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

Domeboro by

Drug Labeling and Warnings

Domeboro by is a Otc medication manufactured, distributed, or labeled by MOBERG PHARMA NORTH AMERICA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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

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 - Advantice Health, LLC. (192527062)