Astringent Powder, For Solution
FDA Label NDC 63561-0178

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Granulation Technology, Inc. for the product Astringent (NDC 63561-0178). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 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 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.

    • 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?

1-973-276-0740

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

Principal Display Panel (2299 mg Packet Carton)

Principal Display Panel (2299 mg Packet Carton)

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