Label: PROACTIV RENEWING CLEANSER- benzoyl peroxide gel

  • NDC Code(s): 11410-005-00, 11410-005-01, 11410-005-05, 11410-005-10, view more
    11410-005-20, 11410-005-40, 11410-005-70, 11410-005-75, 11410-005-80
  • Packager: Alchemee, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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

View All Sections
  • 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 useif 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.
    • cover the entire affected area with a thin layer and rinse thoroughlyone 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, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, paraffin, cetyl esters, tridecyl trimellitate, trisodium sulfosuccinate, PEG-12 dimethicone, xanthan gum, imidazolidinyl urea, fragrance, methylparaben, sodium sulfate, propylparaben, sodium PCA, propylene glycol, anthemis nobilis flower extract, phenoxyethanol, sodium hyaluronate

  • 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 - 120 mL CARTON

    proactiv®

    CLEANSE
    1
    RENEWING
    CLEANSER
    4 FL. OZ. (120 mL)

    benzoyl peroxide acne medication

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV RENEWING CLEANSER 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-005
    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)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SORBITOL (UNII: 506T60A25R)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    TRISODIUM SULFOSUCCINATE (UNII: 085WB9L09N)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-005-001 in 1 CARTON03/07/2017
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:11410-005-051 in 1 CARTON03/07/2017
    2120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:11410-005-40120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2011
    4NDC:11410-005-2060 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2019
    5NDC:11410-005-1030 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2011
    6NDC:11410-005-70177 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2011
    7NDC:11410-005-80240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2011
    8NDC:11410-005-011 in 1 CARTON03/07/2017
    810 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:11410-005-751 in 1 CARTON01/01/2020
    9177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00610/21/2011
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    kdc/one Chatsworth, Inc.118542196manufacture(11410-005)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!