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Name:Burn Mist
Manufacturer:Water-jel Technologies
Category:Over-the-counter (OTC) Marketed Drugs


Burn Spray

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.

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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.

  • 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

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BURN MIST 
lidocaine hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59898-201
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 2 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
OCTOXYNOL 9  
GLYCERIN  
HYPROMELLOSE  
TROLAMINE  
TEA TREE OIL  
PROPYLPARABEN  
METHYLPARABEN  
PROPYLENE GLYCOL  
DIAZOLIDINYL UREA  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59898-201-10 59 mL in 1 BOTTLE, SPRAY None

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 Operations
Water-Jel Technologies 155522589 manufacture

Revised: 05/2010 Water-Jel Technologies



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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