ZO MEDICAL SURFATROL ASTRINGENT (ALUMINUM ACETATE) POWDER [ZO SKIN HEALTH, INC.]

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ZO MEDICAL SURFATROL ASTRINGENT (ALUMINUM ACETATE) POWDER [ZO SKIN HEALTH, INC.]
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NDC 42851-084-19
Set ID 82f31fa8-960f-42c4-a0b1-9f91bad825b3
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    *
    When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions
    Aluminum Sulfate Tetradecahydrate, 2850 mgAstringent*
    Calcium Acetate Monohydrate, 2016 mgAstringent*
  • Uses

    For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.

  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • do not cover compress or wet dressing with plastic to prevent evaporation
    • in some skin conditions, soaking too long may overdry

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days

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

  • Directions

    • dissolve 1 packet in 12 oz. of cool or warm water.
    • stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.45% aluminum acetate and is ready for use.

    For use as a compress or wet dressing:

    • dip clean gauze in the solution
    • apply gauze loosely to affected area for 1 to 2 minutes
    • repeat 3-4 times a day as needed or as directed by a doctor
    • discard solution after each use
  • Other information

    • Store at a comfortable temperature range indoors, usually considered to be 68 to 77°F (20 to 25°C).
    • Avoid storing at extreme temperatures above 104°F (40°C).
  • Inactive ingredients

    Water, Dextrin, Avena Sativa (Oat) Kernel Protein, Glycine Soja (Soybean) Protein, Whey Protein, Potassium Sorbate, Chitosan.

  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - 6 g Packet Carton

    ZO®MEDICAL
    BY ZEIN OBAGI MD

    NDC 42851-084-19

    SURFATROL™
    Astringent Solution
    Powder

    10 ea. Net Wt. 6 g / 0.21 Oz.

    PRINCIPAL DISPLAY PANEL - 6 g Packet Carton
  • INGREDIENTS AND APPEARANCE
    ZO MEDICAL SURFATROL ASTRINGENT 
    aluminum acetate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-084
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Acetate (UNII: 80EHD8I43D) (Aluminum Cation - UNII:3XHB1D032B) Aluminum Acetate4866 mg  in 4.866 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Whey (UNII: 8617Z5FMF6)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-084-1910 in 1 CARTON08/01/2016
    16 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34708/01/2016
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paramount Cosmetics001321058MANUFACTURE(42851-084)
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