Label: CLEARASIL  DAILY CLEAR VANISHING ACNE TREATMENT- benzoyl peroxide cream 

  • 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 11/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Benzoyl peroxide 10%

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  • Purpose

    Acne medication

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  • Use

    for the treatment of acne

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  • Warnings

    For external use only

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    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 and dryness is 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.
    • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly 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.

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  • 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 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.
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  • Other information

    • keep tightly closed
    • store at 20-25 °C (68-77 °F)
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  • Inactive ingredients

    Water, Propylene Glycol, Aluminium Hydroxide, Bentonite, Glyceryl Stearate SE, PEG-12, Isopropyl Myristate, Methylparaben, Carbomer, Potassium Hydroxide, Propylparaben

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  • Questions?

    Call 1-866-25-CLEAR (1-866-252-5327). You may also report side effects to this phone number.

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Reckitt Benckiser LLC
    Parsippany, NJ 07054-0224
    Made in USA © RB 2011

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  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Clearasil®

    DAILY CLEAR®

    Vanishing Acne
    Treatment Cream

    Benzoyl Peroxide 10% Acne Medication

    Principal Display Panel - 28 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CLEARASIL   DAILY CLEAR VANISHING ACNE TREATMENT
    benzoyl peroxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-303
    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
    Water  
    Propylene Glycol  
    Aluminum Hydroxide  
    Bentonite  
    Glyceryl Stearate SE  
    Polyethylene Glycol 600  
    Isopropyl Myristate  
    Methylparaben  
    Potassium Hydroxide  
    Propylparaben  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-303-02 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 09/01/2011
    Labeler - Reckitt Benckiser LLC (094405024)
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