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

  • NDC Code(s): 16864-240-01, 16864-240-10, 16864-240-14
  • Packager: Advantice Health, LLC.
  • 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 January 19, 2020

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  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Active Ingredients (in each packet)Purpose
    Aluminum sulfate tetradecahydrate, 1347 mgAstringent*
    Calcium acetate monohydrate, 952 mgAstringent*
    *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.
  • 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
  • STORAGE AND HANDLING

    Other information protect from excessive heat

  • INACTIVE INGREDIENT

    Inactive ingredients dextrin

  • Questions or comments?

    1-800-345-0032
    www.domeboro.com

  • SPL UNCLASSIFIED SECTION

    Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927

  • PRINCIPAL DISPLAY PANEL - 12 Packet Box

    DOCTOR RECOMMENDED
    DOMEBORO®
    Aluminum Sulfate Tetradecahydrate / Calcium Acetate Monohydrate-Astringent

    Burow's Solution
    Relief Since 1958

    CALMING & SOOTHING
    Medicated Soak

    RASH RELIEF
    PLUS DRYING ACTION

    EFFECTIVE FOR POISON IVY, OAK,
    SUMAC & OTHER RASHES

    Dries Oozing
    Rashes

    Relieves Itching
    & Burning

    Reduces
    Blistering

    12 POWDER
    PACKETS

    RELIEF AT LAST

    NET WT 0.1 OZ
    (2.7 G) EACH

    PRINCIPAL DISPLAY PANEL - 12 Packet Box
  • INGREDIENTS AND APPEARANCE
    DOMEBORO  
    aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT66504P) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM SULFATE TETRADECAHYDRATE1347 mg
    Calcium Acetate Monohydrate (UNII: 7ZA48GIM5H) (Acetate Ion - UNII:569DQM74SC) Calcium Acetate Monohydrate952 mg
    Inactive Ingredients
    Ingredient NameStrength
    Icodextrin (UNII: 2NX48Z0A9G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-240-0112 in 1 BOX; Type 0: Not a Combination Product06/26/2012
    2NDC:16864-240-10100 in 1 BOX; Type 0: Not a Combination Product06/26/201204/30/2017
    3NDC:16864-240-1414 in 1 BOX; Type 0: Not a Combination Product06/26/201207/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34706/26/2012
    Labeler - Advantice Health, LLC. (192527062)
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