Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

DOMEBORO COOLING - aluminum acetate gel 
MOBERG PHARMA NORTH AMERICA LLC

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.

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Drug Facts

• Active Ingredient: Purpose
• Aluminum Acetate 0.5%: Astringent

Uses:  temporarily relives 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 apply to open wounds

Stop use and ask a doctor if condition worsens or symptoms persis 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.

Inactive Ingredients:

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

Other Information:

Store below 77°F with cap closed.

Questions or comments

Call 1-(800) 345-0032 or visit www.domeboro.com

Distributed by
Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2015 All Rights Reserved.
Made in the USA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

Domeboro®
Aluminum Acetate Astringent

Cooling gel

Complete Rash Relief
for rashes caused by Poison Ivy, Oak, Sumac & Skin Irritants

Relieves Itch 
Cools on Contact

PLUS

Dries ozzing rashes 
Reduces redness

No Mess, Hands-Free Application

3 FL OZ (90mL)

Hands Free Application

Clear, Odorless and Fast Drying

Trusted for over 50 years Domeboro® provides soothing effective relief of skin irritations.

Distributed by
Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2015 All Rights Reserved.
Made in the USA.

Questions of comments?
1-800-345-0032
www.domeboro.com

82-4101-02

DOMEBORO COOLING 
aluminum acetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aluminum Acetate (UNII: 80EHD8I43D) (Aluminum Cation - UNII:3XHB1D032B)	Aluminum Acetate	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid (UNII: R57ZHV85D4)
Alcohol (UNII: 3K9958V90M)
Glycerin (UNII: PDC6A3C0OX)
Hydrochloric Acid (UNII: QTT17582CB)
Hypromelloses (UNII: 3NXW29V3WO)
Menthol (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: 16864-192-01	1 in 1 CARTON	03/01/2016	06/30/2019
1		90 mL 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	03/01/2016	06/30/2019

Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)

Establishment
Name	Address	ID/FEI	Business Operations
SmartScience Laboratories, Inc.		035907919	manufacture(16864-192)

Revised: 9/2018

Document Id: 39c2f318-9c6c-46a2-889d-51bdfadaa7c6

34390-5

Set id: bf91802f-210f-1875-88f0-14be2c00457b

Version: 4

Effective Time: 20180917