Label: ALUMINUM ACETATE ASTRINGENT- calcium acetate and aluminum sulfate powder, for solution

  • NDC Code(s): 51224-153-12, 51224-153-24, 51224-153-99
  • Packager: TAGI Pharma Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 20, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each packet)

    Aluminum acetate

    (Each powder packet, when mixed in water and ready for use, provides the active ingredient aluminum acetate resulting from the reaction of calcium acetate 839 mg and aluminum sulfate 1191 mg.)

  • Purpose

    Astringent

  • 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
    • 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

    • mix one, two, or three packets in 16 oz of water to obtain the following modified Burrow's Solution
    Number of PacketsDilution% Aluminum acetate
    one packet1:40 dilution0.14%
    two packets1:20 dilution0.28%
    three packets1:13 dilution0.42%
    • do not strain or filter the solution
    • can be used as a compress, wet dressing, or a soak
    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
    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
  • Other information

    protect from excessive heat

  • Inactive ingredients

    dextrin

  • Questions or comments?

    1-888-EPIC-RX1

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    TAGI Pharma
    South Beloit, IL 61080

  • PRINCIPAL DISPLAY PANEL - 12 Powder Packets Carton

    NDC 51224-153-24

    ALUMINUM ACETATE
    ASTRINGENT SOLUTION

    Soothing, Effective Relief of Minor Skin Irritations due to:

    Poison Ivy
    Athlete's Foot
    Insect Bites
    Rashes

    tagi PHARMA

    Manufactured by:
    Epic Pharma, LLC
    Laurelton, NY 11413

    Made in USA

    Distributed by:
    TAGI Pharma
    South Beloit, IL 61080

    12 POWDER PACKETS

    PRINCIPAL DISPLAY PANEL - 12 Powder Packets Carton
  • INGREDIENTS AND APPEARANCE
    ALUMINUM ACETATE ASTRINGENT 
    calcium acetate and aluminum sulfate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51224-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Acetate (UNII: Y882YXF34X) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Acetate839 mg  in 2030 mg
    Aluminum sulfate (UNII: 34S289N54E) (Aluminum sulfate anhydrous - UNII:I7T908772F) Aluminum sulfate1191 mg  in 2030 mg
    Inactive Ingredients
    Ingredient NameStrength
    icodextrin (UNII: 2NX48Z0A9G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51224-153-2412 in 1 CARTON06/15/2011
    1NDC:51224-153-1212 in 1 BOX
    1NDC:51224-153-992030 mg in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/15/2011
    Labeler - TAGI Pharma Incorporated (963322560)