Active Ingredient

Lidocaine HCI 2.0%

Purpose

Topical Pain Relief

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

4049 Globe Burn Spray 2oz Rev08 060922 CDER

BURN RELIEF
lidocaine hci 2.0% spray

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

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

Ingredient Name	Strength
Inactive Ingredients
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)
TROLAMINE (UNII: 9O3K93S3TK)
HYPROMELLOSES (UNII: 3NXW29V3WO)

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

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

Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)