OTC Medication Information: Burn Relief Gel

BURN RELIEF GEL- lidocaine hydrochloride gel
Cross Brands Contract Filling

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

BURN RELIEF GEL lidocaine hydrochloride gel

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.4123 g in 482.46 g

Inactive Ingredients Ingredient Name Strength WATER 436.1 g in 482.46 g

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73440-2161-1 482.46 g in 1 BOTTLE None

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	Operations
Cross Brands Contract Filling		117871824	label (73440-2161), manufacture (73440-2161), pack (73440-2161)

Revised: 02/2021 Cross Brands Contract Filling