FDA Product

Astringent Solution

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Astringent Solution

FDA Product Code

81469-999

Regulatory Information

NDC Product Code

81469-999

Application Number

M016

Marketing Category

C200263

Effective Date

March 3, 2025

Territorial Authority

USA

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

4

Company Information

ManufacturerFirst Nation Group

DUNS Number

078875731

Active Ingredients

ICODEXTRIN

Code: 2NX48Z0A9G

Class Code: IACT

CALCIUM ACETATE MONOHYDRATE

Quantity: 952 mg in 2299 mg

Code: 7ZA48GIM5H

Class Code: ACTIM

ALUMINUM SULFATE TETRADECAHYDRATE

Quantity: 1347 mg in 2299 mg

Code: E3UT66504P

Class Code: ACTIM

Active Moieties

CALCIUM CATION

Code: 2M83C4R6ZB

ALUMINUM CATION

Code: 3XHB1D032B

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