PROSTAT ANTISEPTIC FIRST AID- benzocaine and benzethonium chloride aerosol, spray

ProStat Antiseptic First Aid by

Drug Labeling and Warnings

ProStat Antiseptic 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

Benzethonium Chloride 0.2% w/w
Benzocaine 10% w/w 

Purpose

Topical antiseptic
Topical anesthetic 

Uses

Treatment of minor cuts and abrasions
Pain relief
Helps prevent infection
Soothes itching 

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 eyes or near mucous membranes
For serious burns
Deep puncture wounds
For a prolonged period of time

Stop use and ask a doctor if

Irritation, redness, or swelling increases
Rash or infection occurs
Condition 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

Hold 4-6 inches from surface
Spray area until wet
Clean the affected area
Shake can well before using
For adult institutional use only
Not intended for use on children 

Other information

Avoid inhaling
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 ANTISEPTIC FIRST AID 
benzocaine and benzethonium chloride aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-0104(NDC:52982-100)
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

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: 58228-0104-3	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(58228-0104)