Label: X-OUT WASH-IN TREATMENT- benzoyl peroxide gel 

  • Label RSS
  • NDC Code(s): 11410-117-48, 11410-117-49
  • Packager: Guthy-Renker LLC
  • 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 08/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Benzoyl Peroxide 8.5%

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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

    Do not use this medication if you

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

    When using this product

    • skin irritation and dryness is 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 expose and use a sunscreen.
    • avoid contact with the eyes, lips and mouth.
    • skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    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

    use morning and night

    • apply to dampened skin and gently massage for 1 to 2 minutes.
    • rinse thoroughly with warm water.
    • pat dry.
    • 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 product and see a doctor.
    • do not use product more than three times a day.
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  • Other information

    • sensitivity test: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
    • avoid contact with hair and dyed fabrics, which may be bleached by this product.
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  • Inactive Ingredients

    water (aqua), sodium cocoyl isethionate, glycerin, polyethylene, lauryl/myristyl benzoate, linoleic acid, linolenic acid, menthol, butylene glycol, dimethicone, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, phenoxyethanol, fragrance (parfum).

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  • SPL UNCLASSIFIED SECTION

    Distributed by Guthy-Renker® LLC, Palm Desert, CA 92260

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  • PRINCIPAL DISPLAY PANEL - 200 g Bottle Label

    X
    OUT

    WASH-IN
    TREATMENT

    benzoyl peroxide acne treatment
    7.0 OZ. • 200 g

    Principal Display Panel - 200 g Bottle Label
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  • INGREDIENTS AND APPEARANCE
    X-OUT WASH-IN TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11410-117
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 8.5 mg  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM COCOYL ISETHIONATE  
    GLYCERIN  
    HIGH DENSITY POLYETHYLENE  
    LINOLEIC ACID  
    LINOLENIC ACID  
    MENTHOL  
    BUTYLENE GLYCOL  
    DIMETHICONE  
    ETHYLHEXYLGLYCERIN  
    SODIUM HYDROXIDE  
    PHENOXYETHANOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-117-48 75 g in 1 BOTTLE
    2 NDC:11410-117-49 200 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 09/23/2011
    Labeler - Guthy-Renker LLC (608315453)
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