BURN MIST- lidocaine hydrochloride spray 
Water-Jel Technologies

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.

----------

Burn Spray

Active ingredient

Lidocaine HCl 2%

Purpose

External analgesic

Uses

for the temporary relief of pain associated with minor burns

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas

When using this product

avoid contact with eyes

  • 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.

Other information

store at room temperature

you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive ingredients

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

Questions or comments?


1-800-275-3433 info@waterjel.com www.waterjel.com
Manufactered by Water-Jel Technologies, Inc., 50 Broad Street,
Carlstadt, NJ 07072, USA

Principal Display Panel

BS2

BURN MIST 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
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:59898-201-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/17/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/17/2010
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(59898-201)

Revised: 12/2020
Document Id: b7027975-d7aa-68b2-e053-2a95a90a05bd
Set id: c53ab9dd-351a-400b-b873-4f396e0af54d
Version: 6
Effective Time: 20201221
 
Water-Jel Technologies