Label: BENZOYL PEROXIDE suspension
- NDC Code(s): 72162-2337-2
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 45802-318
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 18, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
When using this product
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- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
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- avoid unnecessary sun exposure and use a sunscreen
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- avoid contact with the eyes, lips, and mouth
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- avoid contact with hair and dyed fabrics, which may be bleached by this product
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- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
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Directions
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- shake well
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- Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
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- wet area to be cleansed
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- apply acne wash and gently massage area for 1-2 minutes
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- rinse thoroughly and pat dry
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- 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
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- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
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- 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 or comments?
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE
benzoyl peroxide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72162-2337(NDC:45802-318) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) IMIDUREA (UNII: M629807ATL) LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H) WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72162-2337-2 142 g in 1 BOTTLE; Type 0: Not a Combination Product 06/18/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 02/20/2013 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(72162-2337) , RELABEL(72162-2337)
