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, Cetyl alcohol, Diazolidinyl urea, Edetate disodium, glycerin, methylparaben, Mineral oil, Mono and di glycerides, PEG-100 stearate, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Questions

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

Package Label

Package Label

INGREDIENTS AND APPEARANCE

BURN CREAM 
benzalkonium chloride, lidocaine hci cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-136
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
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-136-10	10 in 1 CARTON	10/23/2023
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69396-136-25	25 in 1 CARTON	10/23/2023
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	10/23/2023

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)