Label: PROACTIV SKIN PURIFYING MASK- sulfur lotion

  • NDC Code(s): 11410-013-00, 11410-013-02, 11410-013-05, 11410-013-10
  • 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

    Sulfur 6%

  • 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.
    • clean the skin thoroughly before applying this product
    • 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, kaolin, glycereth-26, linoleic acid, cetearyl alcohol, magnesium aluminum silicate, synthetic wax, ceteareth-20, sodium lauroyl sarcosinate, linolenic acid, tocopheryl acetate, melaleuca alternifolia (tea tree) leaf oil, cymbopogon schoenanthus extract, geranium maculatum extract, hydrated silica, ethoxydiglycol, butylene glycol, phenoxyethanol, sodium sulfate, fragrance, titanium dioxide, zinc oxide, chromium hydroxide green

  • 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 - 1 OZ.  28 g

    proactiv®              

    SKIN
    PURIFYING
    MASK                  

    NET. WT. 1 OZ. (28 g)
    sulfur acne medication

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV SKIN PURIFYING MASK 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Synthetic Wax (1200 Mw) (UNII: Q3Z4BCH099)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Sodium Lauroyl Sarcosinate (UNII: 632GS99618)  
    Linolenic Acid (UNII: 0RBV727H71)  
    .alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Cymbopogon Schoenanthus Top (UNII: 9SJI1LW39W)  
    Geranium Maculatum Root (UNII: 93IXI5B6OJ)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Sodium Sulfate (UNII: 0YPR65R21J)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Chromium Hydroxide Green (UNII: RV8FT8XF5R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-013-001 in 1 BOX12/31/201205/14/2019
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11410-013-051 in 1 BOX12/31/2013
    285 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11410-013-101 in 1 BOX09/01/2019
    39 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:11410-013-021 in 1 BOX12/31/2013
    428 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/31/2012
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International Mfg LLC079110793manufacture(11410-013)
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