Label: ZO SKIN HEALTH SULFUR MASQUE- 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 May 9, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sulfur 10%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne.
    • Penetrates pores to clear most acne blemishes, blackheads, and whiteheads.
    • Helps prevent new acne blemishes from forming.
  • Warnings

    For external use only.

    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.

    Do not use on

    • broken skin
    • large areas of the skin

    Keep out of reach of children.

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

    • Clean the skin thoroughly before applying this product.
    • Cover the entire affected area with a thin layer twice a week.
    • Suitable for use on face, chest, back or wherever breakouts occur.
    • Leave on for 10-15 minutes and remove thoroughly with warm water, moist towels or cotton pads.
    • If bothersome dryness or peeling occurs, reduce application frequency as directed by your doctor.
    • As a spot treatment: apply a small amount onto the blemish and leave on overnight.
  • Inactive Ingredients

    Water, Talc, Kaolin, Glycerin, Bentonite, Propylene Glycol, Caprylyl Glycol, Ethylene Brassylate, Silica, Tetrasodium EDTA, Phenoxyethanol, Chlorphenesin, Benzyl Alcohol, Ultramarines.

  • SPL UNCLASSIFIED SECTION

    Dist. by ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    ZO ® SKIN HEALTH
    BY ZEIN OBAGI MD

    NDC 42851-089-85

    SULFUR MASQUE
    10% Sulfur

    Net Wt. 85 g / 3 Oz.

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH SULFUR MASQUE 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-089
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENTONITE (UNII: A3N5ZCN45C)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-089-851 in 1 CARTON02/22/201904/09/2022
    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 finalpart333D02/22/2019
    Labeler - ZO Skin Health, Inc. (826468527)
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