Label: CLEARASIL ULTRA  RAPID ACTION TREATMENT- salicylic acid lotion 

  • 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 11/13

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

    When using this product

    • avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
    • using other topical acne medications at the same time or immediately following the 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, chest and back

    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 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 2 or 3 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
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  • Other information

    • store in a cool, dry place
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  • Inactive ingredients

    water, butylene glycol, octyldodecanol, steareth-2, cetyl alcohol, steareth-21, dimethicone, polyacrylamide, glycerin, C13-14 isoparaffin, sodium hydroxide, xanthan gum, magnesium aluminum silicate, laureth-7, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract, titanium dioxide

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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 - 118 mL Tube Label

    NEW

    Clearasil®

    ULTRA

    Rapid Action
    Treatment Lotion

    Face, Chest & Back

    Salicylic Acid 2% Acne Medication

    4
    HRS

    MAXIMUM STRENGTH

    Visibly reduces
    pimple size in
    as fast as
    4 hours

    With Acceladerm® Technology
    4 FL. OZ. (118 mL)

    Principal Display Panel - 118 mL Tube Label
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  • INGREDIENTS AND APPEARANCE
    CLEARASIL ULTRA   RAPID ACTION TREATMENT
    salicylic acid lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-314
    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 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    butylene glycol  
    octyldodecanol  
    cetyl alcohol  
    steareth-21  
    dimethicone  
    glycerin  
    C13-14 isoparaffin  
    sodium hydroxide  
    xanthan gum  
    magnesium aluminum silicate  
    laureth-7  
    Helichrysum Italicum Flower  
    titanium dioxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-314-01 118 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 11/08/2013
    Labeler - Reckitt Benckiser LLC (094405024)
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