Label: ACNE TREATMENT- benzoyl peroxide gel
- NDC Code(s): 49035-229-10
- Packager: Wal-Mart Stores, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 15, 2024
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- Do not use if you
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When using this product
- skin irritation and dryness is more likely to occur if you use aother topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with eyes, lips and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- skin irritation may occur, characterized by redness, buring, itching, peeling or posible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
- stop use and ask a doctor if
- Keep out of reach of children
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Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor
- inactive ingredients
- Questions?
- Claims
- SPL UNCLASSIFIED SECTION
- principal display panel
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INGREDIENTS AND APPEARANCE
ACNE TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-229 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LAURETH-4 (UNII: 6HQ855798J) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-229-10 1 in 1 CARTON 01/06/2015 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 01/06/2015 Labeler - Wal-Mart Stores, Inc (051957769) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091520 manufacture(49035-229) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(49035-229) Establishment Name Address ID/FEI Business Operations Remar Inc. 117825116 pack(49035-229)
