FIRST AID BURN- lidocaine hydrochloride spray

First Aid Burn by

Drug Labeling and Warnings

First Aid Burn by is a Otc medication manufactured, distributed, or labeled by Unishield . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for 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 a 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 Poison Control Center right away

Directions

• for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
• for children under 2 years of age consult a physician

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

Questions?

call 1-800-480-5855

Principal Display Panel - 59.1 mL Bottle Label

UniShield

FIRST AID
BURN
SPRAY

For Temporary
Pain Relief of
Minor Burns

NET CONTENTS 2 FL.OZ. (59.1 ML)

Distributed by: UniShield, San Fernando, CA 91340
Made in USA

INGREDIENTS AND APPEARANCE

FIRST AID BURN 
lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-5100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	20 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
propylene glycol (UNII: 6DC9Q167V3)
diazolidinyl urea (UNII: H5RIZ3MPW4)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-5100-4	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/07/2019

Labeler - Unishield (790677053)