LIDOCAINE HYDROCHLORIDE GEL- paraaid burn relief gel gel

lidocaine hydrochloride gel by

Drug Labeling and Warnings

lidocaine hydrochloride gel by is a Otc medication manufactured, distributed, or labeled by MCURE HEALTH SOLUTIONS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

MCURE HEALTH SOLUTIONS INC.

20189 CURRIER ROAD, SUITE 200

CITY OF INDUSTRY, CA 91789

ACTIVE INGREDIENT

Active Ingredient Purpose

Lidocaine HCI 2.0% Topical Pain Relief

PURPOSE

Uses
Temporary pain relief for minor burns

INDICATIONS & USAGE

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 INGREDIENT

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

WARNINGS

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE GEL 
paraaid burn relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52486-008
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52486-008-02	0.9 g in 1 PACKET; Type 0: Not a Combination Product	05/01/2016

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

Labeler - MCURE HEALTH SOLUTIONS INC. (053034873)

Registrant - MCURE HEALTH SOLUTIONS INC. (053034873)