Label: 5 ACNE MED- benzoyl peroxide gel
- NDC Code(s): 70707-155-15
- Packager: Face Reality, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 5, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use
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Warnings
For external use only
When using this product
- 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.
- 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, 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
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one or 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 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.
- Other information
- Inactive ingredients
- Questions or Comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
5 ACNE MED
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70707-155 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70707-155-15 1 in 1 CARTON 10/15/2011 08/01/2026 1 44 mL 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 10/15/2011 08/01/2026 Labeler - Face Reality, Inc. (602958071)