Label: CLEARASIL ULTRA RAPID ACTION PADS- 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 01/13

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

    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.
    • 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

    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 right away.

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  • Directions

    • clean the skin thoroughly before applying this product
    • wipe a pad over face and neck to cover the entire affected area with a thin layer 1 to 3 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

    • keep jar lid tightly closed
    • store in a cool, dry place but do not freeze
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  • Inactive ingredients

    water, alcohol denat., glycerin, isoceteth-20, sorbitol, sodium hydroxide, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, 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
    MADE IN USA

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  • PRINCIPAL DISPLAY PANEL - 90 Pad Container

    Clearasil®

    ULTRA®

    Rapid Action Pads
    Salicylic Acid 2% Acne Medication

    4
    HOURS

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

    90 Pads 3.58 in2 (23.1 cm2)

    With Acceladerm®
    Technology

    071511

    Principal Display Panel - 90 Pad Container
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  • INGREDIENTS AND APPEARANCE
    CLEARASIL ULTRA   RAPID ACTION PADS
    salicylic acid solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-345
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (Salicylic Acid) Salicylic Acid 0.03 g
    Inactive Ingredients
    Ingredient Name Strength
    water  
    glycerin  
    isoceteth-20  
    sorbitol  
    sodium hydroxide  
    helichrysum italicum flower  
    edetate disodium  
    Product Characteristics
    Color      Score     
    Shape ROUND (Pad) Size 231mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-345-01 90 in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 12/12/2011
    Labeler - Reckitt Benckiser LLC (094405024)
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