ASTRINGENT- calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution

Astringent by

Drug Labeling and Warnings

Astringent by is a Otc medication manufactured, distributed, or labeled by TAGI Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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 mg	Astringent*
Calcium acetate monohydrate, 952 mg	Astringent*

Uses

temporarily relieves minor skin irritations due to:

• poison ivy
• poison oak
• poison sumac
• insect bites
• athlete's foot
• 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

• dissolve 1 to 3 packets in a pint (16 oz) of cool or warm water
• stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3 packets) aluminum acetate and is ready for use.

For use as a soak:

• soak affected area for 15 to 30 minutes as needed, or as directed by a doctor
• repeat 3 times a day or as directed by a doctor
• discard solution after each 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 from excessive heat

Inactive ingredients

dextrin

Questions or comments?

1-855-225-8244

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ASTRINGENT 
calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51224-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Calcium acetate monohydrate (UNII: 7ZA48GIM5H) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium acetate monohydrate	952 mg  in 2299 mg
Aluminum sulfate tetradecahydrate (UNII: E3UT66504P) (Aluminum Cation - UNII:3XHB1D032B)	Aluminum sulfate tetradecahydrate	1347 mg  in 2299 mg

Inactive Ingredients
Ingredient Name	Strength
icodextrin (UNII: 2NX48Z0A9G)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51224-162-24	12 in 1 CARTON	06/01/2012
1	NDC: 51224-162-12	12 in 1 BOX
1	NDC: 51224-162-99	2299 mg in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	06/01/2012

Labeler - TAGI Pharma Inc. (963322560)