BURN RELIEF- lidocaine hci 2.0% spray

Burn Relief by

Drug Labeling and Warnings

Burn Relief 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 HCI 2.0%

Purpose

Topical Pain Relief

INDICATIONS & USAGE

Temporary pain relief associated with minor burns.

Warnings

For External Use Only

Stop use and ask a doctor

• If the condition worsens or persists for more than 7 days or clears up and returns.

Keep out of the reach of children

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

Do Not Use

• In large quantities, particularly over raw or blistered areas
• Near eyes, if this happens rinse throughly with water

Directions

• Spray an even layer of burn spray 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 controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

Glycerin, hydroxypropyl methylcellulose, melaleuca alternifilia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol propylene glycol, triethanolamine, water

Questions or Comments

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4049

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF 
lidocaine hci 2.0% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-107-02	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/28/2022

Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)