Label: PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR- benzoyl peroxide lotion 

  • Label RSS
  • NDC Code(s): 11410-011-22, 11410-011-68
  • 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Benzoyl peroxide 2.5%

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  • Purpose

    Acne treatment gel

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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 unnecessary sun exposure and use a sunscreen.
    • avoid contact with the eyes, lips, and mouth.
    • avoid contact with hair and dyed fabrics, which may be bleached by this product.
    • ski 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.

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  • Directions

    • apply a small amount to dampened skin and gently massage for 1 to 2 minutes
    • 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.
    • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
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  • Inactive ingredients

    water, sodium cocoyl isethionate, glycerin, polyethylene, lauryl/myristyl benzoate, linoleic acid, linolenic acid, butylene glycol, dimethicone, ehtylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, glycolic acid, sodium hydroxide, phenoxyethanol, fragrance.

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  • Questions or comments?

    Within US 1-800-950-4695

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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 - 60 mL Tube Carton

    Rodan & Fields
    proactiv+

    Skin
    Smoothing
    Exfoliator

    2 FL. OZ. 60 mL

    benzoyl peroxide
    acne treatment

    Principal Display Panel - 60 mL Tube Carton
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  • INGREDIENTS AND APPEARANCE
    PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR 
    benzoyl peroxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11410-011
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM COCOYL ISETHIONATE  
    GLYCERIN  
    HIGH DENSITY POLYETHYLENE  
    LAURYL/MYRISTYL BENZOATE  
    LINOLEIC ACID  
    LINOLENIC ACID  
    BUTYLENE GLYCOL  
    DIMETHICONE  
    ETHYLHEXYLGLYCERIN  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    GLYCOLIC ACID  
    SODIUM HYDROXIDE  
    PHENOXYETHANOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-011-68 1 in 1 BOX
    1 177.4 mL in 1 TUBE
    2 NDC:11410-011-22 1 in 1 BOX
    2 60 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 01/25/2013
    Labeler - Guthy-Renker LLC (608315453)
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