Active Ingredients
Lidocaine Hydrochloride 0.5%
Burn Relief Gel
FDA Label NDC 73440-2161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cross Brands Contract Filling for the product Burn Relief Gel (NDC 73440-2161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, other warnings, stop use and ask a doctor if:, pregnancy/breast-feeding warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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