Label: MEDPURA BENZOYL PEROXIDE- benzoyl peroxide liquid
- NDC Code(s): 71399-9234-5, 71399-9234-8, 71399-9236-5, 71399-9236-8
- Packager: Akron Pharma Inc.
- 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 March 10, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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
- avoid unnecessary sun exposure and use a sunscreen.
- avoid contact with eyes, lips, and mouth, eyelids and mucous membranes.
- avoid contact with hair or 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.
- 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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Directions
- Shake well
- 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.
- wet area to be cleansed
- apply acne wash and gently massage area for 1-2 minutes
- rinse thoroughly and pat dry
- 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
benzoyl peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-9234 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) ALCOHOL (UNII: 3K9958V90M) METHYL SALICYLATE (UNII: LAV5U5022Y) 2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE (UNII: 59RU860S8D) 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:71399-9234-5 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2021 2 NDC:71399-9234-8 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 11/04/2021 MEDPURA BENZOYL PEROXIDE
benzoyl peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-9236 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) ALCOHOL (UNII: 3K9958V90M) METHYL SALICYLATE (UNII: LAV5U5022Y) 2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE (UNII: 59RU860S8D) 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:71399-9236-5 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2021 2 NDC:71399-9236-8 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 11/04/2021 Labeler - Akron Pharma Inc. (067878881)