PROSTAT FIRST AID BURN EASE, 0.9G- lidocaine gel

PROSTAT FIRST AID Burn Ease, 0.9g by

Drug Labeling and Warnings

PROSTAT FIRST AID Burn Ease, 0.9g 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

any opened or torn packets

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

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

PROSTAT FIRST AID BURN EASE, 0.9G 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-2012
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)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-2012-1	900 in 1 CARTON	09/30/2025
1		25 in 1 BOX
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	09/30/2025

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(58228-2012)