Label: MEDPURA BENZOYL PEROXIDE AQUEOUS BASE, ACNE TREATMENT GEL- benzoyl peroxide gel
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NDC Code(s):
71399-9474-5,
71399-9474-6,
71399-9474-9,
71399-9478-5, view more71399-9478-6, 71399-9478-9
- Packager: Akron Pharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 23, 2026
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Use
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Warnings
For external use only
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
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 the 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
- 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.
- 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 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDPURA BENZOYL PEROXIDE AQUEOUS BASE, ACNE TREATMENT GEL
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-9478 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 DOCUSATE SODIUM (UNII: F05Q2T2JA0) CARBOMER 980 (UNII: 4Q93RCW27E) METHYL SALICYLATE (UNII: LAV5U5022Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71399-9478-5 1 in 1 CARTON 09/13/2024 1 42.5 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71399-9478-6 1 in 1 CARTON 09/13/2024 2 60 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:71399-9478-9 1 in 1 CARTON 09/13/2024 3 90 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 09/13/2024 MEDPURA BENZOYL PEROXIDE AQUEOUS BASE, ACNE TREATMENT GEL
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-9474 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 mL Inactive Ingredients Ingredient Name Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) CARBOMER 980 (UNII: 4Q93RCW27E) METHYL SALICYLATE (UNII: LAV5U5022Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71399-9474-5 1 in 1 CARTON 09/13/2024 1 42.5 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71399-9474-6 1 in 1 CARTON 09/13/2024 2 60 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:71399-9474-9 1 in 1 CARTON 09/13/2024 3 90 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 09/13/2024 Labeler - Akron Pharma Inc. (067878881)
