Label: ACNE TREATMENT- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 17, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients

    Benzoyl peroxide 10%

  • Purpose

    Acne medication

  • Use

    for the treatment of acne

  • Warnings

    For external use only

  • Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide
  • When using this product

    • skin irritation and dryness is more likely to occur if you use aother 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 posible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
  • stop use and ask a doctor if

    irritation becomes severe

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 daily 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
  • inactive ingredients

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

  • Questions 

    1-888-423-0139

  • Disclaimer

    *This product is not manufactured or distributed by Kenvue, Inc., distributor of Clean & Clear® Persa-Gel® 10 Maximum Strength.

  • Adverse Reaction

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    Itasca, IL 60143 ©TOPCO VIJA0424

    QUESTIONS? 1-888-423-0139

    topcare@topco.com

    www.topcarebrand.com

    Quality Guaranteed

    Scan here for more information or call 1-888-423-0139

  • principal display panel

    TopCare® Beauty

    ACNE TREATMENT

    10% Benzoyl Peroxide

    Compare to CLEAN & CLEAR® Persa-Gel® 10*

    Maximum strength benzoyl peroxide acne medication available under the product monograph

    This micronized benzoyl peroxide formula goes to work releasing the medicine deep into the pore where pimples begin.

    Dermatologist Tested

    PARABEN & PHTHALATE FREE

    Fragrance Free

    NET WT 1 OZ (28 g)

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-229
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-229-101 in 1 PACKAGE08/23/2022
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/23/2022
    Labeler - Topco associates LLC (006935977)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(76162-229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fidelitone Order Fulfillment117825116pack(76162-229)