PYROCAINE BURN- benzocaine, benzethonium chloride aerosol, spray
Honeywell Safety Products USA. Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0498-0011 & 0498-0010: Pyrocaine Burn Spray

Active Ingredient

Benzocaine 20%

Benzethonium chloride 0.2%

Purpose

Topical anesthetic

Topical antiseptic

Uses

For the temporary relief of pain and itching, and to help protect against skin infection in:

minor burns
minor skin irritations
minor cuts and scrapes
insect bites
sunburns

Warnings

For external use only

Flammable

keep away from fire or flame
contents under pressure
do not puncture, incinerate or expose container to temperatures above 120 o F

Do not use

in or near the eyes or over large portions of the body
in case of deep or puncture wounds or on:
raw surfaces
blistered areas
animal bites
serious burns

Stop use and ask a doctor if

If condition persists or worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few 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 can 6 to 12 inches away from the affected area and spray liberally
apply to affected area not more than 3 times daily
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

butane,dipropylene glycol, isobutane, propane

Principal Display Panel

Pyrocaine

Pyrocaine Burn Old

swift pyrocaine

PYROCAINE BURN
benzocaine, benzethonium chloride aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-0011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
1,1,3-TRI(3-TERT-BUTYL-4-HYDROXY-6-METHYLPHENYL)BUTANE (UNII: BF6E9O0XJN)
ISOBUTANE (UNII: BXR49TP611)
1,1,3-TRIS(2-CHLOROETHOXY)PROPANE (UNII: 4FEX9N888E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0011-77	14.2 g in 1 CAN; Type 0: Not a Combination Product	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	01/01/2018	06/04/2024

PYROCAINE BURN
benzocaine, benzethonium chloride aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-0010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIPROPYLENE GLYCOL (UNII: E107L85C40)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0010-36	14.2 g in 1 CAN; Type 0: Not a Combination Product	03/20/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/20/2013	06/04/2024

Labeler - Honeywell Safety Products USA. Inc (118768815)

Name	Address	ID/FEI	Business Operations
Establishment
Dixon Investments		115315822	manufacture(0498-0011, 0498-0010)

Revised: 6/2024

Document Id: 1a1655a0-5fc0-1634-e063-6294a90aeb64

Set id: 791a7505-dea5-418d-98e8-709ae6140a37

Version: 20

Effective Time: 20240604

Honeywell Safety Products USA. Inc