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

Drug Label Information

Updated December 4, 2023

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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 notuse 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 peroxide acne 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 DrugM00611/01/2011
    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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