Label: SOOTHING ANTISEPTIC MASK WITH SULFUR- sulfur cream

  • 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 January 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients: Sulfur 10%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Kaolin, Bentonite, Glycerin, Propylene Glycol, Magnesium Aluminum Silicate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Potassium Sorbate, Ethyl hexylglycerin, Phenoxyethanol

  • DOSAGE & ADMINISTRATION

    Directions: apply thin coat over affe3cted area; leave on approximately 20 minutes until completely dry; rinse off with warm watre; use recommended toner to finish cleansing; purified water may be added for smoothr mask consistency

  • INDICATIONS & USAGE

    Uses: treats acne and helps prevent new acne blemishes from forming

  • PURPOSE

    acne mediaction; to treat and prevent acne

  • WARNINGS

    Warnings: For External Use Only

  • WHEN USING

    When using this product: do not use in or near eyes, lips, and mouth

  • ASK DOCTOR

    Consult a doctor: if excessive irritation occurs

  • OTHER SAFETY INFORMATION

    Other information: store at room temperature; keep tightly closed

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

  • PRINCIPAL DISPLAY PANEL

    Soothing Antiseptic Mask with Sulfur

  • INGREDIENTS AND APPEARANCE
    SOOTHING ANTISEPTIC MASK WITH SULFUR 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    BENTONITE (UNII: A3N5ZCN45C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-010-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    2NDC:70367-010-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    3NDC:70367-010-08240 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/26/2014
    Labeler - Only Yourx, Inc. (089207519)
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