JJ CARE BURN- lidocaine hydrochloride gel

JJ Care BURN by

Drug Labeling and Warnings

JJ Care BURN by is a Otc medication manufactured, distributed, or labeled by Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Lidocaine HCI         2%

PURPOSE

Purpose

Topical Pain Relief

INDICATIONS & USAGE

Uses

Temporary pain relief for minor burns.

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

■ in large quantities, particularly over raw or blistered areas

■ near eyes, if this happens rinse thoroughly with water

STOP USE

Stop use and ask a doctorif the condition worsens or persists for more than 7 days or clears up and occurs again

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

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age or older

■ Apply to affected area not more than 4 times daily

Chilrdren under 2 years old

■ Do not use, consult a doctor

INACTIVE INGREDIENT

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Phenoxyethanol, Polyethylene Glycol, Tocopheryl Acetate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JJ CARE BURN 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43473-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 934 (UNII: Z135WT9208)
MENTHOL (UNII: L7T10EIP3A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43473-069-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product	02/19/2025
2	NDC: 43473-069-02	160 in 1 PACKAGE	02/19/2025
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/19/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(43473-069)