Burn Mist (Lidocaine Hydrochloride) Spray [Water-Jel Technologies] -

BURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]
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NDC	59898-201-10
Set ID	c53ab9dd-351a-400b-b873-4f396e0af54d
Category	HUMAN OTC DRUG LABEL
Packager	Water-Jel Technologies
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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

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

INGREDIENTS AND APPEARANCE

BURN MIST
lidocaine hydrochloride spray

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59898-201-10	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/17/2010

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

Labeler - Water-Jel Technologies (155522589)

Registrant - Water-Jel Technologies (155522589)

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

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Medic