Label: PROACTIV REFINING MASK- sulfur cream

  • NDC Code(s): 11410-507-36
  • Packager: THE PROACTIV COMPANY 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 March 26, 2019

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

  • 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

    • do not use this product more than three times per day.
    • skin irritation and dryness are 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 

    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.
    • apply a small amount to dampened skin.
    • 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, ceteareth-20, sodium lauroyl sarcosinate, linolenic acid, tocopheryl acetate, tocopherol, butylene glycol, melaleuca alternifolia (tea tree) leaf oil, cymbopogon schoenanthus extract, geranium maculatum extract, hydrated silica, ethoxydiglycol, methylparaben, ethylparaben, fragrance, titanium dioxide, zinc oxide

    Questions or comments?
    Within US 1-800-950-4695

  • SPL UNCLASSIFIED SECTION

    Distributed by The Proactiv Company LLC
    100 N. Sepulveda Blvd.
    El Segundo, CA 90245 ● proactiv.com
    Made in the USA of Foreign and Domestic Components
    Proactiv is a trademark of The Proactiv Company Sàrl.

  • PRINCIPAL DISPLAY PANEL - 100 g Tube Label

    proactiv®                    

    REFINING
    MASK

    3.5 OZ. 100 g

    sulfur acne medication

    Proactiv Refining Mask Tube
  • INGREDIENTS AND APPEARANCE
    PROACTIV REFINING MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-507
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur0.06 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Glycereth-26 (UNII: NNE56F2N14)  
    Cymbopogon Schoenanthus Top (UNII: 9SJI1LW39W)  
    Geranium Maculatum Root (UNII: 93IXI5B6OJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-507-36100 g in 1 TUBE; Type 0: Not a Combination Product12/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/01/1998
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-507)