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 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, Phenoxyethanol, Propylene glycol, purified water, stearic acid, Triethanolamine.

Questions

To reorder:

Call 1-888-296-9067

Fax: 1-888-878-3609

Online: www.trifecta-pharma.com

Reorder No. 4050

Questions or Comments?

Call: 1-888-296-9067

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:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

PURPOSE

First Aid Antiseptic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN CREAM 
benzalkonium chloride, lidocaine hci cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.005 g  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 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: 69396-105-09	144 in 1 CARTON	09/27/2022
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	M013	09/27/2022

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)