Home › NDC Lookup › Ingredients › Lidocaine And Menthol › 80425-0385-01
LIDOTHOL lidocaine and menthol 1 mg/100mg; 4 mg/100mg Patch — NDC 80425-0385-01 package photo

LIDOTHOL lidocaine and menthol 1 mg/100mg; 4 mg/100mg Patch

by Advanced Rx Pharmacy of Tennessee, LLC · 3 POUCH in 1 BOX (80425-0385-1) / 5 PATCH in 1 POUCH / 8500 mg in 1 PATCH
NDC 80425-0385-01
🏷️ FDA NDC (as labeled) 80425-0385-1 billing pads the package segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Aug 27, 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) 80425-0385-1
Product NDC 80425-0385
11-digit billing NDC 80425038501
NCPDP billing unit EA — each (per item)
RxCUI 1249758
UNII L7T10EIP3A, 98PI200987
SPL Set ID 181f0806-dab7-410c-e063-6294a90ac09c
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 2024-05-10
Route TOPICAL
Dosage form PATCH
Substance MENTHOL; LIDOCAINE
Why two NDCs? The FDA registers this code as 80425-0385-1 — 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 → 80425-0385-01. 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 Pharmacy of Tennessee, LLC
Labeler code80425
First marketedMay 2024
Product typeHuman Prescription Drug
Portfolio254 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 is a topical patch containing lidocaine and menthol. Lidocaine is a local anesthetic typically used to numb or reduce sensation in the area where it is applied. Menthol is commonly included in topical products for its cooling sensation. This is an unapproved drug product 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 DO250MG0W6
    A mineral compound containing aluminum that acts as an antacid and buffering agent. It helps neutralize stomach acid and is used as a pH buffer to stabilize the medicine's formulation.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 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
Lidocaine Menthol Pain Relief 4 g/100g; 1 g/100g 46122-0574-21 Amerisource 5 patches $0.945 — Availability likely —
Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 70000-0558-01 Cardinal 5 patches $0.945 — Availability likely —
Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 00363-0914-05 Walgreen 5 patches — — FDA listed —
Walgreens Cool N Heat Patch 10 mg/g; 40 mg/g 00363-6670-05 Walgreen 5 patches — — FDA listed —
Walgreens Kinesiology Pain Relief 4 mg/100mg; 1 mg/100mg 00363-9657-00 Walgreen 20 applicators — — FDA listed —
Maximum Strenght Lidocaine plus Menthol Pain Relief Patch 1 g/100g; 4 g/100g 11822-6514-01 Rite 5 patches — — FDA listed —
Albertson Lidocaine, Menthol Pain Relief Medicated Patch 4 g/100g; 1 g/100g 21130-0961-05 Safeway 5 g — — FDA listed —
Icy Hot with Lidocaine 240 mg/1; 60 mg 41167-1720-01 Chattem, 5 patches — — FDA listed —
Maximun Strength Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 41250-0841-05 Meijer 5 patches — — FDA listed —
CVS Cold and Hot Pain Relief 10 mg/g; 40 mg/g 51316-0274-05 CVS 5 patches — — FDA listed —
Lidospot patch .01 g/g; .04 g/g 51452-0172-05 Fabrication 5 patches — — FDA listed —
Point Relief LidoSpot with Menthol 4 g/100g; 1 g/100g 51452-0912-05 Fabrication 5 patches — — FDA listed —
MAXIMUM STRENGTH Lidocaine Plus Menthol 4 g/100g; 1 g/100g 55301-0912-05 ARMY 5 patches — — FDA listed —
Biofreeze Ultraflex Plus .04 g/g; .01 g/g 59316-0898-04 Reckitt 4 patches — — FDA listed —
CVS Health Lidocaine Pain Relief Plus Menthol 240 mg/1; 60 mg 66902-0220-05 Natural 5 patches — — FDA listed —
Pure-Aid 240 mg/1; 60 mg 67510-0284-01 Kareway 1 patch — — FDA listed —
Soundbody 40 mg/1; 10 mg 67510-0636-01 Kareway 1 patch — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 68788-8879-01 Preferred 15 mg — — FDA listed —
Lidocaine Pain Relief Patch 1 g/100g; 4 g/100g 69159-0920-05 Foshan 5 patches — — FDA listed —
HealthWise Lidocaine Plus Menthol Patch 4 g/100g; 1 g/100g 71101-0062-05 Veridian 5 g — — FDA listed —
HealthWise Lidocaine and Menthol 4 g/100g; 1 g/100g 71101-0082-15 Veridian 15 g — — FDA listed —
TheraCare 2X Medicated Pain Relief 1 g/100g; 4 g/100g 71101-0127-01 Veridian 5 patches — — FDA listed —
TheraCare Pain Relief Medicated 4 g/100g; 1 g/100g 71101-0912-05 Veridian 5 g — — FDA listed —
HealthWise Lidocaine and Menthol Pain Relief 4 g/100g; 1 g/100g 71101-0914-05 Veridian 5 g — — FDA listed —
Lidozen 40 mg/g; 10 mg/g 71205-0348-05 Proficient 5 patches — — FDA listed —
Lidozen Patch 40 mg/g; 10 mg/g 71205-0745-05 Proficient 5 patches — — FDA listed —
Dr Sabharwals 224 mg/1; 56 mg 71318-0115-15 Dr. 15 patches — — FDA listed —
AsperFlex MAX 240 mg/1; 60 mg 71399-4453-05 Akron 5 patches — — FDA listed —
Lidozen Patch 40 mg/g; 10 mg/g 71574-0905-05 Village 5 patches — — FDA listed —
Hot and Cold Lidocaine with Menthol Patch Pain Relief 240 mg/1; 60 mg 71811-0002-05 InterMed 500 patches — — FDA listed —
Lidothol Patch 1 mg/100mg; 4 mg/100mg 72189-0553-15 Direct_Rx 1 patch — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0172-05 Shanghai 5 patches — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0174-20 Shanghai 20 patches — — FDA listed —
Pain Relief .01 g/g; .04 g/g 73557-0175-20 Shanghai 20 patches — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0176-18 Shanghai 18 patches — — FDA listed —
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee 40 mg/g; 10 mg/g 75568-0013-01 Planet 4.56 g — — FDA listed —
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border 40 mg/g; 10 mg/g 75568-0014-01 Planet 9.1 g — — FDA listed —
Careland Plantar Fasciitis Hydrogel Pain Patches 40 mg/g; 10 mg/g 75568-0017-01 Planet 8 pouches — — FDA listed —
Careland Hydrogel Pain Relief Patches 40 mg/g; 10 mg/g 75568-0022-01 Planet 8 patches — — FDA listed —
TopCare Pain Relief Patch 4 g/100g; 1 g/100g 76162-0007-05 Topco 5 pouches — — FDA listed —
Zylotrol Maximum Pain .03 g/3g; .12 g/3g 76420-0581-15 Asclemed 15 patches — — FDA listed —
Equate Lidocaine and Menthol Paraben Free 1 g/100g; 4 g/100g 79903-0030-05 Walmart 5 pouches — — FDA listed —
Equate Lidocaine Cool and Heat 1 g/100g; 4 g/100g 79903-0038-05 Walmart 5 pouches — — FDA listed —
Lidothol 1 mg/100mg; 4 mg/100mgthis 80425-0385-01 Advanced 15 patches — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 80425-0506-01 Advanced 15 mg — — FDA listed —
Lidocaine and Menthol .04 g/g; .01 g/g 80425-0560-01 Advanced 30 patches — — FDA listed —
LidoPro .04 g/g; .01 g/g 80425-0582-01 Advanced 30 patches — — FDA listed —
LidoReal Patch 4 mg/1; 1 mg 81877-0725-15 FORREAL 15 patches — — FDA listed —
Zylotrol Maximum Pain .03 g/3g; .12 g/3g 81902-0104-15 Whitestone 15 patches — — FDA listed —
Lidosync 4 g/1; 1 g 82944-0104-10 Ion 10 patches — — FDA listed —
Pain Relief Gel-Patch .12 g/12g; .48 g/12g 83016-0171-07 R 7 packets — — FDA listed —
AUVON Lidocaine Menthol Pain Relief Patch 100 mg/1; 400 mg 83391-0008-01 SHENZHEN 1 patch — — FDA listed —
Collajoint Lidocaine Pain Relief Gel Patch 1 g/1001; 4 g/1001 83559-0012-01 Henan 12 patches — — FDA listed —
Rapid Relief 1 g/100g; 4 g/100g 83569-0014-01 RAPID 100 g — — FDA listed —
Rapid Relief 4 g/100g; 1 g/100g 83569-0016-06 RAPID 1 pouch — — FDA listed —
Pain Relief Gel-Patch .04 g/g; .01 g/g 83602-0172-15 Guangzhou 15 patches — — FDA listed —
Foot Pain Relief Gel-Patch .01 g/g; .04 g/g 83602-0174-15 Guangzhou 15 patches — — FDA listed —
Lidocaine Pain Relief Gel-Patch .01 g/g; .04 g/g 83602-0175-11 Guangzhou 11 patches — — FDA listed —
Knee Pain Relief Gel-Patch .04 g/g; .01 g/g 83602-0178-12 Guangzhou 12 patches — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 83881-0402-05 Clinic 5 mg — — FDA listed —
LidoPro .04 g/g; .01 g/g 83881-0403-01 Clinic 1 patch — — FDA listed —
Lidothol 4 mg/100mg; 1 mg/100mg 83881-0441-15 Clinic 15 patches — — Discontinued —
Plantar Fasciitis Pain Relief Gel-Patch 1 g/100g; 4 g/100g 84165-0007-01 Guangzhou 6 g — — FDA listed —
Chinese Red Tiger Lidocaine Patches .04 g/g; .01 g/g 84165-0010-01 Guangzhou 12 g — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 84165-0104-01 Guangzhou 12 g — — FDA listed —
Perform Leo Extensive Pain Relief 4 g/100g; 1 g/100g 84410-0001-01 PERFORM 5 patches — — FDA listed —
Lidocaine .4 g/10g; .1 g/10g 84722-3041-00 Vive 5 g — — FDA listed —
Lidocaine .1 g/10g; .4 g/10g 84722-3072-00 Vive 5 g — — FDA listed —
4% lidocaine plus 1% menthol Pain Relief Patch 1 g/100g; 4 g/100g 85323-0003-00 Xuzhou 5 patches — — FDA listed —
4% Lidocaine Patches 4 g/100g; 1 g/100g 85593-0010-01 Guangzhou 15 patches — — Discontinued —
NeuroCool Patches 4 mg/100mg; 1 mg/100mg 85622-0500-15 Blue 15 pouches — — FDA listed —
Plantar Pain Relief Patch .01 g/g; .04 g/g 87518-0174-15 Guangzhou 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
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
80425-0385-01 You're viewing this 3 POUCH in 1 BOX (80425-0385-1) / 5 PATCH in 1 POUCH / 8500 mg in 1 PATCH 2024-05-10 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 80425-0385-1, 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: 80425-0385-01, written without dashes as 80425038501. 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 80425-0385-01, the first segment (80425) is the labeler code FDA assigned to Advanced Rx Pharmacy of Tennessee, LLC; the middle segment (0385) 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 Pharmacy of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx Pharmacy 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 ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Patient Medication Information
🎯 Indications and Usage 90 words ▾

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 and Administration 139 words ▾

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 27 words ▾

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 Cautions 177 words ▾

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 ~1 min read ▾

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.

🤒 Adverse Reactions 149 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 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 74 words ▾

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 39 words ▾

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.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY: Lidocaine is a topical anesthetic and stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Menthol has local anesthetic and counterirritant qualities. It also acts as a weak kappa (ĸ) opioid receptor agonist.

Menthol chemically triggers the cold-­‐sensitive TRPM-­‐8 receptors in the skin, which are responsible for the well-­‐documented cooling sensation that occurs when applied to the skin. Menthol’s analgesic properties are not fully understood; however, they are mediated through a selective activation of ĸ-­‐opioid receptors. Menthol also blocks voltage-­‐sensitive sodium channels, reducing neural activity that may stimulate muscle tissue.

Pharmacodynamics Menthol works by targeting the k-­‐opiod receptor on the TRPM8 neuron. The TRPM8 neuron is normally activated at temperatures between (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 k-­‐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 patch 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 removal of patches.

The results are summarized in table 1. 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.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. Mean peak blood concentration of Lidocaine is about 0.13 µg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias). Figure 1 Mean Lidocaine blood concentrations after three consecutive daily applications of three Lidocaine 5% 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 4 µg/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 menoethylglycinexylidie (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…

📦 How Supplied / Storage and Handling 34 words ▾

Lidothol is supplied in the following dosage form: 15 Patches: 5 per re-­‐sealable pouch, 3 pouches NDC 80425-0385-01 Manufactured For: Clinic Pharma Las Vegas, NV 89121 Distributed by: Advanced Rx Pharmacy of Tennessee, LLC

📦 Storage and Handling 113 words ▾

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.

📋 Description 219 words ▾

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: 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 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 lidocaine menthol

💬 Patient Medication Information ~3 min read ▾

Lidothol (Lidocaine 4% / Menthol 1% Patch) For Topical Use Only Do not use: On the face or rashes On wounds, damaged, or infected skin In the eyes, mouth or other mucous membranes On genitals With a heating pad Ask a doctor before use if: You are allergic to topical products or any ingredients in this product You are pregnant or breast feeding You are under age 18 When using this product: Wash hands after applying or removing patch Avoid contact with eyes If eye contact occurs, rinse thoroughly with water Stop use and consult your physician if: Rash, irritation, or itching develops Condition worsens Keep out of reach of children Lidothol 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 safely and effectively. Discuss use with your doctor or pharmacist. What is Lidothol?

A topical pain relief patch consisting of the local anesthetic Lidocaine (4%) and the topical analgesic Menthol (1%). What is Lidothol used for? The patch assists patients in the management of mild to moderate acute pain or mild to moderate aches.

Lidothol 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. DO NOT USE: If you are allergic to any of the ingredients in this product On wounds or damaged skin With a heating pad If you are pregnant, planning to become pregnant, or breastfeeding What are the possible side effects with Lidothol?

Common: itching or redness of the skin following application NOTE: The majority of patients experience no significant adverse events following patch 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 the patch. 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 the possible side effects.

For more information, talk with your doctor or pharmacist. You may report side effects to FDA at 1-­‐800-­FDA-­1088 or www.fda.gov/medwatch KEEP OUT OF REACH OF CHILDREN Rx ONLY DIRECTIONS FOR USE Adults and children 12 years and over: Apply 1 to 2 patches to the affected area of intact skin. Lidothol should be removed after 12 hours of continuous use and remain off for at least 12 hours.

Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors. Safely discard the remaining unused pieces of cut patches where children and pets cannot reach.

Remove the transparent protective film (clear plastic barrier) before application of patches to the skin. Apply immediately after removing the protective film. Apply 1 patch to the affected area so that the patch covers all or most of the painful area.

Remove patch if irritation occurs. Children under 12 years of age: Consult a doctor WARNINGS Do not use: On wounds, cuts, damaged or infected skin On eyes, mouth, genitals, or other mucous membranes 2. Consult physician for children under 12 years of age 3.

Stop and consult your prescriber if pain worsens Call your healthcare provider right away if you experience any of the following warning signs or any other unusual symptoms of concern: Shortness of breath Swelling or numbness of the tongue or throat Severe headache or vomi…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80425-0384-01 · Advanced 80425-0386-01 · 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.