FIRST AID ONLY BURN MIST- lidocaine hydrochloride spray 
Acme United Corporation

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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First Aid Only 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

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

800.835.2263

Principal Display Panel

Bottle Label BurnSpray 2018.jpg

Bottle Label BurnSpray 2018.jpg Burn Spray Label

FIRST AID ONLY BURN MIST 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5750(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)  
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:0924-5750-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2018
Labeler - Acme United Corporation (001180207)
Registrant - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-5750) , repack(0924-5750)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-5750) , repack(0924-5750)

Revised: 1/2019
Document Id: 674e0a42-7a82-4fc2-e053-2991aa0ac69a
Set id: 674e0ab6-ee74-46c3-e053-2991aa0a6cad
Version: 1
Effective Time: 20190104
 
Acme United Corporation