BURN MIST- lidocaine hydrochloride spray

Burn Mist by

Drug Labeling and Warnings

Burn Mist by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DOSAGE & ADMINISTRATION

• 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: consult 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?

1-800-275-3433   info@waterjel.com   www.waterjel.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

BURN MIST 
lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-201-10	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/17/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/17/2010

Labeler - Water-Jel Technologies (155522589)

Registrant - Water-Jel Technologies (155522589)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(59898-201)