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

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 November 20, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 mgAstringent*
    Calcium acetate monohydrate, 952 mgAstringent*
  • 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?

    1-855-225-8244

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Epic Pharma, LLC
    Laurelton, NY 11413

    Distributed by:
    TAGI Pharma
    South Beloit, IL 61080

  • PRINCIPAL DISPLAY PANEL - 2299 mg Packet Carton

    NDC 51224-162-12

    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
    ®

    tagiPHARMA

    12 POWDER PACKETS

    Principal Display Panel - 2299 mg Packet Carton
  • INGREDIENTS AND APPEARANCE
    ASTRINGENT 
    calcium acetate monohydrate and aluminum sulfate tetradecahydrate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51224-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium acetate monohydrate (UNII: 7ZA48GIM5H) (Calcium Cation - UNII:2M83C4R6ZB) Calcium acetate monohydrate952 mg  in 2299 mg
    Aluminum sulfate tetradecahydrate (UNII: E3UT66504P) (Aluminum Cation - UNII:3XHB1D032B) Aluminum sulfate tetradecahydrate1347 mg  in 2299 mg
    Inactive Ingredients
    Ingredient NameStrength
    icodextrin (UNII: 2NX48Z0A9G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51224-162-2412 in 1 CARTON06/01/2012
    1NDC:51224-162-1212 in 1 BOX
    1NDC:51224-162-992299 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34706/01/2012
    Labeler - TAGI Pharma Inc. (963322560)