Label: ACNE MEDICATION 5- benzoyl peroxide gel 

  • Label RSS
  • 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

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

  • Active Ingredient

    Benzoyl peroxide 5%

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  • Purpose

    Acne Treatment

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  • Keep out of reach of children

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

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  • Directions

    • Clean the skin thoroughly before applying this product
    • Cover 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
    • Sensitivity Test for a 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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  • Warning

    For external use only

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  • Dosage

    Use twice daily or as directed by Physician.

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  • Inactive Ingredients

    Brij 30, carbomer, diisopropanolamine, disodium edetate, purified water

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  • Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide
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  • Uses

    • treats acne
    • dries up acne pimples
    • helps prevent new acne pimples  
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  • When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the 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 possible swetting. Irritation may be reduced by using the product less frequently or in a lower concentration
    • skin irritation and dryness are 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 
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  • Stop use and ask a doctor

    If irritation becomes severe 

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  • Other information

    Store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F)
    For lot number and expiration date: See box or crimp of tube

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  • Questions or comments?

     Call 1-800-645-2158

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  • Principal display panel

    Acne Medication 5

     

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  • INGREDIENTS AND APPEARANCE
    ACNE MEDICATION 5 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-4089
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    EDETATE SODIUM  
    STEARETH-30  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    DIISOPROPANOLAMINE  
    Product Characteristics
    Color WHITE (Off-White) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-4089-56 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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