FDA Label for Astringent
View Indications, Usage & Precautions
Astringent Product Label
The following document was submitted to the FDA by the labeler of this product Granulation Technology, Inc.. 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.
Other
Drug Facts
Manufactured by:
Granulation Technology, Inc.
Fairfield, NJ 07004
Made In USA
Otc - Purpose
Active ingredients (in each packet) | Purpose |
---|---|
Aluminum sulfate tetradecahydrate, 1347 mg | Astringent
When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions. |
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
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 doctorif 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.
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.
- 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:
Other Information
protect from excessive heat
Inactive Ingredients
Dextrin
Questions Or Comments?
1-973-276-0740
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
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