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Lidothol Gel
  • Professionals
  • FDA PI

Lidothol Gel

Generic name:lidocaine, menthol
Dosage form: gel
Drug class:Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Lidothol Gel

(Lidocaine 4.5%, Menthol 5%)

Rx only

Lidothol Gel Description

Lidothol Gel (Lidocaine 4.5%, Menthol 5%) is comprised of a gel inside of a tube containing 4.5% Lidocaine and 5% Menthol.

Inactive ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Boswellia Serrata Gum Extract, Butylene Glycol, Dimethyl Sulfone, Ethylhexylglycerin, llex Paraguariensis Leaf Extract, Magnesium Sulfate, Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water

Lidothol Gel - Clinical Pharmacology

Pharmacodynamics

Lidocaine is an amide-type local anesthetic agent. The penetration of lidocaine into intact skin after application of Lidothol Gel is sufficient to produce annalgesic effect, but less than the amount necessary to produce a complete sensory block.

Menthol is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol induces a cooling sensation on the skin upon topical application by stimulating the cold-sensitive receptors expressed on the skin, without actually causing a drop in the skin temperature.

Pharmacokinetics

Absorption

The amount of lidocaine systemically absorbed from Lidothol Gel is directly related to both the duration of application and the surface area over which it is applied.

Menthol occurs in numerous over-the-counter products. Although extensively used, there have been no estimates of human exposure following administration via dermal application.

Distribution

At concentrations produced by application of Lidothol Gel, approximately 70% of the lidocaine dose is reported to be bound to plasma proteins, primarily alpha-1-acid glycoprotein. At higher plasma concentrations (1 to 4 mcg/mL of free base), the plasma protein binding of lidocaine is concentration dependent.

Metabolism

It is not known if Lidothol Gel is metabolized in the skin.

Excretion

Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocai...