Drug Facts

Active Ingredient

Lidocaine HCl 2.0%

Purpose

Topical Pain Relief

Uses

Temporary pain relief for minor burns.

Warnings:

For external use only

Do not use

ln large quantities, particularly over raw or blistered areas.
Near the eyes; if this happens rinse thoroughly with water.

Stop use and ask doctor if

Condition worsens or persists for more than 7 days or clears up and occurs again within a few days.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

For adults and children 2 years and older: apply to affected area not more than 4 times daily.
Children under 2 years old: do not use, consult a doctor.

lnactive lngredients

Water, Polyethylene Glycol, Carbomer, Aloe Barbadensis Leaf Juice, Maltodextrin, Ethylhexylglycerin, Phenoxyethanol, Menthol, Tocopheryl Acetate, Triethanolamine

Questions or Comments?

1-833-420-1183

Burn Gel

image of pouch label

BURN
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43473-048
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MENTHOL (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43473-048-01	0.9 g in 1 POUCH; Type 0: Not a Combination Product	11/04/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/04/2022

Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)

43473-048 JJ Care Burn Gel