AEROBURN BURN FIRST AID- benzethonium chloride, benzocaine, and menthol aerosol, spray 
Aero Healthcare, 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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AEROBURN BURN SPRAY

Active Ingredients

Benzocaine 10% w/w
Benzethonium Chloride .2% w/w
Menthol .33% w/w

Purpose

Topical Anesthetic
Topical Antiseptic
Topical Anesthetic

Uses

For temporary relief of pain, treatment and helps prevent infection in

Warnings

For external use only

Flammable

Do not use

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive Ingredients

Dipropylene Glycol, Isobutane, n-Butane, Propane

Principal Display

image description

AEROBURN BURN FIRST AID 
benzethonium chloride, benzocaine, and menthol aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-116(NDC:52982-101)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE170 mg  in 85 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE8500 mg  in 85 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL281 mg  in 85 g
Inactive Ingredients
Ingredient NameStrength
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ISOBUTANE (UNII: BXR49TP611)  
BUTANE (UNII: 6LV4FOR43R)  
PROPANE (UNII: T75W9911L6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55305-116-1085 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/20/2014
Labeler - Aero Healthcare, LLC. (008186174)
Registrant - Dixon Investments, Inc. (115315822)
Establishment
NameAddressID/FEIBusiness Operations
Dixon Investments, Inc.115315822manufacture(55305-116)

Revised: 9/2014
Document Id: d0e2594d-82eb-47d1-992d-c22824c639cf
Set id: b780da38-8568-43e1-ab4a-5b69e4f55b19
Version: 1
Effective Time: 20140924
 
Aero Healthcare, LLC.