Label: PROACTIV REPAIRING TREATMENT- benzoyl peroxide gel

  • NDC Code(s): 11410-040-00, 11410-040-05, 11410-040-15, 11410-040-25, view more
    11410-040-30, 11410-040-35, 11410-040-45
  • 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 30, 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
    ▪  skin 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.
    • 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.                    
  • Inactive Ingredients

    water, ethoxydiglycol, cyclopentasiloxane, propylene glycol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ceteareth-20, diazolidinyl urea, carbomer, fragrance, methylparaben,  xanthan gum,  panthenol, allantoin,, sodium hydroxide, propylparaben

    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 - 60 mL Carton proactiv® RepairingTreatment Benzoyl peroxideacne medication Step 3:Repair  Proactiv Solution® 

    2 FL. OZ. (60 mL)

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV REPAIRING TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide2.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-040-0030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2011
    2NDC:11410-040-1560 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2011
    3NDC:11410-040-301 in 1 BOX11/01/2011
    389 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:11410-040-25120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2011
    5NDC:11410-040-3589 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2011
    6NDC:11410-040-051 in 1 BOX03/25/2022
    610 mL in 1 TUBE; Type 0: Not a Combination Product
    7NDC:11410-040-451 in 1 BOX01/01/2021
    760 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D11/01/2011
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-040)
    Establishment
    NameAddressID/FEIBusiness Operations
    kdc/one Chatsworth, Inc.118542196manufacture(11410-040)
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