Label: GLYTONE ACNE TREATMENT MASK- sulfur cream
GLYTONE ACNE CLARIFYING TREATMENT MASK- sulfur cream

  • NDC Code(s): 64760-710-01, 64760-714-01
  • Packager: Pierre Fabre USA Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 3, 2024

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

  • Drug Facts

  • Active ingredient

    Sulfur 6.4%

  • Purpose

    Acne Treatment

  • Use  For the treatment of acne.

    • Dries and clears acne blemishes and allows skin to heal.
    • Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads.
    • Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
  • Warnings

    For external use only

    Flammable: Keep away from fire or flame

    Flammable: Keep away from fire or flame.

    Do not use on

    • broken skin
    • large areas of the skin

    When using this product

    • apply only to areas with acne
    • 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.
    • avoid contact with eyes. If eye contact occurs, flush thoroughly with water.

    Stop use and ask a doctor

    • if excessive skin irritation develops or increases.

    Keep out of reach of children.

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

  • Directions

    • Before first use, break the safety seal by twisting the inverted cap over the star-shaped seal.

    • Cleanse the skin thoroughly before applying this mask.

    • Apply a generous amount to the entire face and neck, or as directed by your physician.

    • Avoid eyes, nostrils, and lips.

    • Leave on skin for 20-25 minutes.

    • Remove with lukewarm water in a gentle circular motion. Pat dry.

    • Use one to three times a week, or as directed by your physician.

  • Other information

    Store at room temperature of 68-77° F (20-25° C)

  • Inactive Ingredients

    WATER, BENTONITE, ISOPROPYL ALCOHOL, KAOLIN, ZINC OXIDE, GLYCERIN, CALCIUM OXIDE, COCAMIDE MIPA, FRAGRANCE, METHYLPARABEN, SODIUM LAURYL SULFATE.

  • Principal Display Panel - 85 g - Glytone Acne Treatment Mask Carton

    GLYTONE

    Acne

    Treatment

    Mask

    ACNE THERAPY

    6.4% SULFUR

    NET WT. 85 g / 3 OZ.

    AcneTreatmentMask

  • Principal Display Panel - 85 g - Glytone Acne Clarifying Treatment Mask Carton

    GLYTONE

    ACNE CLARIFYING TREATMENT MASK

    ACNE THERAPY

    6.4% SULFUR

    1% GLYCOLIC ACID

    1% LACTIC ACID

    NET WT. 85 G / 3 OZ.

    Acne Clarifying Treatment Mask

  • INGREDIENTS AND APPEARANCE
    GLYTONE ACNE TREATMENT MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR64 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-710-011 in 1 CARTON03/14/2018
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/14/201806/05/2024
    GLYTONE ACNE CLARIFYING TREATMENT MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-714
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR64 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LACTIC ACID LACTATE, L- (UNII: 26T86KT372)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BISABOLOL OXIDE A (UNII: 16AE65F94Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL RICINOLEATE (UNII: ZUE0CEL42O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-714-011 in 1 CARTON06/23/202310/10/2024
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00606/23/202310/10/2024
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)