Label: PROACTIV PLUS PORE TARGETING TREATMENT - benzoyl peroxide gel

  • NDC Code(s): 11410-009-12, 11410-009-23, 11410-009-89
  • Packager: THE PROACTIV COMPANY LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 21, 2017

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

    • 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 the 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.

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  • 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.
    • cleanse the skin thoroughly before applying this product.
    • cover the entire affected area with a thin layer 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.
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  • Inactive ingredients

    water, ethoxydiglycol, glycerin, prunus amygdalus dulcis (sweet almond) oil, polysorbate 80, polysorbate 60, sorbitan stearate, carbomer, potassium hydroxide, disodium EDTA, fragrance

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  • Questions or comments?

    Within US 1-800-950-4695

    Distributed by The Proactiv Company LLC
    100 N Sepulveda Blvd., El Segundo, CA 90245
    proactiv.com
    Made in the USA of Foreign and Domestic Components

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  • SPL UNCLASSIFIED SECTION

    Distributed by The Proactiv Company LLC
    100 N Sepulveda Blvd., El Segundo, CA 90245
    Manufactured in Canada ‚óŹ proactiv.com

    Proactiv+ is a trademark of the Proactiv Company Sàrl

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  • PRINCIPAL DISPLAY PANEL - 30 mL

    proactiv+
    Pore Targeting Treatment
    1 FL OZ  30 mL
    benzoyl peroxide acne treatment

    30_ ML_Carton_image_USA
    30_ML_carton_image_canada
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  • PRINCIPAL DISPLAY PANEL - 89 mL

    proactiv+
    Pore Targeting Treatment
    3 FL OZ  89 mL
    benzoyl peroxide acne treatment

    89_ML_CARTON_IMAGE_USA
    89_Ml_CARTON_IMAGE_CANADA
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  • INGREDIENTS AND APPEARANCE
    PROACTIV PLUS PORE TARGETING TREATMENT  
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-009
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Glycerin (UNII: PDC6A3C0OX)  
    Almond Oil (UNII: 66YXD4DKO9)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-009-89 1 in 1 BOX 01/03/2013
    1 89 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2 NDC:11410-009-12 1 in 1 BOX 01/03/2013
    2 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3 NDC:11410-009-23 1 in 1 BOX 01/03/2013
    3 60 mL in 1 BOTTLE, PUMP; 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 01/03/2013
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Establishment
    Name Address ID/FEI Business Operations
    VEE PAK, LLC 874763303 manufacture(11410-009)
    Establishment
    Name Address ID/FEI Business Operations
    KIK Holdco Company Inc 243547333 manufacture(11410-009)
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