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

  • NDC Code(s): 16864-240-01, 16864-240-10, 16864-240-14
  • Packager: MOBERG PHARMA NORTH AMERICA 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 17, 2018

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.
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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. 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.

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  • 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
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  • STORAGE AND HANDLING

    Other information protect from excessive heat

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  • INACTIVE INGREDIENT

    Inactive ingredients dextrin

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  • Questions or comments?

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

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  • SPL UNCLASSIFIED SECTION

    Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927
    Domeboro is a registered trademark of Moberg Pharma AB
    ©2017 All Rights Reserved. Made in the USA.

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  • PRINCIPAL DISPLAY PANEL

    Doctor Recommended

    Domeboro®

    Aluminum Sulfate Tetradecahydrate / Calcium Acetate Monohydrate - Astringent

    Medicated Soak

    Rash Relief
    Plus Drying Action


    Effective for Poison Ivy, Oak, Sumac & Rash caused by irritants

    • Dries oozing rashes• Soothing relief of itch & burning
    • Reduces redness & blistering
    • Aids healing

    12 Powder Packets

    Domeboro® astringent solution provides soothing, effective relief of minor skin irritations.
    For the last 60 years, Domeboro® astringent solution has been trusted to help relieve minor skin irritations.

    This formula is not sold to any retailer as a store brand.

    Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927
    Domeboro is a registered trademark of Moberg Pharma AB
    © 2017 All Rights Reserved. Made in the USA.

    82-2403-03
    10194-10-17

    Carton
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  • INGREDIENTS AND APPEARANCE
    DOMEBORO  
    aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16864-240
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT66504P) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM SULFATE TETRADECAHYDRATE 1347 mg
    Calcium Acetate Monohydrate (UNII: 7ZA48GIM5H) (Acetate Ion - UNII:569DQM74SC) Calcium Acetate Monohydrate 952 mg
    Inactive Ingredients
    Ingredient Name Strength
    Icodextrin (UNII: 2NX48Z0A9G)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16864-240-01 12 in 1 BOX; Type 0: Not a Combination Product 06/26/2012
    2 NDC:16864-240-10 100 in 1 BOX; Type 0: Not a Combination Product 06/26/2012 04/30/2017
    3 NDC:16864-240-14 14 in 1 BOX; Type 0: Not a Combination Product 06/26/2012 07/31/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 06/26/2012
    Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)
    Establishment
    Name Address ID/FEI Business Operations
    Contract Pharmacal Corporation 057795122 MANUFACTURE(16864-240)
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