Label: ASTRINGENT SOLUTION- aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution

  • NDC Code(s): 81469-999-01, 81469-999-12
  • Packager: First Nation Group
  • 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 September 27, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients (in each packet) Purpose

    Aluminum sulfate tetradecahydrate, 1347 mg Astringent*
    Calcium acetate monohydrate, 952 mg Astringent*

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

  • 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
  • PURPOSE

    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

    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

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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.
  • STORAGE AND HANDLING

    Protect from excessive heat.

  • INACTIVE INGREDIENT

    Dextrin

  • QUESTIONS

    1-855-221-5332

    Distributed by:

    First Nation Group, LLC

    Niceville, FL 32578

  • PRINCIPAL DISPLAY PANEL

    Package Display

  • INGREDIENTS AND APPEARANCE
    ASTRINGENT SOLUTION 
    aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81469-999
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION952 mg  in 2299 mg
    ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT66504P) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM CATION1347 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:81469-999-1212 in 1 BOX09/27/2023
    1NDC:81469-999-012299 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 finalpart34709/27/2023
    Labeler - First Nation Group (078875731)