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: unapproved drug other

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Drug Label Information

Updated January 17, 2024

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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

  • 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 DrugM01201/01/2018
    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 Product03/20/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/20/2013
    Labeler - Honeywell Safety Products USA. Inc (118768815)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments115315822manufacture(0498-0011, 0498-0010)
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