Label: GNP ACNE TREATMENT - benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/13

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

    Benzoyl Peroxide 10%.................................................Acne Medication

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  • PURPOSE

    Uses

    • for the treatment and prevention of acne pimples
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  • WARNINGS

    Warnings

    • for external use only
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  • DO NOT USE

    Do not use if you have sensitive skin or are sensitive to benzoyl peroxide

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  • WHEN USING

    When using this product

    • avoid contact with the eyes, lips and mouth
    • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
    • with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor
    • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or concentration may aggravate skin irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
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  • STOP USE

    Stop use and ask a doctor if skin irritation becomes severe

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

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  • INDICATIONS & USAGE

    Directions

    • cleanse the skin thoroughly before applying medication
    • cover the entire affected area with a thin layer one to three times a day
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as direction by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • use to prevent new pimples from forming
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  • STORAGE AND HANDLING

    Other information

    • keep tightly closed
    • keep away from heat
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  • INACTIVE INGREDIENT

    Inactive ingredients liquid paraffin, white petrolatum, cetanol, propylene glycol, stearyl alcohol, polyoxyehylencetylether, sorbitanmonostearate, polysorbate 60, methylparaben, butyl paraben, purified water

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  • DOSAGE & ADMINISTRATION

    Distributed by

    Amerisource Bergen

    1300 Morris Drive

    Chesterbrook, PA 19087

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    GNP ACNE TREATMENT  
    benzoyl peroxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46122-044
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL  
    PETROLATUM  
    PROPYLENE GLYCOL  
    STEARYL ALCOHOL  
    POLYSORBATE 60  
    METHYLPARABEN  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46122-044-03 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 06/30/2013
    Labeler - Amerisource Bergen (007914906)
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