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

  • Label RSS
  • 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • 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.)

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  • Purpose

    Astringent

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  • 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
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  • 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.

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  • Directions

    • mix one, two, or three packets in 16 oz of water to obtain the following modified Burrow's Solution
    Number of Packets Dilution % Aluminum acetate
    one packet 1:40 dilution 0.14%
    two packets 1:20 dilution 0.28%
    three packets 1:13 dilution 0.42%
    • 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
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  • Other information

    protect from excessive heat

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  • Inactive ingredients

    dextrin

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  • Questions or comments?

    1-888-EPIC-RX1

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    TAGI Pharma
    South Beloit, IL 61080

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  • 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
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  • INGREDIENTS AND APPEARANCE
    ALUMINUM ACETATE ASTRINGENT 
    calcium acetate and aluminum sulfate powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51224-153
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Calcium Acetate (Calcium Cation) Calcium Acetate 839 mg  in 2030 mg
    Aluminum sulfate (Aluminum Cation) Aluminum sulfate 1191 mg  in 2030 mg
    Inactive Ingredients
    Ingredient Name Strength
    icodextrin  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51224-153-24 12 in 1 CARTON
    1 NDC:51224-153-12 12 in 1 BOX
    1 NDC:51224-153-99 2030 mg in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 06/15/2011
    Labeler - TAGI Pharma Incorporated (963322560)
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