UNISHIELD FIRST AID BURN- lidocaine hcl 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.

----------

Unishield
First Aid Burn Spray

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

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 a Poison Control Center right away.

Directions

Inactive ingredients

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

Questions or comments?

1-800-480-5855

Package Label - Principal Display Panel

image of bottle label

UNISHIELD FIRST AID BURN 
lidocaine hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TEA TREE OIL (UNII: VIF565UC2G)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49314-0002-159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/20/2023
Labeler - Unishield (790677053)

Revised: 3/2023
Document Id: f729c666-669e-4605-e053-6394a90a426e
Set id: f729c557-da4b-3fb5-e053-6394a90a4196
Version: 1
Effective Time: 20230318
 
Unishield