LIDOCAINE HYDROCHLORIDE GEL- paraaid burn relief gel gel 
Essentials Biotech Co, Ltd.

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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MCURE HEALTH SOLUTIONS INC.

20189 CURRIER ROAD, SUITE 200

CITY OF INDUSTRY, CA 91789

Active Ingredient Purpose

Lidocaine HCI 2.0% Topical Pain Relief

Uses
Temporary pain relief for minor burns


Directions
• Adults and children 2 years and older: apply 3 to 4 times daily
• Children under 2: do not use, consult with a doctor

Inactive Ingredients
Aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

Warnings
For external use only.
Keep out of reach of childre.
Do not use
• near eyes, if this happens, rinse thoroughly with water
• in large quantities, particularly over raw or blistered areas. Stop use, ask a doctor
• if condition worsens or lasts more than 7 days or clears up and returns. If ingested, contact a poison control center directly

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

BURN GEL

LIDOCAINE HYDROCHLORIDE GEL 
paraaid burn relief gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71183-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 1342 (UNII: 809Y72KV36)  
MENTHOL (UNII: L7T10EIP3A)  
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
PROPYLENE GLYCOL 1-BEHENATE (UNII: 293K4PAQ2T)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71183-008-020.9 g in 1 PACKET; Type 0: Not a Combination Product05/01/201601/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/201601/01/2019
Labeler - Essentials Biotech Co, Ltd. (544530742)

Revised: 10/2019
Document Id: 96400fd7-0ed2-4115-e053-2a95a90a5b3c
Set id: 79df12b2-ba78-61e4-e053-2991aa0a734a
Version: 2
Effective Time: 20191031
 
Essentials Biotech Co, Ltd.