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

Active ingredients
(click image for full-size original)

Lidocaine Hydrochloride 0.5%

Purpose

Purpose

Topical Anesthetic

Uses

Uses

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

Warnings

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 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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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