Label: ACNE CLEARING 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 February 16, 2022

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

  • Drug Facts

  • Active ingredient

    Sulfur 3.5%

    Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    Do not use on

    • broken skin
    • large areas of the skin

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • gently massage into clean wet skin for two to three minutes until mask turns light blue
    • leave on for an additional 10 minutes, until dry
    • rinse off with warm water and pat dry
    • if you experience a tightening and cooling effect that you find too strong, rinse off the mask immediately if uncomfortable
    • use 2-3 times per week, or as desired
    • avoid the eye and lip areas
  • Other information

    • store at 59°–95° F (15°–35° C)
    • avoid product contact with silver jewelry, which may be discolored by this product
  • Inactive ingredients

    acacia senegal gum, bentonite, butylene glycol, cellulose, copper gluconate, ethylhexylglycerin, hydroxypropyl methylcellulose, kaolin, magnesium aluminum silicate, magnesium aspartate, magnesium stearate, mannitol, methyl lactate, methylisothiazolinone, phenoxyethanol, sodium ascorbyl phosphate, sodium cocoyl isethionate, spirea ulmaria extract, tetrasodium EDTA, titanium dioxide, ultramarines, water, zinc gluconate, zinc PCA

  • Questions or comments?

    1-888-768-2913

  • Package Labeling:

    LabelTube

  • INGREDIENTS AND APPEARANCE
    ACNE CLEARING SULFUR MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    METHYL LACTATE, (-)- (UNII: 0379G9C44S)  
    ACACIA (UNII: 5C5403N26O)  
    BENTONITE (UNII: A3N5ZCN45C)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    WATER (UNII: 059QF0KO0R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80861-001-011 in 1 CARTON12/01/2017
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2017
    Labeler - AcneFree, LLC (122237140)