Label: CLEARASIL ULTRA RAPID ACTION  FACE SCRUB- 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 09/12

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

    • wet face
    • dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
    • cover the entire affected area with a thin layer and rinse thoroughly with warm water one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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

    • keep tightly closed
    • store in a cool, dry place
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  • Inactive ingredients

    water, polyethylene, PPG-15 stearyl ether, glycerin, stearyl alcohol, cetyl betaine, distearyldimonium chloride, sodium lauryl sulfate, cetyl alcohol, alcohol, steareth-21, sodium chloride, behenyl alcohol, synthetic wax, steareth-2, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, xanthan gum, dimethyl palmitamine, lauryl alcohol, mica, isopropyl alcohol, disodium EDTA, BHT, magnesium nitrate, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone, sodium sulfate, ferric ferrocyanide, titanium dioxide, FD&C blue no. 1

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  • Questions?

    Call 1-866-25-CLEAR (1-866-252-5327).

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Reckitt Benckiser LLC
    Parsippany, NJ 07054-0224

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  • PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

    Clearasil®

    ULTRA

    Rapid Action
    Face Scrub
    Salicylic Acid 2% Acne Medication

    12
    HOURS

    Visibly
    clearer
    skin in as
    little as
    12 hours

    5 FL OZ (150 mL)

    PRINCIPAL DISPLAY PANEL - 150 mL Tube Label
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  • INGREDIENTS AND APPEARANCE
    CLEARASIL ULTRA RAPID ACTION   FACE SCRUB
    salicylic acid lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-305
    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  
    high density polyethylene  
    PPG-15 stearyl ether  
    glycerin  
    stearyl alcohol  
    cetyl betaine  
    distearyldimonium chloride  
    sodium lauryl sulfate  
    cetyl alcohol  
    alcohol  
    steareth-21  
    sodium chloride  
    docosanol  
    steareth-2  
    lavandula stoechas flowering top  
    helichrysum italicum flower  
    xanthan gum  
    dimethyl palmitamine  
    lauryl alcohol  
    mica  
    isopropyl alcohol  
    edetate disodium  
    butylated hydroxytoluene  
    magnesium nitrate  
    methylchloroisothiazolinone  
    magnesium chloride  
    methylisothiazolinone  
    sodium sulfate  
    ferric ferrocyanide  
    titanium dioxide  
    FD&C blue no. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-305-65 150 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 09/25/2012
    Labeler - Reckitt Benckiser LLC (094405024)
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