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X Out Cleansing Body Bar (Guthy-Renker LLC)

Available Formats

Dosage Form Package Information Links
SOAP 1 APPLICATOR in 1 CARTON (11410-007-37) > 141 g in 1 APPLICATOR Label Information

Complete X Out Cleansing Body Bar Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Salicylic Acid 1%


  • Purpose

    Acne Treatment


  • Use

    for the management of acne                 


  • Warnings

    For external use only

    When using this product
    • do not use this product more than three times per day.
    • 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.


  • Directions

    • 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.
    • 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.

  • Inactive ingredients

    sodium cocoyl isethionate, stearic acid, water, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, disodium EDTA, pentasodium pentetate, titanium dioxide


  • Questions or comments?

    Within US 1-800-524-7952


  • SPL UNCLASSIFIED SECTION

    Distributed by The Proactiv Company LLC ● 100 N Sepulveda Blvd., El Segundo, CA 90245
    XOut.com ● Made in the USA of Foreign and Domestic Components. XOut is a trademark of The Proactiv Company Sàrl.


  • 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

    Proactiv XOut Cleansing Body Bar Carton

  • INGREDIENTS AND APPEARANCE
    X OUT CLEANSING BODY BAR 
    salicylic acid soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-007
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 mg  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Galactoarabinan (UNII: SL4SX1O487)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-007-37 1 in 1 CARTON 12/31/2012
    1 141 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 12/31/2012
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Establishment
    Name Address ID/FEI Business Operations
    Bradford Soap Works 001201045 manufacture(11410-007)