LIDOTHOL- lidocaine hcl, menthol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Available from:

Terrain Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidothol Gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

Product summary:

Lidothol Gel is available as the following: 1 tube, 3.5oz NDC 53225-1026-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. For more information, contact Terrain Pharmaceuticals. [e-mail] Manufactured for: Terrain Pharmaceuticals Reno, NV 89501 Printed in the U.S.A.

Authorization status:

unapproved drug other

Summary of Product characteristics

LIDOTHOL- LIDOCAINE HCL, MENTHOL GEL
TERRAIN PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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LIDOTHOL GEL
Lidothol Gel
(Lidocaine 4.5%, Menthol 5%)
Rx only
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
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 con