Your Logo Here Burn Spray

Your Logo Here Burn Spray
SPL v7
SPL
SPL Set ID 57d1a917-d635-4e7b-a49a-6b3d175af326
Route
TOPICAL
Published
Effective Date 2013-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (8500 mg) Benzethonium (170 mg) Menthol (281 mg)
Inactive Ingredients
Dipropylene Glycol Isobutane Butane Propane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-05

Description

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

Purpose

Topical Anesthetic Topical Anesthetic Topical Anesthetic 


Medication Information

Purpose

Topical Anesthetic

Topical Anesthetic

Topical Anesthetic 

Description

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

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

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 

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 

Principal Display

Active Ingredients

Benzocaine 10% w/w

Benzethonium Chloride .2% w/w

Menthol .33% w/w 

Inactive Ingredient

Dipropylene glycol, isobutane, n-butane, and propane

Stop Use and Ask Doctor If

redness, swelling, or irritation occurs

infection occurs

conditions worsens or symptoms persist for more than 7 days 

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 

Keep Out of Reach of Children

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


Structured Label Content

Purpose

Topical Anesthetic

Topical Anesthetic

Topical Anesthetic 

uses (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

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 

Do Not Use (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 

Principal Display

Active Ingredients

Benzocaine 10% w/w

Benzethonium Chloride .2% w/w

Menthol .33% w/w 

Inactive Ingredient

Dipropylene glycol, isobutane, n-butane, and propane

Stop Use and Ask Doctor If (Stop use and ask doctor if)

redness, swelling, or irritation occurs

infection occurs

conditions worsens or symptoms persist for more than 7 days 

when Using This Product (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 

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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