HomeNDC LookupIngredientsLidocaine 5% › 82347-0505-05
Lidocaine 5% 50 mg/g Patch, 30 patches — NDC 82347-0505-05 package photo

Lidocaine 5% 50 mg/g Patch, 30 patches

by YARAL Pharma Inc. · 30 POUCH in 1 PACKAGE (82347-0505-5) / 1 PATCH in 1 POUCH (82347-0505-4)
NDC 82347-0505-05
🏷️ FDA NDC (as labeled) 82347-0505-5 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 82347-0505-5
Product NDC 82347-0505
11-digit billing NDC 82347050505
NCPDP billing unit EA — each (per item)
RxCUI 1745091
UNII 98PI200987
UPC 0382347050550
Application # ANDA209190
SPL Set ID 08aeb3f5-56ea-4fd7-b151-e6dc65f202da
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-15
Route TOPICAL
Dosage form PATCH
Substance LIDOCAINE
GPI-14 90850060005930
GCN Seq No 043256
GCN 50272
HICL code 010705
Ingredient (HICL) Lidocaine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 72:00.00.00
AHFS class Local Anesthetics
FDB label name LIDOCAINE 5% PATCH
FDB brand name Lidocaine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 82347-0505-5 — 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 → 82347-0505-05. 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

LabelerYARAL Pharma Inc.
Application holderIBSA INSTITUT BIOCHIMIQUE SA
FDA applicationANDA209190 (ANDA)
Labeler code82347
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio18 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

Label name LIDOCAINE 5% PATCH Ingredient Lidocaine
📖 What it is MedlinePlus · NLM

Prescription lidocaine transdermal (Dermalid, Lidoderm, Ztildo) is used to relieve the pain of post-herpetic neuralgia (PHN; burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nonprescription (over-the-counter) lidocaine (Absorbine Jr, Aspercreme, Lidocare, Salonpas, others) is also available to relieve minor pain in shoulders, arms, neck and legs in adults and children 12 years of age and older. Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
  • Can I use a lidocaine patch and a lidocaine cream at the same time?
  • No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
  • Can I put a heating pad on the area where I applied a lidocaine patch?
📖 Read our full Lidocaine guide →
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.

From the label’s inactive-ingredient sectionInactive Ingredient Aloe Barbadensis Leaf Juice Arctium Lappa Root Extract Arnica Montana Flower Extract Boswellia Carterii resin Extract Calendula Officinalis Extract Camellia Sinensis Leaf Extract Camphor Carbomer FD & C Blue #1 FD & C Yellow #5 Glycerin Isopropyl Alcohol Isopropyl Myristate llex Paraguariensis Leaf Extract Melissa Officinalis Leaf Extract Phenoxyethanol Silicon dioxide Tocopheryl Acetate Triethanolamine Water

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eaPer package
Retail pharmacies payNADAC · weekly $1.915 $57.45 / 30 patch
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 · Q2 2026 $2.72 $81.65 / 30 patch
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2024 Feb 2024 $1.928 $1.861
▲ Up 3% over the last 3 months.
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 5% 50 mg/gthis 82347-0505-05 YARAL 30 patches $1.915 AB FDA listed
Lidocaine 50 mg/g 00591-2679-30 Actavis 30 pouches $2.031 AB Availability likely +6%
Lidocaine 50 mg/g 00591-3525-30 Actavis 30 pouches $2.031 AB Availability likely +6%
Lidocaine 50 mg/g 00603-1880-16 Par 30 pouches $2.031 AB Availability likely +6%
Lidocan IV 50 mg/g 59088-0910-54 PURETEK 30 pouches $2.031 AB Availability likely +6%
Lidocaine 700 mg 65162-0791-08 Amneal 30 patches $2.031 AB Availability likely +6%
Tridacaine XL 50 mg/g 73352-0845-30 Trifluent 30 packets $2.031 AB Availability likely +6%
Lidocaine 700 mg 42291-0477-30 AvKARE 30 patches AB FDA listed
Lidocaine 50 mg/g 42291-0495-30 AVKARE 30 pouches AB FDA listed
Lidocaine 50 mg/g 50090-1359-02 A-S 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 50090-7857-02 A-S 30 pouches AB FDA listed
Lidocaine 700 mg 50090-7894-02 A-S 30 patches AB FDA listed
Lidocaine 50 mg/g 51407-0827-30 Golden 30 pouches AB FDA listed
Lidocaine 50 mg/g 55154-2665-05 Cardinal 5 pouches AB FDA listed
Lidocaine 50 mg/g 55154-7228-05 Cardinal 5 patches AB FDA listed
Lidocaine 50 mg/g 55700-0142-30 Quality 30 pouches AB FDA listed
LidoPure Patch 59088-0712-00 PureTek 1 kit FDA listed
Lidoxryl 59088-0722-00 PureTek 1 kit FDA listed
Lidocan VII 50 mg/g 59088-0900-54 PURETEK 30 pouches AB FDA listed
Lidocan 700 mg 59088-0905-54 PURETEK 30 patches AB FDA listed
Lidocan III 50 mg/g 59088-0907-54 PURETEK 30 patches AB FDA listed
Lidocan V 50 mg/g 59088-0909-54 PURETEK 30 pouches AB FDA listed
Lidocan VI 50 mg/g 59088-0911-54 PURETEK 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 60760-0657-05 St. 5 patches AB FDA listed
Lidocaine 50 mg/g 60760-0880-05 St. 5 pouches AB FDA listed
Lidocaine 50 mg/g 61919-0588-30 DIRECT 1 g AB FDA listed
Lidoderm 700 mg 61959-0001-30 TPU 30 patches AB FDA listed
Lidocaine 50 mg/g 63629-5094-01 Bryant 30 pouches AB FDA listed
Lidocaine 50 mg/g 63629-7059-01 Bryant 30 pouches AB FDA listed
Lidocaine 50 mg/g 63629-8755-01 Bryant 30 pouches AB FDA listed
Lidocaine 5% 700 mg 68071-3620-03 NuCare 30 patches AB FDA listed
Lidocaine 50 mg/g 68788-7159-03 Preferred 30 pouches AB FDA listed
Lidocaine 700 mg 68788-8344-03 Preferred 30 patches AB FDA listed
Lidocaine 50 mg 70518-0566-00 REMEDYREPACK 30 patches AB FDA listed
Lidocaine 5% 50 mg/g 70518-4487-00 REMEDYREPACK 30 pouches AB FDA listed
Lidocaine 50 mg/g 70518-4502-00 REMEDYREPACK 30 pouches AB FDA listed
Lidocaine 50 mg/g 71335-1934-01 Bryant 30 pouches AB FDA listed
Lidocaine 700 mg 71335-1971-01 Bryant 30 patches AB FDA listed
Lidocaine 700 mg 72162-2085-03 Bryant 30 patches AB FDA listed
Lidocaine Patch 700 mg 72189-0387-30 Direct_Rx 30 patches AB FDA listed
Tridacaine III 50 mg/g 73352-0835-15 Trifluent 15 packets AB FDA listed
Lidocaine 50 mg/g 76420-0037-30 Asclemed 30 pouches AB FDA listed
Lidocaine 50 mg/g 76420-0887-30 Asclemed 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 76420-0899-30 Asclemed 30 pouches AB FDA listed
Lidocaine 700 mg 80425-0325-01 Advanced 30 patches AB FDA listed
Lidocaine 50 mg/g 80425-0404-01 Advanced 30 pouches AB FDA listed
Lidocaine 5% Patch 700 mg 82461-0611-15 Medcore 15 patches AB FDA listed
Lidocaine 50 mg/g 85509-2880-03 PHOENIX 30 pouches AB FDA listed
Lidocaine 50 mg/g 85766-0169-30 Sportpharm 30 pouches AB FDA listed
Lidocaine 700 mg 85766-0170-30 Sportpharm 30 patches AB FDA listed
Lidox 5 Patch 50 mg/g 87234-0505-03 Injecta 30 pouches AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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
82347-0505-05 You're viewing this 30 POUCH in 1 PACKAGE (82347-0505-5) / 1 PATCH in 1 POUCH (82347-0505-4) 2023-06-15 Active

📄 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 24 words

INDICATIONS AND USAGE Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

⏱️ Dosage and Administration 157 words

DOSAGE AND ADMINISTRATION Apply lidocaine patch 5% to intact skin to cover the most painful area. Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24-hour period. Patches may be cut into smaller sizes with scissors prior to removal of the release liner (see HANDLING AND DISPOSAL).

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(es) and do not reapply until the irritation subsides.

When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Lidocaine patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming, or showering.

Direction: Apply to affectered area not more that 3 to 4 times daily.

Contraindications 29 words

CONTRAINDICATIONS Lidocaine patch 5% 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 ~2 min read

WARNINGS Risk of 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 of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or 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 lidocaine patch 5% and any other oxidizing agents.

Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Accidental Exposure in Children Even a used lidocaine patch 5% contains a large amount of lidocaine (at least 665 mg).

The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch 5%, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of lidocaine patch 5% out of the reach of children, pets, and others (see HANDLING AND DISPOSAL). Excessive Dosing Excessive dosing by applying lidocaine patch 5% to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions).

Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/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 lidocaine patch 5%, the average peak blood concentration is about 0.13 mcg/mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.

For external use only.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Application Site Reactions During or immediately after treatment with lidocaine patch 5%, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. 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, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Other Adverse Events Due to the nature and limitation of spontaneous reports in postmarketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of lidocaine patch 5% are unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold, or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness.

Cardiovascular manifestations may include bradycardia, hypotension, and cardiovascular collapse leading to arrest.

🔄 Drug Interactions 148 words

Drug Interactions Antiarrhythmic Drugs Lidocaine patch 5% should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Drugs That May Cause Methemoglobinemia When Used with Lidocaine Patch 5% Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine

🤰 Pregnancy 78 words

Pregnancy Teratogenic Effects Pregnancy Category B. Lidocaine patch 5% has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine patch 5% should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words

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

🆘 Overdosage 153 words

OVERDOSAGE Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions), drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment.

Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics. The oral LD 50 of lidocaine HCl is 459 (346 to 773) mg/kg (as the salt) in non-fasted female rats and 214 (159 to 324) mg/kg (as the salt) in fasted female rats, which are equivalent to roughly 4000 mg and 2000 mg, respectively, in a 60 to 70 kg man based on the equivalent surface area dosage conversion factors between species.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Pharmacodynamics 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 a lidocaine patch 5% 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 systemically absorbed from lidocaine patch 5% is directly related to both the duration of application and the surface area over which it is applied.

In a pharmacokinetic study, three lidocaine patches were applied over an area of 420 cm 2 of intact skin on the back of normal volunteers for 12 hours. Blood samples were withdrawn for determination of lidocaine concentration during the application and for 12 hours after removal of patches. The results are summarized in Table 1.

Table 1 Absorption of lidocaine from Lidocaine Patch 5% Normal volunteers (n=15, 12-hour wearing time) Lidocaine Patch 5% Application Site Area (cm 2 ) Dose Absorbed (mg) C max (mcg/mL) T max (hr) 3 patches (2100 mg) Back 420 64 ± 32 0.13 ± 0.06 11 hr When lidocaine patch 5% 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 mcg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias).

Repeated application of three patches simultaneously for 12 hours (recommended maximum daily dose), once per day for 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 4 mcg/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.

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 the 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). graphs

📦 How Supplied / Storage and Handling 72 words

HOW SUPPLIED Lidocaine patch 5% is available as the following: Carton of 30 patches...........................................................................................NDC 82347-0505-5 (packaged in individual child-resistant envelopes) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. For more information, call YARAL Pharma, Inc. at 1-866-218-9009. Marketed by: YARAL Pharma, Inc.

Pasippany, NJ 07054, USA Manufactured by: Altergon Italia Srl Zona Industriale ASI, Morra de Sanctis Avellino, 83040, Italy Revised 12/2022

🧪 Active Ingredient 6 words

Menthol Gel Active Ingredient Menthol 6%

🧪 Inactive Ingredients 57 words

Inactive Ingredient Aloe Barbadensis Leaf Juice Arctium Lappa Root Extract Arnica Montana Flower Extract Boswellia Carterii resin Extract Calendula Officinalis Extract Camellia Sinensis Leaf Extract Camphor Carbomer FD & C Blue #1 FD & C Yellow #5 Glycerin Isopropyl Alcohol Isopropyl Myristate llex Paraguariensis Leaf Extract Melissa Officinalis Leaf Extract Phenoxyethanol Silicon dioxide Tocopheryl Acetate Triethanolamine Water

🎯 Purpose 3 words

Menthol 6%------------------------------------------------------------Topical Analgesic

📋 Description 127 words

DESCRIPTION Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm.

Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure: Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben. molecule

💬 Information for Patients 64 words

Information for Patients Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.