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

Astringent Solution by

Drug Labeling and Warnings

Astringent Solution by is a Otc medication manufactured, distributed, or labeled by First Nation Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

INDICATIONS & USAGE

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

PURPOSE

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

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

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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% (3packets) 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.

STORAGE AND HANDLING

Protect from excessive heat.

INACTIVE INGREDIENT

Dextrin

QUESTIONS

1-855-221-5332

Distributed by:

First Nation Group, LLC

Niceville, FL 32578

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81469-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	952 mg  in 2299 mg
ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT66504P) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM CATION	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: 81469-999-12	12 in 1 BOX	09/27/2023
1	NDC: 81469-999-01	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 Drug	M016	09/27/2023

Labeler - First Nation Group (078875731)