OTC Medication Information: Astringent

ASTRINGENT- calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution
Granulation Technology, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each packet) Purpose
*
When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.
Aluminum sulfate tetradecahydrate, 1347 mg Astringent *
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

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

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

Manufactured by:
Granulation Technology, Inc.
Fairfield, NJ 07004
Made In USA

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 POWDER PACKETS

Principal Display Panel -- 2299 mg Packet Carton
(click image for full-size original)
ASTRINGENT
calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63561-0178
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM ACETATE MONOHYDRATE (CALCIUM CATION) CALCIUM ACETATE MONOHYDRATE 952 mg in 2299 mg
ALUMINUM SULFATE TETRADECAHYDRATE (ALUMINUM CATION) ALUMINUM SULFATE TETRADECAHYDRATE 1347 mg in 2299 mg
Inactive Ingredients
Ingredient Name Strength
MALTODEXTRIN
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63561-0178-2 12 PACKET in 1 CARTON contains a PACKET (63561-0178-1)
1 NDC:63561-0178-1 2299 mg in 1 PACKET This package is contained within the CARTON (63561-0178-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 10/05/2023
Labeler — Granulation Technology, Inc. (847132193)
Registrant — Granulation Technology, Inc. (847132193)
Establishment
Name Address ID/FEI Operations
Granulation Technology, Inc. 847132193 manufacture (63561-0178)

Revised: 10/2023 Granulation Technology, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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