0.5% LIDOCAINE BURN RELIEF- lidocaine hydrochloride gel

0.5% LIDOCAINE BURN RELIEF by

Drug Labeling and Warnings

0.5% LIDOCAINE BURN RELIEF 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]

Drug Facts

Active ingredient

Lidocaine HCl 0.5%

Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations

Warnings

For external use only

Do not usein large quantities, particularly over raw surfaces or blistered areas

When using this productavoid contact with the eyes

Stop use and ask a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur 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

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Other information

Store a room temperature  Protect from direct sunlight.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Disodium EDTA, Ethylhexylglycerin, FD&C Blue NO.1, FD&C Yellow NO.5, Glycerin, Menthol, Maltodextrin, Propanediol, Polysorbate 20, Phenoxyethanol, Sodium Hydroxide, SD Alcohol, Water.

SPL UNCLASSIFIED SECTION

✓ Soothes & Cools Minor Burns

✓ Menthol Formula for Fast Pain Relief

✓ Helps Prevent Infection

PAIN RELIEVING GEL WITH ALOE

Mfd for and Distributed by:
Universal Distribution Center LLC
330 Applegarth Road, Monroe Township, NJ 08831
www.universaldc.com

MADE IN CHINA

Packaging

INGREDIENTS AND APPEARANCE

0.5% LIDOCAINE BURN RELIEF 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43473-099
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PROPANEDIOL (UNII: 5965N8W85T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43473-099-08	3 in 1 BOX	02/21/2026
1		226 g in 1 BOTTLE, PLASTIC; 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	02/21/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(43473-099)