Label: BENZOYL PEROXIDE gel

  • NDC Code(s): 84339-001-01
  • Packager: Enrich Enterprises Xiamen Limited
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 20, 2024

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  • ACTIVE INGREDIENT

    Benzoyl Peroxide 2.5%

  • PURPOSE

    Acne Treatment

  • INDICATIONS & USAGE

    Use For the treatment of acne.

  • WARNINGS

    - For external use only.

  • DO NOT USE

    Do not use if you

    - Are sensitive to benzoyl peroxide.

  • WHEN USING

    When using this product

    - Avoid unnecessary sun exposure and use an SPF.

    -Avoid contact with the eyes, lips, mouth and hair.

    - Skin irritation, redness, burning, itching or peeling may occur.

    - Only use one topical acne medication at a time as skin irritation and dryness is more likely to occur.

    - Keep out of reach of children.

    -If swallowed get medical help or call poison control center immediately.

  • STOP USE

    - If swallowed get medical help or call poison control center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    - Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    - Clean the skin gently before applying this product.

    - Cover the affected area with a fingertip unit of product once or twice daily.

    - If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

  • INACTIVE INGREDIENT

    Other Ingredients: Water, Propanediol, Glycerin, Carbomer, Sodium Phytate, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    84339-001-01

  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84339-001
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84339-001-011 in 1 BOX05/20/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00605/20/2024
    Labeler - Enrich Enterprises Xiamen Limited (529499545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enrich Enterprises Xiamen Limited529499545manufacture(84339-001)
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