BURN- lidocaine hydrochloride gel

Burn by

Drug Labeling and Warnings

Burn by is a Otc medication manufactured, distributed, or labeled by J&A Digital Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

temporary pain relief associated with minor burns

Warnings

For external use only

Do not use

• in large quantities, particularly over raw or blistered areas
• near eyes, if this happens rinse thoroughly with water

Stop use

and ask a doctor if the condition worsens or persists for more than 7 days or clears up and returns.

Keep out of reach of children.

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

Directions

• apply an even layer of gel over cleaned affected area
• not to be used on children under 12 years

Inactive ingredients

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

Burn Gel

INGREDIENTS AND APPEARANCE

BURN 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82942-1001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82942-1001-1	0.9 g in 1 PACKET; Type 0: Not a Combination Product	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2022

Labeler - J&A Digital Inc. (040268672)

Registrant - J&A Digital Inc. (040268672)