Label: PROACTIV PLUS PORE TARGETING TREATMENT- benzoyl peroxide gel

  • NDC Code(s): 11410-046-00, 11410-046-05, 11410-046-10, 11410-046-15, view more
    11410-046-20, 11410-046-25
  • Packager: Alchemee, 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 11, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl peroxide 2.5%

  • Purpose

    Acne treatment

  • Use

    for the management of acne                 

  • Warnings

    For external use only

    When using this product

    • skin irritation and dryness is 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.

  • 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.
    • clean 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.
  • Inactive ingredients

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

  • Questions or comments?

    1-800-950-4695

  • SPL UNCLASSIFIED SECTION

    Distributed by Alchemee LLC
    Santa Monica, CA 90401
    Made in the USA of Foreign and
    Domestic Components
    Questions? 1-800-950-4695 • proactiv.com

    Proactiv is a registered trademark of
    Taro Pharmaceuticals U.S.A., Inc.

  • PRINCIPAL DISPLAY PANEL - 30 mL

    proactiv+

    Pore
    Targeting
    Treatment

    1 FL. OZ.  (30 mL)
    benzoyl peroxide
    acne treatment

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV PLUS PORE TARGETING TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-046-051 in 1 BOX01/03/2013
    189 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:11410-046-001 in 1 BOX01/03/2013
    230 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:11410-046-151 in 1 CARTON08/01/2018
    389 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:11410-046-101 in 1 CARTON08/01/2020
    410 mL in 1 TUBE; Type 0: Not a Combination Product
    5NDC:11410-046-201 in 1 CARTON12/01/2020
    530 mL in 1 TUBE; Type 0: Not a Combination Product
    6NDC:11410-046-2589 mL in 1 TUBE; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D01/03/2013
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-046)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International Mfg LLC079110793manufacture(11410-046)
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