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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP), BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Available from:

ProStat First Aid

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical antiseptic Topical anesthetic  Treatment of minor cuts and abrasions Pain relief Helps prevent infection Soothes itching  In or eyes or near mucous membranes For serious burns Deep puncture wounds For a prolonged period of time Irritation, redness, or swelling increases Rash or infection occurs Condition worsens or symptoms persist for more than 7 days. 

Authorization status:

OTC monograph not final

Summary of Product characteristics

PROSTAT ANTISEPTIC FIRST AID- BENZOCAINE AND BENZETHONIUM CHLORIDE
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 ANTISEPTIC SPRAY
ACTIVE INGREDIENTS
Benzethonium Chloride 0.2% w/w
Benzocaine 10% w/w
PURPOS E
Topical antiseptic
Topical anesthetic
US ES
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
PROSTAT ANTISEPTIC FIRST AID
benzocaine and benzethonium chloride aerosol, spray
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:58 228 -0 10 4(NDC:529 8 2-10 0 )
ROUTE OF ADMINISTRATION
TOPICAL
ProStat First Aid
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -
UNII:1VU15B70 BP)
BENZETHONIUM
CHLORIDE
170 mg in 8 5 g
BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)
BENZOCAINE
8 50