Lidothol ES

Lidothol ES is an FDA-registered drug product whose active ingredient is MENTHOL 5%, LIDOCAINE 4%. It is labelled by Advanced Rx of Tennessee, LLC taken by transdermal and marketed as a human prescription drug product. Identifiers on file: NDC 80425-0561, label effective 20260526. It is one of 2 FDA drug label records sharing the active ingredient MENTHOL 5%, LIDOCAINE 4%. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MENTHOL 5%, LIDOCAINE 4% are most often described in connection with: usage lidothol, assist patients, treatment mild, moderate acute, chronic aches, pain muscle, ligament strains, simple backache. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Lidothol® ES 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® ES to intact skin to cover the most painful area. Apply no more than two systems per day. Each system should not be applied for more than 12 hours in a given 24-hour period. Lidothol® ES may be cut into smaller sizes with scissors prior to the removal of the protective film. Clothing may be worn over the area of application. Smaller treatment areas are recommended for debilitated patients or those with impaired elimination. If irritation or a burning sensation occurs during application, remove the system and do not reapply until the irritation subsides. When Lidothol® ES is used concurrently with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

CONTRAINDICATIONS Lidothol® ES 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.

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® ES are similar in nature to those observed in other amide local 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® ES, the skin at the site of application may develop redness, blisters, bruising, burning sensation, depigmentation, dermatitis, or mild irritation.

FDA lists 2 drug label records with MENTHOL 5%, LIDOCAINE 4% as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Lidothol ES used for?
INDICATIONS AND USAGE Lidothol® ES 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 …

Who makes Lidothol ES?
Advanced Rx of Tennessee, LLC is the labeler of record for Lidothol ES. 2 FDA label records share the active ingredient MENTHOL 5%, LIDOCAINE 4%, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Lidothol ES come in?
administered by transdermal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Lidothol ES prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MENTHOL 5%, LIDOCAINE 4%?
Yes. 2 FDA drug label records list MENTHOL 5%, LIDOCAINE 4% as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Lidothol ES been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.