PROSTAT BURN FIRST AID- benzethonium chloride, benzocaine, and menthol aerosol, spray

ProStat Burn First Aid by

Drug Labeling and Warnings

ProStat Burn First Aid by is a Otc medication manufactured, distributed, or labeled by ProStat First Aid, Dixon Investments, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, 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 

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

Stop use and ask a doctor if

redness, swelling, or irritation occurs
infection occurs
conditions worsen 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 

Other information

avoid spraying in eyes
use only as directed
intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal 

Inactive Ingredients

dipropylene glycol, isobutane, n-butane, propane

Principal Display

INGREDIENTS AND APPEARANCE

PROSTAT BURN FIRST AID 
benzethonium chloride, benzocaine, and menthol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-0105(NDC:52982-101)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	170 mg  in 85 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	8500 mg  in 85 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	281 mg  in 85 g

Inactive Ingredients
Ingredient Name	Strength
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ISOBUTANE (UNII: BXR49TP611)
BUTANE (UNII: 6LV4FOR43R)
PROPANE (UNII: T75W9911L6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-0105-3	85 g in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/18/2014

Labeler - ProStat First Aid (061263699)

Registrant - Dixon Investments, Inc. (115315822)

Establishment
Name	Address	ID/FEI	Business Operations
Dixon Investments, Inc.		115315822	manufacture(58228-0105)