Label: BENZOYL PEROXIDE liquid
- NDC Code(s): 45802-280-01, 45802-280-34
- Packager: Padagis Israel Pharmaceuticals Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 4, 2021
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- 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
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INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE
benzoyl peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-280 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) IMIDUREA (UNII: M629807ATL) WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) SODIUM HYDROXIDE (UNII: 55X04QC32I) LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-280-01 142 g in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2013 2 NDC:45802-280-34 227 g in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/24/2013 Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
