FIRST AID ONLY BURN MIST- lidocaine hydrochloride spray

First Aid Only Burn Mist by

Drug Labeling and Warnings

First Aid Only Burn Mist by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. 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

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.

DOSAGE & ADMINISTRATION

Directions

• 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

800.835.2263

Principal Display Panel Bottle Label BurnSpray 2018.jpg

Bottle Label BurnSpray 2018.jpg

INGREDIENTS AND APPEARANCE

FIRST AID ONLY BURN MIST 
lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5750(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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-5750-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2018

Labeler - Acme United Corporation (001180207)

Registrant - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-5750) , repack(0924-5750)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-5750) , repack(0924-5750)