BURN EASE COOLING- lidocaine gel

Burn Ease Cooling by

Drug Labeling and Warnings

Burn Ease Cooling by is a Otc medication manufactured, distributed, or labeled by ProStat First Aid LLC, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine Hydrochloride 2%

Purpose

Topical Pain Relief

Use(s)

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

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 (1-800-222-1222) right away.

Directions

Apply an even layer of burn gel over cleaned affected area not more than 3-4 times daily

Not to be used on children under 12 years of age

Other Information

store at 68-77F (20-25C)

• tamper evident sealed packets
• do not use any opened or torn packets

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl propanol, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Polyethylene glycol, Phenoxyethanol, Tocopheryl Acetate, Water

Questions?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN EASE COOLING 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-2893
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
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MENTHOL (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-2893-5	2000 in 1 PACKAGE	09/17/2025
1		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	09/17/2025

Labeler - ProStat First Aid LLC (061263699)

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

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(58228-2893)