MEDI-FIRST BURN- lidocaine hcl spray
Unifirst First Aid 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.

----------

Medi-First Burn Spray

Drug Facts

Active ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief associated with minor burns

Warnings

For external use only.

Do not use

in large quantities, particularly over raw or blistered areas
near eyes, if this happens rinse thoroughly with water

Stop use and ask doctor if

condition worsens or persists for more than 7 days or clears up and returns.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
not to be used on children under 12 years of age

Inactive ingredients

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydronated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Questions or comments? 1-800-634-7680

Medi-First Burn Spray Label

Medi-First°

Burn Spray

Pump Spray

Lidocaine HCl 2.0%

Topical Analgesic

Relieves pain in minor burns

Store at 68°-77°F (20°-25°C)

2 FL OZ (59.1 ML)

MF Burn

MEDI-FIRST BURN
lidocaine hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-255
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSES (UNII: 3NXW29V3WO)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47682-255-02	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/01/2021

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 11/2020

Document Id: b3ebf104-cc52-0ef5-e053-2a95a90a25c9

Set id: b3ebf104-cc51-0ef5-e053-2a95a90a25c9

Version: 1

Effective Time: 20201112

Unifirst First Aid Corporation