FDA.reportPublic FDA data

Astringent Solution

Manufacturer
Granulation Technology, Inc.
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:02:50

Label at a glance#

ProductAstringent
Active ingredientCALCIUM ACETATE MONOHYDRATE, ALUMINUM SULFATE TETRADECAHYDRATE
Label structure10 sections

Indications and 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

Dosage and administration

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...

Storage and handling

Protect from excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each packet) Purpose
Aluminum sulfate tetradecahydrate, 1347 mgAstringent *
Calcium acetate monohydrate, 952 mgAstringent *

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

Protect from excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dextrin

Questions or comments?

OTC - QUESTIONS SECTION

1-973-276-0740

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 2299 mg Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63561-0178-02

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

astringent-cartonastringent-carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1250234aluminum sulfate 1347 MG / calcium acetate 952 MG in 160 ML Topical SolutionPSN3
1250234aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical SolutionSCD3
1250234(3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Topical SolutionSY3
1250234aluminum sulfate 1347 MG / calcium acetate 952 MG per 160 ML Topical SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63561-0178-22025-02-21C16284748780-12cef2736-5d12-d83d-e063-dadaa90ab31fAstringent Solution
63561-0178-22025-01-30C16284748780-12cef2736-5d12-d83d-e063-dadaa90ab31fAstringent Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0178-1Astringent2299 mg in 1 PACKETPOWDER, FOR SOLUTION22993
63561-0178-2Astringent12 in 1 CARTONPOWDER, FOR SOLUTION123

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63561-017863561-0178-1, 63561-0178-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
CALCIUM ACETATE MONOHYDRATE7ZA48GIM5HACTIB
ALUMINUM SULFATE TETRADECAHYDRATEE3UT66504PACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AstringentCALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATEGranulation Technology, Inc.1c2bf19c-2f32-4a22-a371-16cc744dce762025-06-12WarningsExact identifier
ndc (package): 63561-0178-2
ndc (package): 63561-0178-1
ndc (product): 63561-0178
ndc11 (package): 63561017802
ndc11 (package): 63561017801
spl id: 37553cf5-a897-fef9-e063-6394a90a7812
spl set id: 1c2bf19c-2f32-4a22-a371-16cc744dce76

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.