PYROCAINE BURN- benzocaine, benzethonium chloride aerosol, spray

Pyrocaine Burn by

Drug Labeling and Warnings

Pyrocaine Burn by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA. Inc, Dixon Investments. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Burn Old

INGREDIENTS AND APPEARANCE

PYROCAINE BURN 
benzocaine, benzethonium chloride aerosol, spray

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2018

PYROCAINE BURN 
benzocaine, benzethonium chloride aerosol, spray

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0010-36	14.2 g in 1 CAN; Type 0: Not a Combination Product	03/20/2013	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/20/2013	12/31/2017

Labeler - Honeywell Safety Products USA. Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	pack(0498-0011)

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