FDA Label for Astringent Solution
View Indications, Usage & Precautions
Astringent Solution Product Label
The following document was submitted to the FDA by the labeler of this product First Nation Group. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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
Otc - 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
Otc - 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.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.
Otc - 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.
- 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.
- 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.
For use as a soak:
For use as a compress or wet dressing:
Storage And Handling
Protect from excessive heat.
Inactive Ingredient
Dextrin
Otc - Questions
1-855-221-5332
Distributed by:
First Nation Group, LLC
Niceville, FL 32578
* Please review the disclaimer below.
