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 IngredientPurpose
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

carton
DOMEBORO COOLING 
aluminum acetate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aluminum Acetate (UNII: 80EHD8I43D) (Aluminum Cation - UNII:3XHB1D032B) Aluminum Acetate5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16864-192-011 in 1 CARTON03/01/201606/30/2019
190 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/201606/30/2019
Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)
Establishment
NameAddressID/FEIBusiness Operations
SmartScience Laboratories, Inc.035907919manufacture(16864-192)

Revised: 9/2018
 
MOBERG PHARMA NORTH AMERICA LLC