Label: ACNE MEDICATION 10- benzoyl peroxide gel

  • 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 01/13

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  • Active ingredient

    Benzoyl Peroxide 10%

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  • Purpose

    Acne treatment

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  • Uses

    • treats acne
    • dries up acne pimples
    • helps prevent new acne pimples
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  • Warnings

    For external use only

    Do not use

    • if you have sensitive skin or are sensitive to benzoly peroxide

    When using this product

    • apply to affected ares only
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips and mouth
    • this product may bleach hair or dyed fabrics
    • with other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. Only one medication should be used unlee directed by a physician
    • skin irritaion may occur characterized by redness, burning, itching, peeling or possible swelling

    Stop 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 immediately.

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  • Directions

    • clean the skin thoroughly before applying
    • cover the entire affected area with a thin layer 1 to 3 times daily
    • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application ot once a day or every other day.
    • if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.
    • Sensitivity Test for New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
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  • Other information

    • store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F)
    • Lot number & expiration date: See box or crimp of the tube
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  • Inactive ingredients

    Brij 30, carbomer, diisopropanolamine, edetate sodium, Purified water

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  • Principal display panel

    10% Benzoyl Peroxide Gel

    Acne Medication Gel 10

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  • INGREDIENTS AND APPEARANCE
    ACNE MEDICATION 10 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-4092
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    STEARETH-30  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    DIISOPROPANOLAMINE  
    EDETATE DISODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-4092-56 1 in 1 CARTON
    1 42.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 10/29/2012
    Labeler - Rugby Laboratories (191427277)
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