NORTH BURN RELIEF- lidocaine hydrochloride 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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0498-0221 & 0498-0201: Burn Relief Spray

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

Other information

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

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)

Revised: 1/2024
Document Id: 0f8bac8f-57be-a9a4-e063-6294a90a3fb1
Set id: 1297c11d-9c64-4bac-a576-2daad84df94f
Version: 12
Effective Time: 20240122
 
Honeywell Safety Products USA, Inc