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.

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Coolest Burn Relief 16oz

Active Ingredients

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

other warning

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. Stop use

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. do not use

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children

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 Directions

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. Inactive ingredients

Questions or comments?

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

Front Label

BURN RELIEF GEL
lidocaine hydrochloride gel

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

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

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

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

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

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

Labeler - Cross Brands Contract Filling (116950257)

Name	Address	ID/FEI	Business Operations
Establishment
Cross Brands Contract Filling		116950257	manufacture(73440-2161) , pack(73440-2161) , label(73440-2161)

Revised: 2/2021

Document Id: bad5f763-74db-ee72-e053-2a95a90a34ce

Set id: bad5f763-74da-ee72-e053-2a95a90a34ce

Version: 1

Effective Time: 20210208

Cross Brands Contract Filling