Label: CLEARASIL  ULTRA OVERNIGHT WASH- salicylic acid solution 

  • 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 10/12

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

    When using this product

    • avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
    • 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.
    • limit use to the face and neck

    Keep out of reach of children.

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

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  • Directions

    • use as part of your night time regimen
    • wet face
    • dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
    • rinse thoroughly with warm water and pat dry
    • 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 occurs, reduce application to once a day or every other day
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  • Other information

    • store in a cool, dry place
    • do not store in direct sunlight
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  • Inactive ingredients

    water, glycerin, sodium laureth sulfate, coco-glucoside, cocamidopropyl betaine, glycol distearate, PEG-200 hydrogenated glyceryl palmate, laureth-4, sodium chloride, PEG-7 glyceryl cocoate, polyquaternium-43, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, sodium hydroxide, formic acid, phenoxyethanol, sodium benzoate, D&C red no. 33, FD&C blue no. 1

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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 France

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  • PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

    Clearasil®

    ULTRA®

    Overnight
    Wash

    Salicylic Acid 2% Acne Medication

    Helps
    visibly reduce
    pimple size
    and redness
    overnight

    6.78 FL. OZ. (200 mL)

    071511

    0349405

    Principal Display Panel - 200 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    CLEARASIL   ULTRA OVERNIGHT WASH
    salicylic acid solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-306
    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  
    glycerin  
    sodium laureth sulfate  
    coco glucoside  
    cocamidopropyl betaine  
    glycol distearate  
    laureth-4  
    sodium chloride  
    PEG-7 glyceryl cocoate  
    helichrysum italicum flower  
    sodium hydroxide  
    formic acid  
    phenoxyethanol  
    sodium benzoate  
    D&C red no. 33  
    FD&C blue no. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-306-88 200 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 09/28/2012
    Labeler - Reckitt Benckiser LLC (094405024)
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