Label: THERAPEUTIC SULFUR MASK- 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 September 12, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                                                     Purpose
    Sulfur 3.5%...................................................................................................................................Acne Treatment
  • INDICATIONS & USAGE

    Use for the treatment of acne
  • WARNINGS

    Warnings For external use only
  • DO NOT USE

    Do not use
    • If you have a known allergy to salicylic acid or aspirin.
  • WHEN USING

    When using this product
    • Using other topical acne medications at the same time or immediately following use of this product may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
    • Avoid contact with lips and mouth. Do not get into eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
  • STOP USE

    Stop use and consult a doctor if excessive skin irritation develops or increases, discontinue use and consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    Gently massage into clean wet skin for two to three minutes until mask turns light blue for maximum absorption. Leave on for an additional 10 minutes, until dry. Rinse off with warm water and pat dry. You may experience a tightening and cooling effect. Some individuals may find the cooling feeling too strong - simply rinse off the mask immediately if uncomfortable. Use 2-3 times per week, or as desired. Avoid eye and lip areas. Avoid unnecessary sun exposure and use a sunscreen.
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Acacia Senegal Gum, Bentonite, Butylene Glycol, Cellulose, Copper Gluconate, Ethylhexylglycerin, Hydroxypropyl Methylcellulose, Kaolin, Magnesium Aluminum Silicate, Magnesium Aspartate, Magnesium Stearate, Mannitol, Menthyl Lactate, Methylisothiazolinone, Phenoxyethanol, Soidum Ascobyl Phosphate, Sodium Cocoyl Isethionate, Spiraea Ulmaria Flower Extract, Tetrasodium EDTA, Titanium Dioxide, Ultramarines (CI 77007), Water/Aqua/Eau, Zinc PCA.
  • PURPOSE

    Purpose: Acne Treatment

  • PRINCIPAL DISPLAY PANEL

    AcneFree Clear Skin Treatments
    Tube Artwork
    Carton Artwork
  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC SULFUR MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur35 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    kaolin (UNII: 24H4NWX5CO)  
    bentonite (UNII: A3N5ZCN45C)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    ACACIA (UNII: 5C5403N26O)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    menthyl lactate (UNII: 2BF9E65L7I)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    butylene glycol (UNII: 3XUS85K0RA)  
    mannitol (UNII: 3OWL53L36A)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    magnesium aspartate (UNII: R17X820ROL)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50544-004-911 in 1 CARTON
    1NDC:50544-004-0248 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/06/2011
    Labeler - University Medical Pharmaceuticals Corp (809706252)
    Registrant - University Medical Pharmaceuticals Corp (809706252)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, INC177711082manufacture
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