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

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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ProStat Pain Relieving 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, 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

image description

PROSTAT BURN FIRST AID 
benzethonium chloride, benzocaine, and menthol aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-0105(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:58228-0105-385 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/18/2014
Labeler - ProStat First Aid (061263699)
Registrant - Dixon Investments, Inc. (115315822)
Establishment
NameAddressID/FEIBusiness Operations
Dixon Investments, Inc.115315822manufacture(58228-0105)

Revised: 3/2014
Document Id: 7518092e-2c65-42be-bf2e-8a665defe6c1
Set id: 0d490ebb-adc9-4f06-8e23-992abafbf151
Version: 4
Effective Time: 20140307
 
ProStat First Aid