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X-Out Wash-In Treatment (Guthy-Renker LLC)

Available Formats

Dosage Form Package Information Links
GEL 200 g in 1 BOTTLE (11410-117-49) Label Information
GEL 75 g in 1 BOTTLE (11410-117-48) Label Information

Complete X-Out Wash-In Treatment Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredient

    Benzoyl Peroxide 8.5%


  • Purpose

    Acne treatment gel


  • Use

    For the management of acne


  • Warnings

    For external use only

    • have very sensitive skin.
    • are sensitive to benzoyl peroxide.

    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 unnecessary sun exposure and use a sunscreen.
    • avoid contact with eyes, lips, and mouth.
    • avoid contact with hair and dyed fabrics, which may be bleached by this product.
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration.

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    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 below.
    • 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.
    • if going outside, apply sunscreen after using this product.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

  • Inactive Ingredients

    Water, Sodium Cocoyl Isethionate, Glycerin, Paraffin, Lauryl/Myristyl Benzoate, Coconut Acid, Linoleic Acid, Linolenic Acid, Menthol, Sodium Isethionate, Butylene Glycol, Dimethicone, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Phenoxyethanol, Fragrance

    Questions or comments?
    Within US 1-800-524-7952

    Distributed by The Proactiv Company, LLC.
    100 N Sepulveda Blvd., El Segundo, CA 90245
    XOut.com ● Made in the USE of foreign and domestic components.
    X Out is a trademark of The Proactiv Company Sàrl.


  • PRINCIPAL DISPLAY PANEL - 75 g Bottle Label

    X
    OUT

    WASH-IN
    TREATMENT

    From the Makers of Proactiv®

    benzoyl peroxide acne treatment
     2.5 OZ.  75 g

    X Out Wash-in Treatment Label

  • INGREDIENTS AND APPEARANCE
    X-OUT WASH-IN TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-117
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 8.5 mg  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    MENTHOL (UNII: L7T10EIP3A)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Lauryl/myristyl Benzoate (UNII: N5RS934G6D)  
    Coconut Acid (UNII: 40U37V505D)  
    Sodium Isethionate (UNII: 3R36J71C17)  
    Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) (UNII: 132584PQMO)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-117-48 75 g in 1 BOTTLE; Type 0: Not a Combination Product 09/23/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 09/23/2011
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Establishment
    Name Address ID/FEI Business Operations
    VEE PAK, LLC 874763303 manufacture(11410-117)