DOMEBORO- aluminum acetate gel

DOMEBORO by

Drug Labeling and Warnings

DOMEBORO by is a Otc medication manufactured, distributed, or labeled by Advantice Health, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Aluminum Acetate 0.5%

Purpose

Astringent

Uses

temporarily relieves minor skin irritations due to:

• poison ivy
• poison oak
• poison sumac
• insect bite
• 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.

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

Use only as directed

• Apply liberally to the affected area as needed or as directed by a doctor.
• Repeat three times a day or as directed by a doctor.

Other information

Store below 77°F with cap closed.

Inactive ingredients

Boric Acid, Ethanol, Glycerin, Hydrochloric Acid, Hypromellose, Menthol, Polysorbate 20, Propylene Glycol, Purified Water

Questions or comments

Call (800) 345-0032 or visit www.domeboro.com

SPL UNCLASSIFIED SECTION

Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

DOCTOR RECOMMENDED
DOMEBORO®
Aluminum Acetate 0.5% - Astringent

Burrow's
Solution

Relief
Since 1958

MAXIMUM STRENGTH
COOLING
GEL

COMPLETE
RASH RELIEF

FOR RASHES CAUSED BY
POISON IVY, OAK,
SUMAC & SKIN IRRITANTS

• Relieves Itch
• Cooling Relief
  in Seconds
  PLUS
• Dries Oozing
  Rashes
• Reduces Redness

No Mess, Hands-Free Application

NET WT 3 OZ (85g)

INGREDIENTS AND APPEARANCE

DOMEBORO 
aluminum acetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ACETATE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-250-01	1 in 1 CARTON	04/15/2020
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	04/15/2020

Labeler - Advantice Health, LLC. (192527062)