FIRST AID BURN- lidocaine hydrochloride spray 
Unishield

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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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

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

Principal Display Panel - 59.1 mL Bottle Label
FIRST AID BURN 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-5100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
propylene glycol (UNII: 6DC9Q167V3)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49314-5100-459.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/07/2019
Labeler - Unishield (790677053)

Revised: 10/2019
Document Id: 06a2ae14-a264-4da5-97cf-d061a0257c46
Set id: aebcfa2a-fdd8-4118-abe3-c8579a614cc7
Version: 1
Effective Time: 20191007
 
Unishield