Lidothol Patch
Patch · Topical
Uses
Lidothol is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact. Other uses may be considered if deemed clinically relevant.
Dosage and administration
Apply Lidothol to intact skin to cover the most painful area. Apply no more than four patches per day. Each patch should not be applied for more than 12 hours in a given 24-‐ hour period. Patches may be cut into smaller sizes with scissors prior to removal of the protective film. Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination. If irritation or a burning sensation occurs during application, remove the patch and do not reapply until the irritation subsides. When Lidothol is used concurrently with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Lidothol may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering
Contraindications
Lidothol 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.
Warnings and precautions
Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Lidothol and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
Warnings
Excessive dosage or short interval between doses can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs. Accidental Exposure in Children Even a used Lidothol patch contains a large amount of Lidocaine. The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Lidothol patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of Lidothol beyond the reach of children, pets and others. (See HANDLING AND DISPOSAL) Excessive Dosing Excessive dosing by applying Lidothol to larger areas for longer than the recommended wearing time could result in increased absorption of Lidocaine and high blood concentrations, leading to serious adverse effects. Lidocaine toxicity could be expected at Lidocaine blood concentrations above 5 µg/mL. The blood concentration of Lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of Lidocaine. With recommended dosing of Lidothol, the average blood concentration is about 0.13 µg/mL, but concentration higher than 0.25 µg/mL have been observed in some patients.
Precautions
Because of the possibility of sedation, patients should be cautioned regarding the use of heavy machinery or automobiles, also any activities made hazardous by decreased alertness. Hepatic Disease Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Lidocaine, because of their inability to metabolize Lidocaine normally. Allergic Reactions Patients allergic to para-‐aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to Lidocaine. However, Lidothol should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Non-intact Skin Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of Lidocaine from increased absorption. Lidothol is only recommended for use on intact skin. Eye Exposure The contact of Lidothol with eyes, although not studied, should be avoided based on the findings of severe eye irritations with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. External Heat Sources Placement of external heat sources, such as heating pads or electric blankets, over patches is not recommended as this has not been evaluated and may increase plasma Lidocaine levels. Drug Interactions: Antiarrhythmic Drugs Lidothol should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics When Lidothol is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A minor metabolite, 2,6-‐xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of Lidothol Mutagenesis Lidocaine is not mutagenic in Salmonella/mammalian microsome test nor clastogenic in chromosome aberration assay with human lymphocytes and mouse micronucleus test. Impairment of Fertility The effect of Lidothol on fertility has not been studied. PREGNANCY: The safety of Lidothol has not been established during pregnancy. There are no well-‐controlled studies in pregnant women. Lidothol should not be used during pregnancy unless absolutely needed. Discuss with physician prior to using Lidothol during pregnancy. NURSING MOTHERS: The effect of Lidothol on the nursing infant has not been evaluated. Lidothol has not been studied in nursing mothers. Caution should be exercised when Lidothol is administered to a nursing mother. PEDIATRIC/GERIATRIC USE: Safety and effectiveness in pediatric and geriatric patients have not been established.
Side effects
The most common adverse reactions occur at the application site, including dermatitis, itching or scaling. These tend to be dose-‐limiting and diminish with time. Serious adverse experiences following the administration of Lidothol are similar in nature to those observed in other amide anesthetic-‐containing agents. These adverse experiences are, in general, dose-‐related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. During or immediately after treatment with Lidothol, the skin at the site of application may develop redness, blisters, bruising, burning sensation, depigmentation, dermatitis, or mild irritation. Allergic Reactions Allergic and anaphylactoid reactions associated with Lidocaine, although rare, can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, consult your doctor.
Drug interactions
Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents Class Nitrates/Nitrites Local Anesthetics Antineoplastic agents Antibiotics Antimalarials Anticonvulsants Other drugs Examples nitroglycerin, nitroprusside, nitric oxide, nitrous oxide benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea dapsone, sulfonamides, nitrofurantoin, para-aminosalicyclic acid chloroquine, primaquine phenytoin, sodium valproate, phenobarbital acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine
Overdosage
There have been no reports of over-‐dosage with Lidothol. Signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.
Description
Lidothol is a prescription topical patch, packaged with 15 medicated patches: 5 per re-sealable pouch, 3 pouches. Lidocaine is present in a 4% concentration (w/w). It is chemically designated as 2-‐(diethylamino)-‐N-‐(2,6-‐ dimethylphenyl) acetamide and has an empirical formula of C14H22N2O. The molecular weight of Lidocaine is 234.34 g/mol. Menthol is present in a 1% concentration (w/w). The chemical name is (1R,2S,5R)-‐2-‐isopropyl-‐5-‐methylcyclohexanol. The empirical formula for Menthol is C10H20O with a molecular weight of 156.27 g/mol. Lidothol (Lidocaine 4% / Menthol 1% Patch) consists of an adhesive hydrogel containing Lidocaine 4% and Menthol 1%, applied to flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin. The size of the patch is 12cm x 8cm. Lidocaine is chemically designated as 2-‐(diethylamino)-‐N-‐(2,6-‐dimethylphenyl), has an octanol: water partition ration of 43 at pH 7.4, and has the following structure: [lidocaine] Menthol is chemically designated as 2-‐Isopropyl-‐5-‐methylcyclohexanol. It contains colorless, hexagonal crystals, usually needle-‐like; fused masses or crystalline powder with a pleasant, peppermint-‐like odor. It has a melting point between 31°C to 36° C. Menthol has the following structure: [menthol] Each adhesive patch contains 76.5mg of Lidocaine and 85mg of Menthol. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, glycerol, methylparaben, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, water
How supplied
Lidothol is supplied in the following dosage form: 15 Patches: 5 per re-‐sealable pouch, 3 pouches NDC 72189-0553-15 Manufactured For: Clinic Pharma Las Vegas, NV 89121
Storage
HANDLING AND DISPOSAL: Wash hands immediately after applying or removing Lidothol. Eye contact with Lidothol should be avoided. Do not store patch outside the sealed envelope. Apply immediately after removal from the protective envelope. Fold used patches so the adhesive side sticks to itself, then safely discard used patches or pieces of cut patches where children and pets cannot access them. Lidothol should be kept out of reach of children. STORAGE: Store at room temperature of 65˚F to 75˚F (18˚C to 24˚C). Keep away from heat or sunlight. Protect from excessive moisture. The product can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.
Label text from the FDA structured product label by Direct_Rx (revised Mar 16, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
Lidothol Patch NDC products (1)
Frequently asked questions
What is Lidothol Patch used for?
Lidothol is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with…
What are the side effects of Lidothol Patch?
The most common adverse reactions occur at the application site, including dermatitis, itching or scaling. These tend to be dose-‐limiting and diminish with time. Serious adverse experiences following the administration of Lidothol are similar in nature to those observed in other amide anesthetic-‐containing agents. These adverse experiences are, in general, dose-‐related and may result from… See the full label for the complete list.
Who makes Lidothol Patch?
Lidothol Patch is listed by 1 labeler in the FDA NDC directory, including Direct_Rx.