Label: ASTRINGENT- calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution
- NDC Code(s): 51224-162-12, 51224-162-24, 51224-162-99
- Packager: TAGI Pharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated March 20, 2023
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
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
- Warnings
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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
- Inactive ingredients
- Questions or comments?
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- PRINCIPAL DISPLAY PANEL - 2299 mg Packet Carton
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INGREDIENTS AND APPEARANCE
ASTRINGENT
calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51224-162 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium acetate monohydrate (UNII: 7ZA48GIM5H) (Calcium Cation - UNII:2M83C4R6ZB) Calcium acetate monohydrate 952 mg in 2299 mg Aluminum sulfate tetradecahydrate (UNII: E3UT66504P) (Aluminum Cation - UNII:3XHB1D032B) Aluminum sulfate tetradecahydrate 1347 mg in 2299 mg Inactive Ingredients Ingredient Name Strength icodextrin (UNII: 2NX48Z0A9G) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51224-162-24 12 in 1 CARTON 06/01/2012 09/30/2024 1 NDC:51224-162-12 12 in 1 BOX 1 NDC:51224-162-99 2299 mg in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 06/01/2012 09/30/2024 Labeler - TAGI Pharma Inc. (963322560)