ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT (SULFUR) CREAM [ZO SKIN HEALTH, INC.]

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ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT (SULFUR) CREAM [ZO SKIN HEALTH, INC.]
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NDC 42851-073-54, 42851-073-85
Set ID f9c40784-744a-4d92-b54b-084ad5b3c000
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
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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.
  • Inactive Ingredients

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

  • SPL UNCLASSIFIED SECTION

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

    Made in USA

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    ZO ® SKIN HEALTH

    BY ZEIN OBAGI MD

    NDC 42851-073-85

    Offects® Sulfur Masque

    Acne Treatment

    Net Wt. 85 g / 3 Oz.

    US Offects Sulfur Masque Box

  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-073
    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:42851-073-851 in 1 CARTON05/01/2015
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:42851-073-54540 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/01/2015
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.081239587manufacture(42851-073)
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