Drug Details [pdf]

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71183-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 71183-008-02	0.9 g in 1 PACKET; Type 0: Not a Combination Product	05/01/2016	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2016	01/01/2019

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

Drug Labeling and Warnings

Drug Details [pdf]