ZO SKIN HEALTH ASTRINGENT SOLUTION- aluminum acetate powder 
ZO Skin Health, Inc.

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.

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ZO® Skin Health Astringent Solution Powder
National Drug Code 42851-090-06

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.

US Astringent Powder Principal Display Panel

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)

Revised: 10/2022
Document Id: ea51529d-5271-c941-e053-2a95a90ab8cd
Set id: cb801d7e-52ad-6c16-e053-2a95a90a7a1f
Version: 5
Effective Time: 20221005
 
ZO Skin Health, Inc.