0.5% Lidocaine Burn Relief Gel
FDA Label NDC 43473-099

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nantong Health & Beyond Hygienic Products Inc. for the product 0.5% Lidocaine Burn Relief (NDC 43473-099). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine HCl 0.5%

Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations

Warnings

For external use only

Do not usein large quantities, particularly over raw surfaces or blistered areas

When using this productavoid contact with the eyes

Stop use and ask a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

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 of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor

Other Information

Store a room temperature • Protect from direct sunlight.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Disodium EDTA, Ethylhexylglycerin, FD&C Blue NO.1, FD&C Yellow NO.5, Glycerin, Menthol, Maltodextrin, Propanediol, Polysorbate 20, Phenoxyethanol, Sodium Hydroxide, SD Alcohol, Water.

Packaging

0.5% Lidocaine Burn Relief (52000437 6)

0.5% Lidocaine Burn Relief (52000437 6)

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