Lidotral 5% Gel

Lidotral® 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide.

Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:

Chemical Structure

Mechanism of Action: Lidotral® 5% Gel releases lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. A mild acidic vehicle lowers pH to increase protection against alkaline irritants and to provide a favorable environment for healing.

For the temporary relief of pain.

Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

For external use only. Not for ophthalmic use.

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lidotral® 5% Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.

Teratogenic Effects; Pregnancy Category B. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

Adults and children 12 years of age and older: apply a thin film to the affected areas(s) two or three times per day or as directed by a licensed healthcare practitioner.

Lidotral® 5% Gel is supplied in a 3 oz. (85 g) tube with CRC cap (NDC
59088-204-07).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at 20º-25ºC (68º-77º F) [see USP Controlled Room Temperature]. Protect
from freezing.

Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information call toll-free: 877-921-7873

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