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 Tagi Pharma 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:
Epic Pharma, LLC
Laurelton, NY 11413

Distributed by:
TAGI Pharma
South Beloit, IL 61080


Otc - Purpose



Active ingredients (in each packet)Purpose
Aluminum sulfate tetradecahydrate, 1347 mgAstringent

When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.

Calcium acetate monohydrate, 952 mgAstringent

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 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.


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


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


* Please review the disclaimer below.