ASTRINGENT- calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution 
TAGI Pharma 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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Astringent Solution

Drug Facts

Active ingredients (in each packet)Purpose
*
When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.
Aluminum sulfate tetradecahydrate, 1347 mgAstringent*
Calcium acetate monohydrate, 952 mgAstringent*

Uses

temporarily relieves minor skin irritations due to:

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 use as a soak:

For use as a compress or wet dressing:

Other information

protect from excessive heat

Inactive ingredients

dextrin

Questions or comments?

1-855-225-8244

Manufactured by:
Epic Pharma, LLC
Laurelton, NY 11413

Distributed by:
TAGI Pharma
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 2299 mg Packet Carton

NDC 51224-162-12

ALUMINUM SULFATE TETRADECAHYDRATE / CALCIUM ACETATE MONOHYDRATE
ASTRINGENT SOLUTION

Soothing, Effective Relief of Minor Skin Irritations due to:

Poison Ivy
Athlete's Foot
Insect Bites
Rashes

Compares to the
Active Ingredients
in Domeboro
®

tagiPHARMA

12 POWDER PACKETS

Principal Display Panel - 2299 mg Packet Carton
ASTRINGENT 
calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51224-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium acetate monohydrate (UNII: 7ZA48GIM5H) (Calcium Cation - UNII:2M83C4R6ZB) Calcium acetate monohydrate952 mg  in 2299 mg
Aluminum sulfate tetradecahydrate (UNII: E3UT66504P) (Aluminum Cation - UNII:3XHB1D032B) Aluminum sulfate tetradecahydrate1347 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:51224-162-2412 in 1 CARTON06/01/2012
1NDC:51224-162-1212 in 1 BOX
1NDC:51224-162-992299 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 finalpart34706/01/2012
Labeler - TAGI Pharma Inc. (963322560)

Revised: 11/2018
Document Id: a9a01a44-7d5c-483a-b333-1ca1ff0ab8ef
Set id: 45c351e9-5046-496e-9812-5b8b9abcd4ad
Version: 3
Effective Time: 20181120
 
TAGI Pharma Inc.