gives temporary relief to chapped, cracked skin - offers protection from the drying effects of wind and cold weather - gives temporary protection for minor cuts, scrapes and burns" ], "set_id": "af0c4fef-6fcb-41b5-a0a6-70d9b7f625a5", "id": "42c804c8-dcab-4f72-8b93-be5728602a18", "active_ingredient": [ "Active ingredient Purpose White petrolatum 60.4%......................................Skin protectant" ] }, { "effective_time": "20120611", "inactive_ingredient": [ "Inactive Ingredients WATER, WHITE PETROLATUM, LIGHT MINERAL OIL, SORBITAN SESQUILEATE, WHITE BEESWAX, TALC, STEARIC ACID, DIMETHICONE, ALOE VERA GEL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CHOLESTEROL, PANTHENOL, TOCOPHERYL ACETATE, BENZYL ALCOHOL, SODIUM BENZOATE, FRAGRANCE." ], "purpose": [ "Purpose Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only." ], "when_using": [ "When using this product avoid contact with the eyes." ], "questions": [ "Questions or information call toll free: 1-855-ATOPALM" ], "spl_product_data_elements": [ "ATOPALM Diaper Rash ZINC OXIDE ZINC OXIDE ZINC OXIDE WATER PETROLATUM LIGHT MINERAL OIL SORBITAN SESQUIOLEATE WHITE WAX TALC STEARIC ACID DIMETHICONE ALOE VERA LEAF MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA CHOLESTEROL PANTHENOL .ALPHA.-TOCOPHEROL ACETATE BENZYL ALCOHOL SODIUM BENZOATE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Change wet and soiled promptly Cleanse the diaper area and allow to dry. Apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or before any prolonged exposure to wet diapers." ], "spl_unclassified_section": [ "ATOPALM Diaper Rash Cream" ], "stop_use": [ "Stop use and ask a doctor if Conditions worsen symptoms last more than seven days symptoms clear up and occur within a few days." ], "storage_and_handling": [ "Other Information store at 15 degrees - 30 degrees C (59 degrees - 86 degrees F) see carton flap or tube crimp for lot number and expiration date" ], "package_label_principal_display_panel": [ "ATOPALM Diaper Rash Cream 2oz (51141-0237-2) Outerbox1 Outerbox2 InnerPackage" ], "indications_and_usage": [ "Uses Helps treat and prevent diaper rash Protects chafed skin and minor irritation associated with diaper rash Helps seal out wetness." ], "set_id": "b48d733f-a918-481a-88b5-eb36319aa7e9", "id": "da4fcde6-b7da-4442-ba8e-3793aa624d11", "active_ingredient": [ "Active Ingredient Zinc Oxide 10%" ] }, { "effective_time": "20130211", "inactive_ingredient": [ "Inactive ingredients benzoic acid, carnauba wax, corn starch, FD&C blue # 1, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, sucrose,titanium dioxide." ], "purpose": [ "Purpose Alertness aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away" ], "warnings": [ "Warnings For occasional use only Caffeine warning The recommended dose of this product contains about as much coffeube as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use ♦ in children under 12 years of age ♦ as substitue for sleep Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away" ], "questions": [ "Question or comments? 1-800-570-8650" ], "spl_product_data_elements": [ "ConRx Alert Caffeine Caffeine Caffeine BENZOIC ACID CARNAUBA WAX STARCH, CORN FD&C BLUE NO. 1 HYPROMELLOSES LIGHT MINERAL OIL CELLULOSE, MICROCRYSTALLINE POLYSORBATE 20 POVIDONES POLYETHYLENE GLYCOL 6000 DIMETHICONE SORBITAN MONOLAURATE STEARIC ACID SUCROSE TITANIUM DIOXIDE CRX" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ♦ adults and children 12 years of age and over: take ½ to 1 caplet not more often than every 3 to 4 hours" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur" ], "storage_and_handling": [ "Other information ♦ store at room temperature" ], "do_not_use": [ "Do not use ♦ in children under 12 years of age ♦ as substitue for sleep" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 50 Pouch Box Compare to the Active Ingredients in NoDoz MAXIMUM STRENGTH ConRx™ Alert ALERTNESS AID TO OPEN PUSH IN TAB AND PULL OUT Compare to the Active Ingredients in NoDoz 50 Pouches of 2 Caplets Each Principal Display Panel - 50 Pouch Box" ], "indications_and_usage": [ "Use ♦ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness" ], "set_id": "b5479e47-9803-4ed7-bd9a-8eb39da20cea", "id": "c4310dbf-b2cf-4d72-a63a-11b34b148aef", "active_ingredient": [ "Active ingredient (in each caplet) Caffeine 200 mg" ] }, { "effective_time": "20130427", "inactive_ingredient": [ "PETROLATUM LIGHT MINERAL OIL CETOSTEARYL ALCOHOL EDETIC ACID CHLOROCRESOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POLYSORBATE 60 CETETH-20" ], "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": [ "Do not use: Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with eyes. For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "APTRIMAZOLE 1.0% ANTIFUNGAL CREAM CLOTRIMAZOLE CLOTRIMAZOLE CLOTRIMAZOLE PETROLATUM LIGHT MINERAL OIL CETOSTEARYL ALCOHOL EDETIC ACID CHLOROCRESOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POLYSORBATE 60 CETETH-20 offwhite" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Direction: Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Foe athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If conditions persist longer, consult a doctor. This product is not effective on scalp or nails." ], "package_label_principal_display_panel": [ "DISPLAY PANEL product" ], "indications_and_usage": [ "Cures most athlete's foot, jock itch, and ringworm. Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions." ], "set_id": "b54ff8e9-ea77-4702-8c2f-4c693df45547", "id": "8ef19bfe-6e70-4aed-979b-274315278c63", "active_ingredient": [ "CLOTRIMAZOLE" ] }, { "effective_time": "20130820", "inactive_ingredient": [ "Inactive ingredients benzoic acid, corn starch, FD&C blue # 1, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, sucrose, titanium dioxide, carnauba wax." ], "purpose": [ "Purpose Alertness aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For occasional use only Caffeine warning The recommended dose of this product contains about as much caffeine as a cup of cofffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat. Do not use in children under 12 years of age as substitute for sleep Stop use and ask a doctor if drowsiness persists or continues to recur fatigue or If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Question or comments? 1(856) 2863646" ], "spl_product_data_elements": [ "SohMed Alertness Aid Caffeine Caffeine Caffeine BENZOIC ACID CARNAUBA WAX STARCH, CORN FD&C BLUE NO. 1 HYPROMELLOSES LIGHT MINERAL OIL CELLULOSE, MICROCRYSTALLINE POLYSORBATE 20 POVIDONES PROPYLENE GLYCOL DIMETHICONE SORBITAN MONOLAURATE STEARIC ACID SUCROSE TITANIUM DIOXIDE CRX" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: take ½ to 1 caplet not more often than every 3 to 4 hours." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by : Sohm, Inc. 6920 Knott Ave., Suit A-C, Buena Park, CA 90621" ], "stop_use": [ "Stop use and ask a doctor if drowsiness persists or continues to recur fatigue or" ], "storage_and_handling": [ "Other information Store at controlled room temperature 15°-30°C (59°-86°F) See end flap for expiration date and lot number" ], "do_not_use": [ "Do not use in children under 12 years of age as substitute for sleep" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton SohMed ™ NDC XXXXXXXXXX * Compare to the Active Ingredients in Vivarin ® ALERTNESS AID Caffeine Caffeine 200 mg Restore mental alertness or wakefulness 24 Caplets Principal Display Panel - 24 Caplet Bottle Carton" ], "indications_and_usage": [ "Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness" ], "set_id": "b7771094-0d9d-4811-8d60-1e550befef5c", "id": "80ebd529-8309-4e99-aad8-11ea709ca5f7", "active_ingredient": [ "Active ingredients (in each caplet) Caffeine 200 mg" ] }, { "effective_time": "20120820", "inactive_ingredient": [ "Inactive ingredients light mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use if you are allergic to any of the ingredients in the eyes over large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "triple antibiotic bacitracin, neomycin, polymyxin B BACITRACIN BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM LIGHT MINERAL OIL Translucent" ], "openfda": {}, "version": "3998", "dosage_and_administration": [ "Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use if you are allergic to any of the ingredients in the eyes over large areas of the body" ], "package_label_principal_display_panel": [ "Image of Label Image of Label" ], "indications_and_usage": [ "Uses first aid to help prevent infection in minor: cuts scrapes burns" ], "set_id": "bd0166a6-93d2-4b35-beb9-1a770acf249e", "id": "c953233a-30cd-4801-9d64-9704897fbe1f", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns" ], "active_ingredient": [ "Active ingredient (in each gram) Bacitracin 400 units Neomycin 3.5 mg Polymyxin B 5,000 units" ] }, { "effective_time": "20110216", "inactive_ingredient": [ "Inactive Ingredients aloe barbadensis extract, benzyl alcohol, coconut oil, cod liver oil (contains vitamin A and vitamin D), fragrance, glyceryl oleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water" ], "purpose": [ "Active ingredients Purpose Dimethicone 1%........................Diaper rash cream Zinc Oxide 10%........................Diaper rash cream" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. 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 several days" ], "spl_product_data_elements": [ "DIMETHICONE and ZINC OXIDE DIMETHICONE and ZINC OXIDE DIMETHICONE DIMETHICONE WATER MINERAL OIL COCONUT OIL COD LIVER OIL GLYCERYL MONOOLEATE PARAFFIN CERESIN PROPYLENE GLYCOL WHITE WAX BENZYL ALCOHOL ALOE SORBITOL ZINC OXIDE ZINC OXIDE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions - change wet and soiled diapers promptly - cleanse the diaper area and allow to dry - apply cream 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 between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)" ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses - helps treat and prevent diaper rash - protects minor skin irritation due to diaper rash and helps seal out wetness" ], "set_id": "c291d18d-0b53-4418-9047-a2f85c0f2621", "id": "1d59fe5c-0280-435a-acb2-08bf20162755", "active_ingredient": [ "Active ingredients Purpose Dimethicone 1%........................Diaper rash cream Zinc Oxide 10%........................Diaper rash cream" ] }, { "effective_time": "20110216", "inactive_ingredient": [ "Inactive Ingredients colloided silicon dioxide, eucalyptus oil, glycerin, light mineral oil" ], "purpose": [ "Active ingredient Purpose Camphorated phenol (camphor 10.8% and phenoll 4.7%) .........................Pain reliever/antiseptic Use - for the temporary relief of pain and itching associated with cold sores and fever blisters - first aid to help prevent infection" ], "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. Do not induce vomiting before contacting medical help or a Poison Control Center." ], "warnings": [ "Warnings For external use only. ______________________________________________________________________________ Do not use - over large areas of the body - with a bandage ______________________________________________________________________________ Ask a doctor before use if you have - a deep puncture wound - animal bites - serious burns ______________________________________________________________________________ When using this product do not use in or near the eyes. If contact occurs rinse eyes thoroughly with water and obtain medical attention. ______________________________________________________________________________ Stop use and ask a doctor if - condition worsens -symptoms persist for more than 7 days or clear up and occur again within a few days ______________________________________________________________________________ Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. Do not induce vomiting before contacting medical help or a Poison Control Center" ], "spl_product_data_elements": [ "CAMPHOR (SYNTHETIC) and PHENOL CAMPHOR (SYNTHETIC) and PHENOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MINERAL OIL EUCALYPTUS OIL GLYCERIN SILICON DIOXIDE PHENOL PHENOL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - adults and children two years and over: - clean the affected area - apply directly to teh cold sore or fever blister 1 to 3 times daily - Do not bandage Children under two years: ask a doctor Other information Store at room temperature. Avoid excessive heat. Close cover tightly after each use" ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses - for the temporary relief of pain and itching associated with cold sores and fever blisters - first aid to help prevent infection" ], "set_id": "c6459570-e458-47e5-aa01-fdf34f349adc", "id": "4c3f3bbf-4bc8-4637-afdb-338d3817e878", "active_ingredient": [ "Active ingredient Purpose Camphorated phenol (camphor 10.8% and phenoll 4.7%) .........................Pain reliever/antiseptic" ] }, { "effective_time": "20110408", "inactive_ingredient": [ "Inactive Ingredients Aloe Extract, Light Mineral Oil, Softisan 649, White Petrolatum." ], "purpose": [ "Purpose Antifungal" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or consult a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Do not use on children under 2 years of age unless directed by a physician. When using this product, avoid contact with eyes. If irritation occurs or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician. Keep out of reach of children. If swallowed, get medical help or consult a Poison Control Center right away." ], "when_using": [ "When using this product, avoid contact with eyes." ], "spl_product_data_elements": [ "ALOE VESTA ANTIFUNGAL MICONAZOLE NITRATE MICONAZOLE NITRATE MICONAZOLE ALOE VERA LEAF LIGHT MINERAL OIL PETROLATUM white to off-white" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Clean the affected area and dry thoroughly. Apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician. Supervise children in use of this product. For athlete's foot: Pay close attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. For jock itch: use daily for 2 weeks If condition persists longer, consult a physician. This product is not effective on the scalp or nails." ], "stop_use": [ "If irritation occurs or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician." ], "spl_unclassified_section": [ "Other Information Store at 15 o C - 30 o C (59 o F - 86 o F)." ], "do_not_use": [ "Do not use on children under 2 years of age unless directed by a physician." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 43553-3251-2 ConvaTec ALOE VESTA TM Antifungal Ointment TREAT Miconazole Nitrate 2% CURES MOST: Athlete's Foot Ringworm Jock Itch Superficial Yeast Infections NET WT. 2oz.(56g) CSX0647A Case Order No. 325102 Aloe Vesta Antifungal Ointment Label" ], "indications_and_usage": [ "Uses Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions. For the treatment of most superficial skin infections caused by yeast (Candida albicans). Follow a physician's instructions when treating Candida." ], "set_id": "c664e6c6-2a64-409c-9cb6-969d36fe6763", "id": "3cc7fd25-d33f-41ea-8f0c-49402a01e386", "active_ingredient": [ "Active Ingredient Miconazole Nitrate 2%" ] }, { "effective_time": "20120830", "inactive_ingredient": [ "Inactive ingredients cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin" ], "purpose": [ "Active ingredient Purpose Petrolatum 53.4% Skin Protectant Lanolin 15.5% Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use over deep or puncture wounds, infections, or lacerations When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with the eyes" ], "questions": [ "Questions? adverse drug event call: 800-616-2471" ], "spl_product_data_elements": [ "Major Vitamin A and D Skin Protectant Petrolatum and Lanolin Petrolatum Petrolatum Lanolin Lanolin Cod Liver Oil Light Mineral Oil Microcrystalline Wax Paraffin" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply liberally as often as necessary change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry use with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged" ], "spl_unclassified_section": [ "Drug Facts", "Distributed By: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve within 7 days" ], "storage_and_handling": [ "Other information store between 15° and 25°C (59° and 77°F)" ], "do_not_use": [ "For external use only Do not use over deep or puncture wounds, infections, or lacerations" ], "active_ingredient_table": [ "
Active ingredient Purpose
Petrolatum 53.4% Skin Protectant
Lanolin 15.5% Skin Protectant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 454g Jar Label NDC 00904-5843-27 MAJOR ® Compare to the active ingredients in A+D® Original Ointment* Vitamin A & D Ointment DIAPER RASH & ALL PURPOSE SKIN PROTECTANT Treats & Prevents Diaper Rash Helps Heal Dry, Chafed Skin Protects & Soothes Minor Cuts & Burns NET WT 1 LB (454g) PRINCIPAL DISPLAY PANEL - 454g Jar Label" ], "indications_and_usage": [ "Uses helps treat and prevent diaper rash protects chafed skin or minor skin irritation associated with diaper rash and helps seal out wetness helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips provides temporary protection of minor cuts, scrapes, burns and sunburn" ], "set_id": "d7bf90ec-efa5-4345-966f-fe391c1eefff", "id": "1874b9fb-ea3f-4444-a4b7-b20366a2a97a", "purpose_table": [ "
Active ingredient Purpose
Petrolatum 53.4% Skin Protectant
Lanolin 15.5% Skin Protectant
" ], "active_ingredient": [ "Active ingredient Purpose Petrolatum 53.4% Skin Protectant Lanolin 15.5% Skin Protectant" ] }, { "effective_time": "20120501", "inactive_ingredient": [ "INACTIVE INGREDIENTS: COD LIVER OIL (VITAMIN A AND D), FRAGRANCE (PARFUM), LIGHT MINERAL OIL, MICROCRYSTALLINE WAX, PARAFFIN." ], "purpose": [ "PURPOSE SKIN PROTECTANT SKIN PROTECTANT" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER THOROUGHLY. STOP USING THIS PRODUCT AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS. KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER THOROUGHLY." ], "questions": [ "QUESTIONS? CALL 1-800-910-6374." ], "spl_product_data_elements": [ "UP AND UP DIAPER RASH LANOLIN, PETROLATUM LANOLIN LANOLIN PETROLATUM PETROLATUM COD LIVER OIL LIGHT MINERAL OIL MICROCRYSTALLINE WAX PARAFFIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR SKIN PROTECTANT USE APPLY AS NEEDED. FOR DIAPER RASH USE, CHANGE WET AND SOILED DIAPERS PROMPTLY. CLEAN THE DIAPER AREA AND ALLOW TO DRY.APPLY OINTMENT AS OFTEN AS REQUIRED WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS." ], "storage_and_handling": [ "OTHER INFORMATION STORE BETWEEN 20-25C (58-77F)." ], "do_not_use": [ "DO NOT USE ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES HELPS TREAT AND PREVENT DIAPER RASH. TEMPORARILY PROTECTS MINOR CUTS, SCRAPES AND BURNS. TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFED OR CRACKED SKIN AND LIPS. HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER." ], "set_id": "d9dfb089-2bdc-4b0f-926e-9d6068f1e5e6", "id": "89911c15-f5cf-4013-b4da-0fbf0b7383dd", "active_ingredient": [ "ACTIVE INGREDIENTS LANOLIN 15.5% PETROLATUM 53.4% PURPOSE SKIN PROTECTANT SKIN PROTECTANT" ] }, { "effective_time": "20110810", "inactive_ingredient": [ "Inactive ingredients Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Methylparaben, Steareth-2, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum" ], "purpose": [ "Purpose First aid antibiotic First aid antibiotic First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use if you are allergic to any of the ingredients Ask a doctor before use if you have serious burns deep or puncture wounds animal bites When using this product do not use in the eyes do not apply over large areas of the body Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use in the eyes do not apply over large areas of the body" ], "spl_product_data_elements": [ "Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B CETYL ALCOHOL GLYCERIN LIGHT MINERAL OIL STEARETH-2 SQUALANE STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE, D- PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have serious burns deep or puncture wounds animal bites" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age or older: clean the affected area apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if you need to use more than 1 week condition persists or gets worse symptoms persist for more than 1 week or clear up and occur again within a few days. rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 20° - 25° (68° to 77°F)" ], "do_not_use": [ "Do not use if you are allergic to any of the ingredients" ], "package_label_principal_display_panel": [ "Package label panel Triple Antibiotic Ointment Plus Pain Relief image of a carton" ], "indications_and_usage": [ "Uses First aid to help prevent infection in minor: cuts scrapes burns" ], "set_id": "de9a70ee-4dd6-4859-b542-508f7f55745b", "id": "3fe86fd2-a670-48b0-aa77-568be6234120", "active_ingredient": [ "Active ingredient Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units" ] }, { "effective_time": "20150617", "inactive_ingredient": [ "Inactive Ingredients PETROLATUM, LIGHT MINERAL OIL, STEARIC ACID, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHMIDE MEA." ], "purpose": [ "Purpose First Aid Antibiotic Topical Analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use if you are allergic to any of the ingredients in or near the eyes longer than 1 week over large areas of the body Ask a doctor before use on deep or puncture wounds, animal bites or serious burns Stop use and ask a doctor if condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days a rash or other allergic reaction develops." ], "questions": [ "Questions or information call toll free: Call 1-855-ATOPALM" ], "spl_product_data_elements": [ "ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYCIN B SULFATE, PRAMOXINE HCL BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PRAMOXINE HYDROCHLORIDE PRAMOXINE PETROLATUM LIGHT MINERAL OIL CHOLESTEROL STEARIC ACID MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA" ], "ask_doctor": [ "Ask a doctor before use on deep or puncture wounds, animal bites or serious burns" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions Adults and children 2 years of age and older clean the affected area and dry throughly apply a small amount (equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage Children under 2 yrs. of age Consult a doctor." ], "spl_unclassified_section": [ "ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING OINTMENT AND PAIN RELIEF" ], "stop_use": [ "Stop use and ask a doctor if condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days a rash or other allergic reaction develops." ], "storage_and_handling": [ "Other Information store at 68° – 77°F (20° – 25°C) see carton flap or tube crimp for lot number and expiration date" ], "do_not_use": [ "Do not use if you are allergic to any of the ingredients in or near the eyes longer than 1 week over large areas of the body" ], "package_label_principal_display_panel": [ "AtopalmMoisturizingFirstAidTripleAntibioticProtection AtopalmMoisturizingFirstAidTripleAntibioticProtectionInner" ], "indications_and_usage": [ "Uses First aid to help prevent infection and for the temporary relief of pain and discomfort of minor cuts, scrapes, burns." ], "set_id": "deaa865f-ec8f-42eb-ac34-fde9985f1391", "id": "be45bc4b-d94b-4a85-9fa2-5cb7d1880a76", "active_ingredient": [ "Active Ingredients (each gram contains) Bacitracin Zinc 500 units Neomycin Sulfate 3.5mg Polymycin B Sulfate 10,000 units Pramoxine HCl 10mg" ] }, { "effective_time": "20131205", "inactive_ingredient": [ "Inactive ingredients Cetyl alcohol, Light Mineral Oil, Methylparaben, Propylparaben, Squalane, Tocopheryl acetate, White petrolatum" ], "purpose": [ "Purposes First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than one week unless directed by a doctor Consult a doctor in case of deep or puncture woundsanimal bitesserious burns Stop use and ask a doctor if the condition persists or gets worsea rash or other allergic reaction occurs Keep out of reach of children In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately." ], "when_using": [ "Consult a doctor in case of deep or puncture woundsanimal bitesserious burns" ], "spl_product_data_elements": [ "Antibiotic Neomycin sulfate NEOMYCIN SULFATE NEOMYCIN CETYL ALCOHOL SQUALANE LIGHT MINERAL OIL PETROLATUM .ALPHA.-TOCOPHEROL ACETATE, D- METHYLPARABEN PROPYLPARABEN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age and older: clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finer) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if the condition persists or gets worsea rash or other allergic reaction occurs" ], "storage_and_handling": [ "Other information store at room temperature" ], "do_not_use": [ "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than one week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Package label Antibiotic Ointment image of caton label" ], "indications_and_usage": [ "Uses First aid to help prevent infection in minor: cuts scrapes burns" ], "set_id": "e1561623-c792-4cb9-bfc1-6d37d1f4bf66", "id": "3c0ddae5-1273-482b-8fa8-f8b88a99a956", "active_ingredient": [ "Active ingredient (in each gram) Neomycin 3.5mg" ] }, { "effective_time": "20100716", "inactive_ingredient": [ "Inactive Ingredients acetone sodium bisulfite, lanolin, light mineral oil, purified water, white petrolatum" ], "purpose": [ "Active ingredients Purpose Dibucaine 1%...............................................Hemorrhoidal/Local analgesic ointment Use s temporarily relieves pain and itching due to: - hemorrhoids or other anorectal disorders - sunburn - minor burns - minor cuts - scrapes - insect bites - minor skin irritation" ], "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. Allergy alert - certain persons san develop allergic reactions to ingredients in this product Do not use - in or near the eyes - do not get into the eyes - in infants under 2 years of age - in large quantities, particularly over raw surfaces or blistered areas - do not put this product into rectum by using fingers or any mechanical device Stop use and ask a doctor if - condition worsens, or does not improve within 7 days - the symptom being treated does not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase If pregnant or breast feeding, as a health care 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": [ "DIBUCAINE DIBUCAINE LANOLIN ACETONE SODIUM BISULFITE PETROLATUM WATER MINERAL OIL DIBUCAINE DIBUCAINE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions - if possible clean the affected area with mild soap and warm water and rinse thoroughly - gently dry by patting or blotting with toilet tissue or a soft cloth before applying Adults and children 12 and over - apply externally to the affected area up to 3 to 4 times a day. Children under 2 - 12 years of age - ask a doctor Infants under 2 years of age - DO NOT USE" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Use s temporarily relieves pain and itching due to: - hemorrhoids or other anorectal disorders - sunburn - minor burns - minor cuts - scrapes - insect bites - minor skin irritation Other information - to secure child resistant cap; screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure. - see crimp of tube for lot number and expiration date -store at controlled room temperature 20 degrees to 25 degrees c (68 degrees to 77 degrees F)" ], "set_id": "e3807a1b-c375-456a-bd7e-de3a1607c8fc", "id": "d7142db6-14d7-43ab-b0dd-64459a2be200", "active_ingredient": [ "Active ingredients Purpose Dibucaine 1%...............................................Hemorrhoidal/Local analgesic ointment" ] }, { "effective_time": "20140506", "inactive_ingredient": [ "Inactive ingredients Light Mineral Oil, White Petrolatum" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away" ], "purpose": [ "Purpose First aid to help prevent infection in: Minor cuts scrapes burns" ], "warnings": [ "Warnings: For external use only Dosage and Administration: clean the affected areas apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily may be covered with a sterile bandage Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use: if you are allergic to any of the ingredients in the eyes over large areas of the body longer than 1 week unless directed by a doctor Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away" ], "spl_product_data_elements": [ "Bacitracin Bacitracin MINERAL OIL PETROLATUM BACITRACIN BACITRACIN" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Dosage and Administration: clean the affected areas apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops." ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30° C (59°-86° F)" ], "do_not_use": [ "Do not use: if you are allergic to any of the ingredients in the eyes over large areas of the body longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel Bacitracin Ointment: bacitracin-galentic-ointment-01.jpg 1162_1163_Bacitracin_Ointment" ], "indications_and_usage": [ "Indications and Usage Ask a doctor before use: in case of deep or puncture wounds animal bites serious burns" ], "set_id": "e8e4f5e5-0506-4a68-b9b7-19c48b9ae053", "id": "eb0099e9-bf25-48df-b434-17eb039c31da", "active_ingredient": [ "Active ingredient Purpose Bacitracin 500 Units Antibiotic" ] }, { "effective_time": "20130601", "inactive_ingredient": [ "PARAFFIN BUTYLATED HYDROXYTOLUENE METHYLPARABEN PROPYLPARABEN CHLOROCRESOL LANOLIN MAGNESIUM STEARATE LIGHT MINERAL OIL" ], "purpose": [ "Protectant Vasoconstrictor" ], "keep_out_of_reach_of_children": [ "If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external and/or intrarectal use only" ], "spl_product_data_elements": [ "APJ HEMORRHOIDAL PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PETROLATUM PETROLATUM MINERAL OIL MINERAL OIL PARAFFIN BUTYLATED HYDROXYTOLUENE METHYLPARABEN PROPYLPARABEN CHLOROCRESOL LANOLIN MAGNESIUM STEARATE LIGHT MINERAL OIL OFF WHITE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "■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" ], "package_label_principal_display_panel": [ "DISPLAY PANEL product" ], "indications_and_usage": [ "■ 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": "e971a664-c814-4c8a-96ab-7fdaa974335d", "id": "a0c485a4-d719-42e7-8764-459756dfdae3", "active_ingredient": [ "PHENYLEPHRINE HYDROCHLORIDE PETROLATUM MINERAL OIL" ] }, { "effective_time": "20130625", "inactive_ingredient": [ "Inactive Ingredient Water, Light mineral oil, Petrolatum, Peg 100 stearate, Propylene Glycol, Oleth 5, Glycerin, cetyl Alcohol, DMDM Hydantoin, Magnesium Aluminum silicate, Methyl and propyl paraben, Guarcel" ], "purpose": [ "Uses For mosturizing and softening dry scaly skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In the event of accidental ingestion contact a posion control center right away." ], "warnings": [ "FOR EXTERNAL USE ONLY When using this product Avoid contact with eyes, lips or mucous membranes Do not apply over deep or punctured wounds, infections or lacerations. Cautions: Irritation may occur on the face. Fair skinned individuals may experience mild stinging. Burning or peeling may occur on sensitive or irritated skin areas. If irritation occurs, Discontinue use immediately and consult a physcian for appropiate therapy." ], "spl_product_data_elements": [ "Geri-Hydrolac Ammonium Lactate AMMONIUM LACTATE LACTIC ACID WATER MINERAL OIL PETROLATUM PEG-100 STEARATE PROPYLENE GLYCOL LAURETH-4 GLYCERIN CETYL ALCOHOL DMDM HYDANTOIN MAGNESIUM ALUMINUM SILICATE METHYLPARABEN PROPYLPARABEN GUAR GUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Twice daily or as directed by a physician" ], "storage_and_handling": [ "Store at room temperature (59'-86'F)" ], "package_label_principal_display_panel": [ "label of Tube" ], "indications_and_usage": [ "Directions Apply to affected areas and rub in thoroughly, twice daily or as directed by a physician" ], "set_id": "f1be69b8-8cfd-428c-aa79-eeb87e3cd3e3", "id": "d54e551d-9f7e-4e48-8068-c9e642a168d6", "active_ingredient": [ "Drug Facts Active Ingredient: Ammonium lactate 12% Purpose: Stimulates cell renewal for improved skin condition" ] }, { "effective_time": "20131210", "inactive_ingredient": [ "Inactive ingredients light mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of accidental Ingestion, seek professional assistance or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients Ask a doctor before use if you have deep or puncture wounds animal bites When using this product do not use longer than 1 week unless directed by a doctor Stop use and ask a doctor if condition persists or gets worse a rash or other allergic reaction develops Keep out of reach of children In case of accidental Ingestion, seek professional assistance or contact a Poison Control Center immediately." ], "when_using": [ "When using this product do not use longer than 1 week unless directed by a doctor" ], "spl_product_data_elements": [ "Bacitracin Zinc Bacitracin Zinc MINERAL OIL PETROLATUM BACITRACIN ZINC BACITRACIN" ], "ask_doctor": [ "Ask a doctor before use if you have deep or puncture wounds animal bites" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if condition persists or gets worse a rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 20 - 25C (68 - 77F)" ], "do_not_use": [ "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients" ], "package_label_principal_display_panel": [ "Package label image of carton label" ], "indications_and_usage": [ "Uses First aid to help prevent infection in minor: cuts scrapes burns" ], "set_id": "f1f7ba23-6a90-4eaa-8eeb-d73db774b863", "id": "f1eac575-6602-4a06-a863-647497d835f0", "active_ingredient": [ "Active ingredient (in each gram) Bacitracin Zinc 500 units" ] }, { "effective_time": "20130211", "purpose": [ "Active ingredients (in each tablet) Purposes Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-570-8650" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "Other information store at controlled room temperature 20°-25°C (68°-77°F) read all product information before using. Keep this box for important information." ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps" ], "set_id": "f1fe57c7-a7ea-450d-b9b9-39d512b31d79", "id": "a4c899e8-155f-4dd0-a8a5-002aba7230d6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition" ], "active_ingredient": [ "Active ingredients (in each tablet) Purposes Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid" ], "inactive_ingredient": [ "Inactive ingredients benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide" ], "warnings": [ "Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning This product contains acetaminophen. Severe liver damage may occur if you take adult takes more than 8 tablets in 24 hours, which is the maximum daily amount child takes more than 5 tablets in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have not been drinking fluids you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have lost a lot of fluids due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. 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": [ "ConRx pain Reliever Acetaminophen, Aspirin, and Caffeine Acetaminophen Acetaminophen Aspirin Aspirin Caffeine Caffeine CARNAUBA WAX BENZOIC ACID HYDROXYPROPYL CELLULOSE (TYPE H) FD&C BLUE NO. 1 HYPROMELLOSES LIGHT MINERAL OIL CELLULOSE, MICROCRYSTALLINE POLYSORBATE 20 POVIDONES POLYETHYLENE GLYCOL 6000 DIMETHICONE SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE CRX" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have not been drinking fluids you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have lost a lot of fluids due to vomiting or diarrhea" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purposes
Acetaminophen 250 mg Pain reliever
Aspirin 250 mg (NSAID)nonsteroidal anti-inflammatory drug Pain reliever
Caffeine 65 mg Pain reliever aid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 50 Pouch Box See New Warnings Information & Directions Compare to the Active Ingredients in EXCERDRIN* ® ConRx™ EXTRA STRENGTH PAIN RELIEVER Acetaminophen, Asprin (NSAID) and Caffeine TO OPEN PUSH IN TAB AND PULL OUT Compare to the Active Ingredients in EXCEDRIN* ® 50 Pouches of 2 Caplets Each Principal Display Panel - 50 Pouch Box" ], "purpose_table": [ "
Active ingredients (in each tablet) Purposes
Acetaminophen 250 mg Pain reliever
Aspirin 250 mg (NSAID)nonsteroidal anti-inflammatory drug Pain reliever
Caffeine 65 mg Pain reliever aid
" ] }, { "effective_time": "20111116", "inactive_ingredient": [ "Inactive Ingredients Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum" ], "purpose": [ "Purpose Antibacterial / Skin Protectant" ], "keep_out_of_reach_of_children": [ "- Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately." ], "warnings": [ "Warnings - Do not use over deep or puncture wounds, infections, or lacerations. Do not apply over large areas of the body . - When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. For external use only. - Stop use and ask a doctor if condition worsens or does not improve in 7 days.." ], "spl_product_data_elements": [ "Rash Relief Antibacterial Bacitracin Dimethicone Zinc Oxide Bacitracin Bacitracin Dimethicone Dimethicone Zinc Oxide Zinc Oxide Cyclomethicone Mineral Oil Lanolin Microcrystalline Wax Hexamethyldisiloxane Water Cholecalciferol Vitamin a palmitate Petrolatum" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - Cleanse the skin area, and allow to dry. - Shake bottle well before use. - Spray 4-6 inches from skin. No rub-in is required. - Apply liberally as often as necessary to soothe and protect irritated skin." ], "package_label_principal_display_panel": [ "Enter section text here RRABSPRAY" ], "indications_and_usage": [ "Uses: First aid to help prevent infection in minor cuts, scrapes, and burns. Treats and prevents minor skin irritation: itching, diaper rash, feeding tube sites, cuts, and minor burns." ], "set_id": "f439fb97-0722-42ee-bc90-67daf0497aa8", "id": "24e155fd-dad7-4d37-a12d-0c18fc624481", "active_ingredient": [ "Active Ingredients Bacitracin 500 units/g Dimethicone 20% Petrolatum 25%" ] }, { "effective_time": "20140314", "inactive_ingredient": [ "Inactive ingredients light mineral oil, peppermint oil, purified water, saccharin sodium" ], "purpose": [ "Purpose Saline laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings" ], "questions": [ "Questions? 1-800-560-5223 Monday-Friday 9 AM - 4 PM EST" ], "spl_product_data_elements": [ "Magmex Magnesium hydroxide MAGNESIUM HYDROXIDE MAGNESIUM CATION MINERAL OIL PEPPERMINT OIL SODIUM HYPOCHLORITE SACCHARIN SODIUM SPEARMINT WATER" ], "ask_doctor": [ "Ask a doctor before use if you have •kidney disease •a magnesium-restricted diet •stomach pain, nausea, or vomiting •a sudden change in bowel habits that lasts more than 2 weeks" ], "other_safety_information": [ "Other information •each tablespoon (15 mL) contains: calcium 20 mg, magnesium 595 mg, and sodium 2 mg •does not meet USP requirements for preservative effectiveness •store at 20-25oC (68-77oF) •keep tightly closed •avoid freezing" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions •shake well before use •do not exceed the maximum recommended daily dose in a 24 hour period •dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor •drink a full glass (8 oz) of liquid with each dose•for accurate dosing, use dose cup provided •TBSP = tablespoonful adults and children 12 years and older 2 to 4 TBSP. children 6 to 11 years 1 to 2 TBSP. children under 6 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if •you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. •you need to use a laxative for more than 1 week" ], "package_label_principal_display_panel": [ "Magmex Label" ], "indications_and_usage": [ "Uses •relieves occasional constipation (irregularity) •generally produces bowel movement in ½ to 6 hours" ], "set_id": "f9fb93da-67e8-4745-a8b3-bebfe6fdda5c", "id": "4d97128d-74b9-43ec-b70e-6f73787d5b19", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (in each 15 mL TBSP) Magnesium hydroxide 1200 mg" ] }, { "effective_time": "20130409", "inactive_ingredient": [ "Inactive ingredients light mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings For external use only. Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "fulton street market triple antibiotic original strength bacitracin, neomycin, polymyxin B BACITRACIN BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM LIGHT MINERAL OIL Translucent" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body" ], "package_label_principal_display_panel": [ "Principal Display Panel original strength triple antibiotic ointment bacitracin, neomycin sulfate, polymyxin b sulfate first aid antibiotic ointment Triple Antibiotic Ointment Carton Image" ], "indications_and_usage": [ "Uses first aid to help prevent infection in minor: • cuts • scrapes • burns" ], "set_id": "fcf45ba9-2848-4925-ab03-8a262863763c", "id": "9ec1a46a-855d-497e-bfb6-2731dec62a62", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns" ], "active_ingredient": [ "Active ingredient (in each gram) Bacitracin 400 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate" ] }, { "effective_time": "20111213", "inactive_ingredient": [ "Inactive ingredients light mineral oil, white petrolatum" ], "purpose": [ "Purpose First aid antibiotic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Bacitracin Bacitracin BACITRACIN BACITRACIN LIGHT MINERAL OIL PETROLATUM" ], "ask_doctor": [ "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage" ], "stop_use": [ "Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops" ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients" ], "package_label_principal_display_panel": [ "Principal Display Panel Bacitracin 500 Units" ], "indications_and_usage": [ "Uses first aid to help prevent infection in: minor cuts scrapes burns" ], "set_id": "fea57e0a-c472-4c83-9afd-6765a16600b9", "id": "fea57e0a-c472-4c83-9afd-6765a16600b9", "active_ingredient": [ "Active ingredient (each gram contains) Bacitracin 500 units" ] }, { "effective_time": "20110216", "inactive_ingredient": [ "Inactive Ingredients cod liver oil (contains vitamin A and vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin." ], "purpose": [ "Active ingredients Purpose Lanolin 15.5%..>>>>...................................Skin Protectant Petrolatum 53.4%.......................................Skin protectant ______________________________________ Uses - temporarily protects minor: - cuts - scrapes - burns - temporarliy protects and helps relieved chapped, chafed or cracked skin and lips - helps protect from the drying effects of wind and cold weather" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. _______________________________ Do not use on: - Deep or puncture wounds - animal bites - serious burns _______________________________ When using this product - Do not get into eyes. _______________________________ Stop use and ask a doctor if: -condition worsens -symptoms last more than 7 days or clear up and occur again within a few days __________________________________ Keep out of reach of Children. If swallowed, get medical help or contact a Poison Control Center right away" ], "spl_product_data_elements": [ "PETROLATUM, LANOLIN PETROLATUM, LANOLIN PETROLATUM PETROLATUM PARAFFIN MICROCRYSTALLINE WAX MINERAL OIL COD LIVER OIL CARROT SEED OIL LANOLIN LANOLIN" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions - apply as needed ________________________________ Other information Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Uses - temporarily protects minor: - cuts - scrapes - burns - temporarliy protects and helps relieved chapped, chafed or cracked skin and lips - helps protect from the drying effects of wind and cold weather" ], "set_id": "feec81cf-2fb3-4886-99f4-affed0003b74", "id": "8129e947-b93c-4c38-aa55-5a83d3798436", "active_ingredient": [ "Active ingredients Purpose Lanolin 15.5%..>>>>...................................Skin Protectant Petrolatum 53.4%.......................................Skin protectant" ] } ] }