ASTRINGENT- calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution 
Granulation Technology, 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 doctorif 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?

1-973-276-0740

Manufactured by:
Granulation Technology, Inc.
Fairfield, NJ 07004
Made In USA

PRINCIPAL DISPLAY PANEL - 2299 mg Packet Carton

NDC 63561-0178-2

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
®

Granulation Technology, Inc.

12 POWDERPACKETS

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:63561-0178
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63561-0178-212 in 1 CARTON10/05/2023
1NDC:63561-0178-12299 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 finalpart34710/05/2023
Labeler - Granulation Technology, Inc. (847132193)
Registrant - Granulation Technology, Inc. (847132193)
Establishment
NameAddressID/FEIBusiness Operations
Granulation Technology, Inc.847132193manufacture(63561-0178)

Revised: 10/2023
Document Id: 06e6abb2-42ec-5536-e063-6394a90a8a79
Set id: 1c2bf19c-2f32-4a22-a371-16cc744dce76
Version: 1
Effective Time: 20231004
 
Granulation Technology, Inc.