Lidothol 4.5 g/100g
LIDOCAINE HCl, MENTHOL · GEL · ASCLEMED USA INC.
Lidothol is a gel containing lidocaine hcl, menthol at 4.5 g/100g, taken cutaneous. Manufactured by ASCLEMED USA INC..
Key Facts
- Brand Name
- Lidothol
- Generic Name
- LIDOCAINE HCl, MENTHOL
- NDC Code (Product)
87063-218- Manufacturer
- ASCLEMED USA INC.
- Strength
- 4.5 g/100g
- Dosage Form
- GEL
- Route
- CUTANEOUS
- Marketing Status
- Marketing Start
- 03/27/2025
Recall History
Preferred Pharmaceuticals, Inc.
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: 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 & Administration
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.
Warnings
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 Li…
Contraindications
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.
Drug Interactions
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
Adverse Reactions
ADVERSE REACTIONS: 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.
Frequently Asked Questions
What is Lidothol used for?
Lidothol contains LIDOCAINE HCl, MENTHOL. It is a gel taken cutaneous. Consult your doctor for specific uses.
Is Lidothol a controlled substance?
Lidothol is not classified as a controlled substance by the DEA.
What is the generic name for Lidothol?
The generic name for Lidothol is LIDOCAINE HCl, MENTHOL. There are 9 other brand versions of LIDOCAINE HCl, MENTHOL.
What is the NDC code for Lidothol 4.5 g/100g?
The NDC (National Drug Code) for Lidothol 4.5 g/100g is 87063-218, listed by ASCLEMED USA INC..