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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0011-7714.2 g in 1 CAN; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/01/201806/04/2024
PYROCAINE BURN 
benzocaine, benzethonium chloride aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0010-3614.2 g in 1 CAN; Type 0: Not a Combination Product03/20/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/20/201306/04/2024
Labeler - Honeywell Safety Products USA. Inc (118768815)
Establishment
NameAddressID/FEIBusiness Operations
Dixon Investments115315822manufacture(0498-0011, 0498-0010)

Revised: 6/2024
 
Honeywell Safety Products USA. Inc