Drugplain

Astringent 1347 mg/2299mg

Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate · POWDER, FOR SOLUTION · Granulation Technology, Inc.

5 Recalls on RecordCurrently in Shortage
Plain English

Astringent is a powder, for solution containing calcium acetate monohydrate and aluminum sulfate tetradecahydrate at 1347 mg/2299mg, taken topical. Manufactured by Granulation Technology, Inc..

Key Facts

Brand Name
Astringent
Generic Name
Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate
NDC Code (Product)
63561-0178
Manufacturer
Granulation Technology, Inc.
Strength
1347 mg/2299mg
Dosage Form
POWDER, FOR SOLUTION
Route
TOPICAL
Marketing Status
Application #
part347
Marketing Start
06/12/2025

Recall History

5 Recalls on Record
Class II01/16/2014

The Mentholatum Co.

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

TerminatedVoluntary: Firm initiated
Class III10/15/2012

Valeant Pharmaceuticals

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.

TerminatedVoluntary: Firm initiated
Class II08/07/2014

New Gpc Inc.

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

TerminatedVoluntary: Firm initiated
Class III12/04/2014

K C Pharmaceuticals Inc

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

TerminatedVoluntary: Firm initiated
Class II01/16/2014

The Mentholatum Co.

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache205 reports
vomiting204 reports
pruritus202 reports
condition aggravated186 reports
drug ineffective183 reports
weight decreased177 reports
nausea176 reports
hypertension174 reports
infection174 reports
urticaria169 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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% (3packets) 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.

Warnings

FOR EXTERNAL USE ONLY

Frequently Asked Questions

What is Astringent used for?

Astringent contains Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate. It is a powder, for solution taken topical. Consult your doctor for specific uses.

Is Astringent a controlled substance?

Astringent is not classified as a controlled substance by the DEA.

What is the generic name for Astringent?

The generic name for Astringent is Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate. There are no other listed brand versions of Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate.

What is the NDC code for Astringent 1347 mg/2299mg?

The NDC (National Drug Code) for Astringent 1347 mg/2299mg is 63561-0178, listed by Granulation Technology, Inc..

Product NDC

63561-0178

Package NDC

63561-0178-2

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)