BURN RELIEF GEL- lidocaine hydrochloride gel

Burn Relief Gel by

Drug Labeling and Warnings

Burn Relief Gel by is a Otc medication manufactured, distributed, or labeled by Cross Brands Contract Filling. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine Hydrochloride 0.5%

Purpose

Topical Anesthetic

Uses

Temporary relief of pain and itching. Helps to relieve and soothe pain from sunburn, minor burns, skin irritations, scrapes, insect bites.

Warnings

For external use only

Other Warnings

Avoid Contact with eyes.

Stop use and ask a doctor if:

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Pregnancy/breast-feeding warning

If pregnant or breast-feeding, as a health care professional before use.

Do not use

in large quantity, particularly over raw surfaces or areas with blisters.

Keep out of reach of children.

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

Directions

Adults and children 2 years or older: apply generously to the burned area. Repeat application as often as necessary (no more than four times daily) to further extinguish pain. Children under 2 years of age: do not use, ask a doctor

Inactive ingredients

acrylates/C1030 alkyl acrylate crosspolymer, alcohol denatured, algae extract, aloe barbadensis leaf juice, butylene glycol, ehtylhexylglycerin, FD&C Blue No. 1, fragrance, glycerin, menthyl lactate, PEG-40 hydrogenated castor oil, phenoxyethanol, polysorbate 20, PPG-26-butheth-26, simmondsia chinensis (jojoba) extract, triethanolamine, water.

Questions or comments?

Call 855-sea-n-ski (855-732-6754) or visit www.seaNski.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF GEL 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73440-2161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.4123 g  in 482.46 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	436.1 g  in 482.46 g

Product Characteristics
Color	blue (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73440-2161-1	482.46 g in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/08/2021

Labeler - Cross Brands Contract Filling (117871824)

Establishment
Name	Address	ID/FEI	Business Operations
Cross Brands Contract Filling		117871824	label(73440-2161) , manufacture(73440-2161) , pack(73440-2161)