Label: X OUT CLEANSING BODY BAR- salicylic acid soap 

  • 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 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 1%

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  • Purpose

    Acne Treatment

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  • Use

    for the management of acne.

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  • Warnings

    For external use only

    When using this product

    • skin irritation and dryness are 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.
    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    If irritation becomes severe.

    Keep out of reach of children.

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

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  • Directions

    • apply a small amount to dampened skin.
    • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
    • 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 or peeling occurs, reduce application to once a day or every other day.
    • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
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  • Inactive ingredients

    sodium cocoyl isethionate, stearic acid, water, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, polyethylene, disodium EDTA, pentasodium pentetate, titanium dioxide (CI 77891)

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  • Questions or comments?

    Within US 1-800-524-7952

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  • SPL UNCLASSIFIED SECTION

    Dist. by: Guthy-Renker® LLC • PO Box 14383 Palm Desert, CA 92255-4383

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  • PRINCIPAL DISPLAY PANEL - 141 g Applicator Carton

    X®
    OUT

    CLEANSING
    BODY BAR

    From the Makers of Proactiv®

    salicylic acid acne treatment
    5.0 OZ. • 141 g

    Principal Display Panel - 141 g Applicator Carton
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  • INGREDIENTS AND APPEARANCE
    X OUT CLEANSING BODY BAR 
    salicylic acid soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11410-007
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 mg  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM COCOYL ISETHIONATE  
    STEARIC ACID  
    WATER  
    SODIUM ISETHIONATE  
    COCAMIDOPROPYL HYDROXYSULTAINE  
    SODIUM CHLORIDE  
    HIGH DENSITY POLYETHYLENE  
    EDETATE DISODIUM  
    PENTASODIUM PENTETATE  
    TITANIUM DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-007-37 1 in 1 CARTON
    1 141 g in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 12/31/2012
    Labeler - Guthy-Renker LLC (608315453)
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