Label: BENZOYL PEROXIDE gel

  • NDC Code(s): 71800-045-06
  • Packager: Innovida Pharmaeutique Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 25, 2025

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  • Active Ingredient

    Benzoyl peroxide USP 10%

  • Purpose

    Acne treatment

  • Uses

    For the treatment of acne

  • 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 
    • 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.
    • Stop use and consult a doctor if· irritation becomes severe
    • If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • 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

    • keep tightly closed 
    • store at room temperature
  • Inactive Ingredients

    carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

  • Product label

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  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71800-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71800-045-061 in 1 CARTON02/10/2025
    162 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/10/2025
    Labeler - Innovida Pharmaeutique Corporation (080892908)