Label: PYROCAINE BURN- benzocaine, benzethonium chloride aerosol, spray

  • NDC Code(s): 0498-0010-36, 0498-0011-77
  • Packager: Honeywell Safety Products USA. Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 8, 2021

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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 not finalpart34801/01/2018
    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 Product03/20/201312/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/20/201312/31/2017
    Labeler - Honeywell Safety Products USA. Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments115315822manufacture(0498-0010, 0498-0011)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.812503712repack(0498-0011) , relabel(0498-0011)