YOUR LOGO HERE BURN FIRST AID- benzocaine, benzethonium chloride, and menthol aerosol, spray 
Dixon Investments, Inc.

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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YOUR LOGO HERE BURN SPRAY

Active Ingredients

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

Purpose

Topical Anesthetic
Topical Anesthetic
Topical Anesthetic 

Uses

For temporary relief of pain and ithcing and help protect against infection in
minor cuts and scrapes
burns
sunburnsinsect bitesminor skin irritations

Warnings

For external use only

Flammable

keep away from fire or flame

Do not use

in or near eyes or other mucous membranes
in case of serious burns in deep puncture wounds
for a prolonged period of time
on large portions of the body 

When using this product

avoid spraying in eyes
contents under pressuredo not puncture or incinerate containerdo not store at temperatures above 120°(F)use only as directedintentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal 

Stop use and ask doctor if

redness, swelling, or irritation occurs
infection occurs
conditions 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

clean the affected area
shake can well before using
hold 4-6 inches from surface and spray area until wet
for adult institutional use only
not intended for use on children 

Inactive Ingredient

Dipropylene glycol, isobutane, n-butane, and propane

Principal Display

image description

YOUR LOGO HERE BURN FIRST AID 
benzocaine, benzethonium chloride, and menthol aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52982-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE8500 mg  in 85 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE170 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:52982-101-0385 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/05/2013
2NDC:52982-101-0114.2 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/05/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/05/2013
Labeler - Dixon Investments, Inc. (115315822)
Registrant - Dixon Investments, Inc. (115315822)
Establishment
NameAddressID/FEIBusiness Operations
Dixon Investments, Inc.115315822manufacture(52982-101)

Revised: 1/2023
Document Id: f2a48124-0794-51c2-e053-2a95a90aa1af
Set id: 57d1a917-d635-4e7b-a49a-6b3d175af326
Version: 6
Effective Time: 20230109
 
Dixon Investments, Inc.