ASTRINGENT SOLUTION- aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution 
First Nation Group

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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Active Ingredients (in each packet) Purpose

Aluminum sulfate tetradecahydrate, 1347 mg Astringent*
Calcium acetate monohydrate, 952 mg Astringent*

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

Uses

Temporarily relieves minor skin irritations due to:

Temporarily relieves minor skin irritations due to:

FOR EXTERNAL USE ONLY

When using this product

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 use as a soak:

For use as a compress or wet dressing:

Protect from excessive heat.

Dextrin

1-855-221-5332

Distributed by:

First Nation Group, LLC

Niceville, FL 32578

Package Display

ASTRINGENT SOLUTION 
aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81469-999
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION952 mg  in 2299 mg
ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT66504P) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM CATION1347 mg  in 2299 mg
Inactive Ingredients
Ingredient NameStrength
ICODEXTRIN (UNII: 2NX48Z0A9G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81469-999-1212 in 1 BOX09/27/2023
1NDC:81469-999-012299 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34709/27/2023
Labeler - First Nation Group (078875731)

Revised: 9/2023
Document Id: 065c53a2-3605-24d4-e063-6394a90a0e5d
Set id: 065c895c-7d86-f1ed-e063-6394a90a3a52
Version: 1
Effective Time: 20230927
 
First Nation Group