Domeboro Powder, For Solution
FDA Label NDC 16864-240

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advantice Health, Llc. for the product Domeboro (NDC 16864-240). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, when using this product, otc - stop use, otc - keep out of reach of children, directions, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

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

Otc - Stop Use

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

Otc - 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.

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

Other

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)

Principal Display Panel (12 Packet Box)

* Please review the disclaimer below.