Pyrocaine Burn (Benzocaine, Benzethonium Chloride) Aerosol, Spray [Honeywell Safety Products Usa. Inc] -

PYROCAINE BURN (BENZOCAINE, BENZETHONIUM CHLORIDE) AEROSOL, SPRAY [HONEYWELL SAFETY PRODUCTS USA. INC]
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NDC	0498-0010-36, 0498-0011-77
Set ID	791a7505-dea5-418d-98e8-709ae6140a37
Category	HUMAN OTC DRUG LABEL
Packager	Honeywell Safety Products USA. Inc
Generic Name
Product Class
Product Number
Application Number	PART348

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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

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 not final	part348	01/01/2018

PYROCAINE BURN
benzocaine, benzethonium chloride aerosol, spray

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	12/31/2017

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

Labeler - Honeywell Safety Products USA. Inc (079287321)

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

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

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