Label: ACNE MEDICATION 5- benzoyl peroxide lotion 

  • 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

    Active Ingredient

    5% benzoyl peroxide

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  • Uses

    Uses

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

    Warnings

    For external use only

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  • Do not use if you

    Do not use

    if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

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  • Stop use and ask a doctor

    Stop use and ask a doctor if irritation becomes severe and continues.

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  • Keep out of reach of children

    Keep out of reach of children.

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

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  • Directions

    Directions

    • shake well before use
    • 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 use sunscreen after using this product. If irritation or sensitivity develops, discontinue use of both products and consult 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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  • Other information

    Other Information

    to prevent bleaching, avoid contact with hair or dyed fabric and clothing

    KEEP TIGHTLY CLOSE

    store at room temperature 15°-30°C (59°-86°F)

    Lot number and expiration date: See box or bottle

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  • When using this product

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin.  If this occurs, only one drug should be used unless directed by a doctor.
    • irritation may develop, such as redness, burning, itching,peeling, or possibly swelling
    • more frequent use or higher concentrations may aggravate such irritation
    • mild irritation may be reduced by using the product less frequently or in lower concentration
    • keep away from eyes, lips, mouth
    • IT MAY BLEACH HAIR OR DYED FABRICS
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  • Inactive ingredients

    Inactive Ingredients

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

    Distributed by:

    RUGBY LABORATORIES
    LIVONIA, MI 48150 USA

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  • Principal Display Panel

    PRINCIPAL DISPLAY PANEL 8OZ BOTTLE LABEL

    NDC 0536-0810-95
    BENZOYL PEROXIDE 5%
    Clear Up Acne Pimples

    FOR TOPICAL USE

    Net Weight 1 fl oz

    Acne Medication 5% Lotion







     


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  • Purpose

     Acne treatment

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  • Questions?

     Call 1-(800) 645-2158

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  • INGREDIENTS AND APPEARANCE
    ACNE MEDICATION 5 
    benzoyl peroxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-0810
    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 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    STEARETH-30  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    DIISOPROPANOLAMINE  
    EDETATE DISODIUM  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-0810-95 30 mL in 1 BOTTLE, PLASTIC
    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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