Label: CLEARASIL ULTRA RAPID ACTION TREATMENT- salicylic acid 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 11/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Salicylic Acid 2%

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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

    Flammable keep away from extreme heat or open flame

    When using this product

    • Avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water
    • With other topical acne medications, at the same time or immediately following use of this product, may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by your doctor
    • Limit use to the face and neck

    Stop use and ask a doctor if skin or eye irritation develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

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  • Directions

    • Cleanse the skin thoroughly before applying medication
    • 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 2 or 3 applications 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
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  • Other information

    • store in a cool dry place
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  • Inactive ingredients

    Water, Alcohol Denat., Polysorbate 20, Sorbitol, Hydroxyethylcellulose, Glycerin, Sodium Hydroxide, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Menthol, Disodium EDTA

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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

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  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Clearasil®

    ULTRA®

    Rapid Action
    Treatment
    Gel

    Salicylic Acid 2%
    Acne Medication

    4
    HOURS

    Visibly
    reduces
    pimple size
    and redness
    in as little
    as 4 hours

    With Acceladerm®
    Technology

    1 FL. OZ. (28 g)

    Principal Display Panel - 28 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CLEARASIL   ULTRA RAPID ACTION TREATMENT
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-341
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (Salicylic Acid) Salicylic Acid 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Polysorbate 20  
    Sorbitol  
    Glycerin  
    Sodium Hydroxide  
    Helichrysum Italicum Flower  
    Lavandula Stoechas Flowering Top  
    Menthol  
    Edetate Disodium  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-341-01 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 08/01/2011
    Labeler - Reckitt Benckiser LLC (094405024)
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