BURN CREAM- benzalkonium chloride, lidocaine hci cream

Burn Cream by

Drug Labeling and Warnings

Burn Cream by is a Otc medication manufactured, distributed, or labeled by Prostat First Aid, Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCL 0.5%

Purpose

Topical Analgesic

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

Temporary Relief of pain associated with minor cuts, scrapes and burns.

Helps protect against harmful bacteria.

Warnings

For external Use Only

Do not use

• in eyes
• in large quantities
• over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
• for more than one week unless directed by a doctor

Directions

• Clean the affected area
• Apply a small amount not more than 3 times daily
• May be covered with a sterile bandage

Inactive Ingredients

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, PEG 100 Stearate, Phenoxyethanol, Propylene glycol, purified water, stearic acid, Sodium Hydroxide, Stearic Acid

Questions

Questions

Call 1-888-900-2920

Monday - Friday 8AM - 4PM PST

Storage Information

• Store in cool dry area 15° to 25°C (59° to 77°F).
• tamper evident sealed packets
• do not use any opened or torn packets

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

Distributed By:

ProStat First Aid LLC

La Verne, CA 91750

Part No 2677

PURPOSE

First Aid Antiseptic

Label

LABEL

INGREDIENTS AND APPEARANCE

BURN CREAM 
benzalkonium chloride, lidocaine hci cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-7010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-7010-1	10 in 1 BOX	01/13/2026
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 58228-7010-2	2000 in 1 BAG	01/13/2026
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	M003	01/13/2026

Labeler - Prostat First Aid (061263699)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)