Label: PROACTIV CLEAN MINERAL ACNE CLEANSER- sulfur cream

  • NDC Code(s): 11410-453-00, 11410-453-05
  • 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 June 16, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sulfur 3%

  • 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.
    • apply only to areas with acne.
    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Do not use on

    • broken skin
    • large areas of the skin.

    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, follows the directions stated below.
    • cover the entire affected area with a thin layer and rinse thoroughly 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.
  • Inactive ingredients

    water, sodium cocoyl isethionate, coco-glucoside, acrylates copolymer, coconut acid, coconut alcohol, glycereth-18 ethylhexanoate, glycereth-18, behenyl alcohol, titanium dioxide (CI 77891), phenoxyethanol, sodium isethionate, sodium hydroxide, arachidyl alcohol, stearyl alcohol, xanthan gum, ethylhexylglycerin, glycerin, tetrasodium glutamate diacetate, chamomilla recumta (matricaria) flower extract

  • Questions or comments?

    Within US 1-800-950-4695

  • SPL UNCLASSIFIED SECTION

    Distributed by Alchemee LLC. 
    Santa Monica, CA 90401 
    Questions or comments? 
    1-800-950-4695 • proactiv.com 
    Made in the USA of foreign and domestic components. 
    Proactiv is a trademark of Taro Pharmaceuticals U.S.A., Inc.

  • PRINCIPAL DISPLAY PANEL - 6 FL. OZ. (177.4 mL)

    proactivcleanTM                        

    Mineral
    Acne Cleanser


    sulfur acne medication

    Both treats and helps
    prevent breakouts
                    

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV CLEAN MINERAL ACNE CLEANSER 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-453
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Sodium Cocoyl Isethionate (UNII: 518XTE8493)  
    Coco Glucoside (UNII: ICS790225B)  
    Coconut Acid (UNII: 40U37V505D)  
    Coconut Alcohol (UNII: 13F4MW8Y9K)  
    Glycereth-18 Ethylhexanoate (UNII: IWS58C6V2Y)  
    Glycereth-18 (UNII: SA5E43C17C)  
    Docosanol (UNII: 9G1OE216XY)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Isethionate (UNII: 3R36J71C17)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
    Matricaria Chamomilla (UNII: G0R4UBI2ZZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-453-001 in 1 BOX08/15/2022
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11410-453-051 in 1 BOX08/15/2022
    2177.4 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D08/15/2022
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    kdc/one Chatsworth, Inc.118542196manufacture(11410-453)