Lidocaine Hcl Gel
FDA Label NDC 76162-034

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Lidocaine Hcl (NDC 76162-034). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Adverse Reaction

→ Principal Display Panel

Active Ingredient

Lidocaine HCl 0.5% {w/w}

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 Use

in large quantities, particularly over raw surfaces or blistered areas

When Using This Product

avoid contact with the 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

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

Inactive Ingredients

water, propylene glycol, glycerin, Aloe barbadensis leaf juice, sodium hydroxide, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5