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Lidothol ES menthol 5%, lidocaine 4% .04 g/g; .05 g/g System, 15 patches — NDC 80425-0561-01 package photo

Lidothol ES menthol 5%, lidocaine 4% .04 g/g; .05 g/g System, 15 patches

by Advanced Rx of Tennessee, LLC · 15 POUCH in 1 BOX (80425-0561-1) / 1 PATCH in 1 POUCH / 1.38 g in 1 PATCH
NDC 80425-0561-01
🏷️ FDA NDC (as labeled) 80425-0561-1 billing pads the package segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 80425-0561-1
Product NDC 80425-0561
11-digit billing NDC 80425056101
NCPDP billing unit EA — each (per item)
RxCUI 1552201
UNII 98PI200987, L7T10EIP3A
SPL Set ID 49ef3680-e34e-1fe7-e063-6294a90a959f
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-02
Route TRANSDERMAL
Dosage form SYSTEM
Substance LIDOCAINE; MENTHOL
Why two NDCs? The FDA registers this code as 80425-0561-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0561-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAdvanced Rx of Tennessee, LLC
Labeler code80425
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio280 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Lidothol ES is a transdermal patch system containing lidocaine and menthol. Lidocaine is a local anesthetic commonly used to numb skin and reduce pain sensation in a localized area. Menthol is typically used for its cooling sensation and is often included in topical products for comfort. This product is marketed without an FDA-approved application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII 7K68DGG29P
    A synthetic resin made from multiple acrylic compounds. It forms a flexible film coating on tablets or capsules to control how fast the medicine dissolves and releases its active ingredients in your digestive system.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidothol ES Patch .056 g/g; .07 g/g 72189-0674-15 Direct_Rx 15 g — — FDA listed —
Lidothol ES .04 g/g; .05 g/gthis 80425-0561-01 Advanced 15 patches — — FDA listed —
Lidothol ES .04 g/g; .05 g/g 83881-0445-15 Clinic 15 patches — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80425-0561-01 You're viewing this 15 POUCH in 1 BOX (80425-0561-1) / 1 PATCH in 1 POUCH / 1.38 g in 1 PATCH 2026-02-02 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 80425-0561-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 80425-0561-01, written without dashes as 80425056101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 80425-0561-01, the first segment (80425) is the labeler code FDA assigned to Advanced Rx of Tennessee, LLC; the middle segment (0561) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Patient Medication Information
🎯 Indications and Usage 90 words ▾

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 121 words ▾

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 28 words ▾

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.

⚠️ Warnings and Cautions ~3 min read ▾

WARNINGS AND PRECAUTIONS Excessive dosage or short intervals 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 their prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen, or other resuscitative drugs.

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 for some hours after exposure and are characterized by 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® ES 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. Accidental Exposure in Children Even a used Lidothol® ES 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® ES. However, the risk with this formulation has not been evaluated. It is important for patients to store and dispose of Lidothol® ES beyond the reach of children, pets, and others.

(See HANDLING AND DISPOSAL) Excessive Dosing Excessive dosing by applying Lidothol® ES 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 rate of systemic absorption and elimination determines the blood concentration of lidocaine.

Longer duration of application, application of more than the recommended number of systems, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine. With recommended dosing of Lidothol® ES, the average blood concentration is about 0.13 µg/mL, but concentrations higher than 0.25 µg/mL have been observed in some patients. Sedation and Impaired Alertness Because of the possibility of sedation, patients should be cautioned regarding the use of heavy machinery or automobiles, or 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® ES should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.

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.

Non-intact Skin Although not tested, application to br…

🤒 Adverse Reactions 119 words ▾

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.

🔄 Drug Interactions 82 words ▾

DRUG INTERACTIONS Antiarrhythmic Drugs Lidothol® ES 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® ES is used concurrently with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Methemoglobinemia Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: a di table

👥 Use in Specific Populations 81 words ▾

USE IN SPECIFIC POPULATIONS Pregnancy The safety of Lidothol® ES has not been established during pregnancy. There are no well-controlled studies in pregnant women. Discuss with a physician prior to using Lidothol® ES during pregnancy.

Lactation The effect of Lidothol® ES on breastfed infants has not been evaluated. Lidothol® ES has not been studied during lactation. Discuss with a physician prior to using Lidothol® ES while breastfeeding.

Pediatric/Geriatric Use Safety and effectiveness in pediatric and geriatric patients have not been established.

🆘 Overdosage 40 words ▾

OVERDOSAGE There have been no reports of overdosage with Lidothol® ES. 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.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics Menthol works by targeting the κ-opioid receptor on the TRPM8 neuron. The TRPM8 neuron is normally activated at temperatures between 46.4–82.4 °F (8–28 °C). Menthol causes the neuron to fire at temperatures above normal activation, which triggers the characteristic cooling sensation.

Also, because of menthol’s specific targeting of the κ-opioid receptor, it is endowed with analgesic properties. Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses. The penetration of lidocaine into intact skin after application of Lidothol® ES is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.

Pharmacokinetics Absorption The amount of lidocaine and menthol systemically absorbed is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three lidocaine 5% patches were applied over an area of 420 cm² of intact skin on the back of normal volunteers for 12 hours. Blood samples were withdrawn for a determination of lidocaine concentration during the application and for 12 hours after the removal of the patches.

The results are summarized in Table 1: When lidocaine 5% patch is used according to the recommended dosing instructions, only 3 ± 2% of the dose applied is expected to be absorbed. At least 95% (665 mg) of lidocaine will remain in a used patch. The mean peak blood concentration of lidocaine is about 0.13 µg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias).

Repeated application of three days indicated that the lidocaine concentration does not increase with daily use. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1. Figure 1 Mean lidocaine blood concentrations after three consecutive daily applications of three lidocaine patches simultaneously for 12 hours per day in healthy volunteers (n =15).

Distribution When lidocaine is administered intravenously to healthy volunteers, the volume of distribution is 0.7 to

2.7L/kg (mean 1.5 ±

0.6SD, n= 15). At concentrations produced by application of lidocaine patch 5%, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4µg/mL of free base), the plasma protein binding of lidocaine is concentration dependent.

Lidocaine crosses the placental and blood-brain barriers, presumably by passive diffusion. Metabolism It is not known if lidocaine is metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine.

A minor metabolite, 2,6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats. The blood concentration of this metabolite is negligible following application of lidocaine patch 5%. Following intravenous administration, MEGX and GX concentrations in serum range from 11% to 36% and from 5% to 11% of lidocaine concentrations, respectively.

Humans rapidly metabolize menthol primarily in the liver by the microsomes, using the enzyme CYP2A6. Cytochrome P450-mediated oxidation occurs in humans, yielding various alcohol and hydroxy acid derivatives. These are eliminated in the urine unchanged or conjugated with glucuronic acid.

Excretion Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n=15).

The systemic clearance is 0.33 to

0.90L/min (mean 0.64 ±

0.18SD, n=15). Menthol is largely eliminated as glucuronides. In an experiment, 79% of a 1g (Quick, 1928) and…

📦 How Supplied / Storage and Handling 21 words ▾

HOW SUPPLIED Lidothol ES is supplied in the following dosage form: 15 Systems: 1 per pouch, 15 pouches | NDC 80425-0561-01

📦 Storage and Handling 45 words ▾

STORAGE Store at 68–77 °F (20–25 °C); excursions permitted to 59–86 °F (15–30 °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.

📋 Description ~1 min read ▾

Description: Lidothol® ES is a prescription drug-in-adhesive system, packaged with 15 systems: 1 per pouch, 15 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 5% 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® ES consists of a Drug-in-Adhesive System containing lidocaine 4% and menthol 5%, 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 system is 10 cm x 14 cm. Lidocaine is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide, has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure: 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: Each system contains:Lidocaine: 373.5 mg (45 mg per gram adhesive) in an anhydrous base. Menthol: 415 mg (50 mg per gram adhesive) in an anhydrous base.

It also contains the following inactive ingredients: acrylate copolymer PSA adhesives, alpha-tocopherol (vitamin E) lidocaine menthol

💬 Patient Medication Information ~3 min read ▾

Lidocaine 4%, Menthol 5% Drug-in-Adhesive System For External Use Only Do not use: • on the face or rashes, wounds or damaged skin • in the eyes, mouth, or other mucous membranes • on genitals • with a heating pad • right before or after heart surgery • any Lidothol® ES from a pouch that has not been applied immediately after opening the pouch • in large quantities, particularly over raw surfaces or blistered areas • if the pouch is broken or torn • more than 2 Lidothol® ES per day unless directed by a doctor • children under 18 years of age Ask a doctor before use if you have: • allergies to topical or external products • high blood pressure, heart disease, or kidney disease When using this product: • avoid contact with eyes.

If eye contact occurs, rinse thoroughly with water • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask doctor if the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breastfeeding, ask a health professional before use. Do not use during the last 3 months of pregnancy, as it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. If ingested, seek medical help or contact a Poison Control Center 1-800-222-1222 immediately. Dispose of used Lidothol® ES by folding the sticky ends together.

Lidothol® ES Patient Information Before you begin using this medication, read this entire patient information sheet. If you have any questions, please consult your physician or pharmacist. Inform your physician if your condition does not improve or if it worsens.

This information may not include all of the details needed to use Lidothol® ES safely and effectively. Discuss use with your doctor or pharmacist. What is Lidothol® ES?

A drug-in-adhesive system consisting of the external anesthetic lidocaine (4%) and the external analgesic menthol (5%). What is Lidothol® ES used for? Lidothol® ES assists patients in the management of mild to moderate acute pain or mild to moderate aches.

Lidothol® ES is applied to the skin at the specific region experiencing these pain symptoms. The synthesis of lidocaine and menthol is a highly effective combination of pain relievers working to alleviate discomfort while the root cause is being managed and treated by your healthcare providers. What are the possible side effects with Lidothol® ES? • Common: itching or redness of the skin following application • Note: The majority of patients experience no significant adverse events following system application.

Serious side effects are, in general, related to accidental toxicity of medication by applying considerably more than directed by your doctor or pharmacist or by ingesting the contents of Lidothol® ES. • Tell your healthcare provider about all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. • Avoid excessive alcohol usage, since it may increase the potential for Central Nervous System (CNS) effects such as dizziness, confusion, lightheadedness, and orthostatic hypotension.

This is not a complete list of possible side effects. For more information, talk with your doctor or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings Do not use: • on wounds, cuts, damaged or infected skin • on eyes, mouth, genitals, or other mucous membranes • children under 18 years of age • if you are allergic to any of the ingredients in this product Stop use and call your healthcare provider right away if you experience any of the following warning signs or any other unusual symptoms of concern: • if pain worsens • pale, gray, or blue colored skin (cyanosis) • rapid heart rate • shortness of breath • lightheadedness • fatigue • swelling or numbness of the tongue or throat • severe headache or vomiting • dizziness or faintness • changes in vision or spee…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80425-0560-01 · Advanced 80425-0563-01 · Advanced →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.