Prostat Pain Relieving Burn Spray

Prostat Pain Relieving Burn Spray
SPL v4
SPL
SPL Set ID 0d490ebb-adc9-4f06-8e23-992abafbf151
Route
TOPICAL
Published
Effective Date 2014-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-18

Description

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

Purpose

Topical Anesthetic Topical Antiseptic Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Topical Antiseptic

Topical Anesthetic

Description

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

Uses

For temporary relief of pain, itching and to help protect against infection in

minor cuts and scrapes

burns

sunburns

insect bites

minor skin irritations 

Warnings

For external use only

Flammable

keep away from fire or flame

contents under pressure

do not puncture or incinerate container

do not expose to temperatures above 120° F 

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 prolonged period of time

on large portions of the body

Principal Display

Inactive Ingredients

dipropylene glycol, isobutane, n-butane, propane

other Information

avoid spraying in eyes

use only as directed

intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal 

active Ingredients

Benzocaine 10% w/w

Benzethonium Chloride .2% w/w

Menthol .33% w/w

Stop Use and Ask A Doctor If

redness, swelling, or irritation occurs

infection occurs

conditions worsen or symptoms persist for more than 7 days 


Structured Label Content

Uses

For temporary relief of pain, itching and to help protect against infection in

minor cuts and scrapes

burns

sunburns

insect bites

minor skin irritations 

Purpose

Topical Anesthetic

Topical Antiseptic

Topical Anesthetic

Warnings

For external use only

Flammable

keep away from fire or flame

contents under pressure

do not puncture or incinerate container

do not expose to temperatures above 120° F 

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 prolonged period of time

on large portions of the body

Principal Display

Inactive Ingredients

dipropylene glycol, isobutane, n-butane, propane

other Information (Other information)

avoid spraying in eyes

use only as directed

intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal 

active Ingredients (Active Ingredients)

Benzocaine 10% w/w

Benzethonium Chloride .2% w/w

Menthol .33% w/w

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

redness, swelling, or irritation occurs

infection occurs

conditions worsen or symptoms persist for more than 7 days 


Advanced Ingredient Data


Raw Label Data

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