Label: ZO SKIN HEALTH ASTRINGENT SOLUTION- aluminum acetate powder

  • 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 October 5, 2022

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  • Drug Facts

    Active IngredientsPurpose
    Aluminum Sulfate Tetradecahydrate, 2850 mgAstringent*
    Calcium AcetateMonohydrate, 2016 mgAstringent*

    *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions

    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 reach of children.

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

    Directions

    For powder dosage form:

    ■ 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:
    ■ soak a clean, soft cloth in the solution
    ■ apply cloth loosely to affected area for
    15 to 30 minutes
    ■ repeat as needed or as directed by a doctor
    ■ discard solution after each use

    Other Information

    ■ Protect this product from excessive heat and direct sun

    Inactive Ingredients

    Avena Sativa (Oat) Kernel Protein, Chitosan, Dextrin, Hydrolyzed Soy Protein, Potassium Sorbate, Whey Protein.

  • PRINCIPAL DISPLAY PANEL

    US Astringent Powder Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH ASTRINGENT SOLUTION 
    aluminum acetate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE4866 mg  in 6 g
    Inactive Ingredients
    Ingredient NameStrength
    WHEY (UNII: 8617Z5FMF6)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-090-066 g in 1 PACKET; Type 0: Not a Combination Product02/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/21/2022
    Labeler - ZO Skin Health, Inc. (826468527)
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