Label: ACNE TREATMENT- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL

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 August 1, 2022

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  • 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, buring, 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?

    1-800-632-6900

  • SPL UNCLASSIFIED SECTION

    Kroger Acne Medication contains maximum strength benzoyl peroxide.

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

    Maximum strength benzoyl peroxide acne medication available under the product monograph.

    10 % benzoyl peroxide Acne Medication

    Kroger

    Maximum Strength

    DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202

    This product is not manufactured of distributed by Johnson & Johnson Consumer Products Company, distributer of Clean & Clear Persa-Gel 10.

    Our Brands. Our Guarantee. Love it or Your Money Back.

    www.Kroger.com

  • principal display panel

    Compare to Clean & Clear Persa-Gel 10

    10% benzoyl peroxide

    Acne Medication

    Kroger

    Maximum Strength

    NET WT. 1 OZ (28g)

    Compare to Clean & Clear Persa-Gel 10

    10% benzoyl peroxide

    Acne Medication

    Kroger

    Maximum Strength

    Maximum strength benzoyl peroxide acne medication available under the product monograph.

    NET WT. 1 OZ (28g)

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-877
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-877-101 in 1 PACKAGE01/06/2015
    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 finalpart333D01/06/2015
    Labeler - Kroger (006999528)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(30142-877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(30142-877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Remar117825116pack(30142-877)