Label: NORTH BURN RELIEF- lidocaine hydrochloride spray
BURN RELIEF- lidocaine hydrochloride spray

  • NDC Code(s): 0498-0201-10, 0498-0201-59, 0498-0221-10, 0498-0221-59
  • 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 22, 2024

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  • Active ingredient

    Lidocaine HCl 2%

  • Purpose

    External analgesic

  • Uses

    temporarily relieves pain due to minor burns

  • Warnings

    For external use only

    Do not use

    over large areas of the body, particularly over raw surfaces or blistered areas

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days

    Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Other information

    • store at room temperature
  • Inactive ingredients

    diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

  • Questions or comments?

    1-800-430-5490

  • Principal Display Panel

    burn relief

  • Honeywell Burn Relief

    Honeywell Burn Jel

  • INGREDIENTS AND APPEARANCE
    NORTH BURN RELIEF 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0201-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/18/201709/18/2018
    2NDC:0498-0201-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/15/201309/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/15/201309/18/2018
    BURN RELIEF 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0221-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/18/2018
    2NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Labeler - Honeywell Safety Products USA, Inc (118768815)
    Registrant - Honeywell Safety Products USA, Inc (118768815)
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