Prostat Bandage Spray

Prostat Bandage Spray
SPL v2
SPL
SPL Set ID 25e25261-71e1-4fc0-98c6-c1deb9e6b6f9
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 (2720 mg)
Inactive Ingredients
Alcohol Isobutane Butane Propane Copovidone K25-31

Identifiers & Packaging

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

Description

Benzethonium Chloride 0.2% w/w Benzocaine 3.2% w/w 

Purpose

Topical antiseptic Topical anesthetic 


Medication Information

Purpose

Topical antiseptic

Topical anesthetic 

Description

Benzethonium Chloride 0.2% w/w Benzocaine 3.2% w/w 

Uses

First aid to help protect against infection in

minor cuts

scrapes

burns 

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 a prolonged period of time

on large portions of the body 

Other Information

avoid inhaling

use only as directed

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

Principal Display

Active Ingredients

Benzethonium Chloride 0.2% w/w

Benzocaine 3.2% w/w 

Inactive Ingredients

Ethyl alcohol, PVP-VA copolymer, N-Butane, Propane, Isobutane

Stop Use and Ask A Doctor If

redness, swelling, or irritation occurs

infection occurs

condition persists or worsens

symptoms persist for more than 7 days 


Structured Label Content

Uses

First aid to help protect against infection in

minor cuts

scrapes

burns 

Purpose

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 a prolonged period of time

on large portions of the body 

Other Information (Other information)

avoid inhaling

use only as directed

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

Principal Display

Active Ingredients (Active ingredients)

Benzethonium Chloride 0.2% w/w

Benzocaine 3.2% w/w 

Inactive Ingredients (Inactive ingredients)

Ethyl alcohol, PVP-VA copolymer, N-Butane, Propane, Isobutane

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

redness, swelling, or irritation occurs

infection occurs

condition persists or worsens

symptoms persist for more than 7 days 


Advanced Ingredient Data


Raw Label Data

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