X OUT CLEANSING BODY BAR (SALICYLIC ACID) SOAP [THE PROACTIV COMPANY LLC]

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  • X OUT CLEANSING BODY BAR (SALICYLIC ACID) SOAP [THE PROACTIV COMPANY LLC]

X OUT CLEANSING BODY BAR (SALICYLIC ACID) SOAP [THE PROACTIV COMPANY LLC]
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NDC 11410-007-37
Set ID 0fca4d77-c463-4d35-a518-1e3b2be81a70
Category HUMAN OTC DRUG LABEL
Packager THE PROACTIV COMPANY LLC
Generic Name
Product Class
Product Number
Application Number PART333D
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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-007-371 in 1 CARTON12/31/2012
    1141 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/31/2012
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bradford Soap Works001201045manufacture(11410-007)
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