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Trubrexa lidocaine and capsaicin .00025 g/g; .0475 g/g Patch, 32 patches — NDC 80425-0367-01 package photo

Trubrexa lidocaine and capsaicin .00025 g/g; .0475 g/g Patch, 32 patches

by Advanced Rx Pharmacy of Tennessee, LLC · 8 POUCH in 1 BOX (80425-0367-1) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH
NDC 80425-0367-01
🏷️ FDA NDC (as labeled) 80425-0367-1 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) 80425-0367-1
Product NDC 80425-0367
11-digit billing NDC 80425036701
NCPDP billing unit EA — each (per item)
RxCUI 2667457
UNII S07O44R1ZM, 98PI200987
SPL Set ID 0b28733a-1ac1-5e20-e063-6394a90a41f6
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 2023-11-27
Route TRANSDERMAL
Dosage form PATCH
Substance CAPSAICIN; LIDOCAINE
Why two NDCs? The FDA registers this code as 80425-0367-1 — 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 → 80425-0367-01. 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 Capsaicin and similar agents class.

Drug family (ATC) Capsaicin and similar agents, Other local anesthetics
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 marketedNov 2023
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

📖 About the active ingredient: Capsaicin; Lidocaine MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Capsaicin transdermal patch are used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Read the full MedlinePlus article ↗
🧪 What is this product?

Trubrexa is a transdermal patch containing lidocaine and capsaicin. Lidocaine is a local anesthetic typically used to numb skin and reduce pain sensation in a specific area. Capsaicin, derived from chili peppers, is commonly used in topical products for its warming effect and potential to reduce localized discomfort. This product is marketed without an approved FDA 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 OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • 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 I38ZP9992A
    Magnesium is a mineral element used in medications as a binder and filler to help hold tablet ingredients together and add bulk to the formulation.
  • UNII 9G2MAD7J6W
    Polyacrylic acid is a synthetic polymer used as a binder and thickening agent in medicines. It helps hold tablet ingredients together and can increase the viscosity of liquid or semi-solid formulations.
  • 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.

5 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
Trubrexa .00025 g/g; .0475 g/g 68788-8599-03 Preferred 32 patches — — FDA listed —
Trubrexa Patch ER .00025 g/g; .0475 g/g 72189-0541-11 Direct_Rx 1 patch — — FDA listed —
Trubrexa .00025 g/g; .0475 g/g 76420-0644-32 Asclemed 32 patches — — FDA listed —
Trubrexa .00025 g/g; .0475 g/gthis 80425-0367-01 Advanced 32 patches — — FDA listed —
Trubrexa .00025 g/g; .0475 g/g 83295-4000-01 Strand 32 patches — — FDA listed —
Trubrexa .00025 g/g; .0475 g/g 85509-4000-03 PHOENIX 32 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

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 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
80425-0367-01 You're viewing this 8 POUCH in 1 BOX (80425-0367-1) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH 2023-11-27 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 80425-0367-1, 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: 80425-0367-01, written without dashes as 80425036701. 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 80425-0367-01, the first segment (80425) is the labeler code FDA assigned to Advanced Rx Pharmacy of Tennessee, LLC; the middle segment (0367) 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 Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 44 words ▾

1. INDICATIONS & USAGE Trubrexa TM Transdermal Patch is indicated in adults over the age of 12 years old for the treatment of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.

💊 Dosage Forms and Strengths ~2 min read ▾

2. DOSAGE & ADMINISTRATION

2.1Important Dosage and Administration Instructions Unintended exposure to capsaicin can cause severe irritation of the eyes, mucous membranes, respiratory tract, and skin in healthcare providers and others. Because unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin, when administering Trubrexa TM Transdermal Patch it is important to follow these procedures: Keep Trubrexa TM Transdermal Patch in the sealed pouch until immediately before use. Use Trubrexa TM Transdermal Patch only on dry, intact (unbroken) skin.

During administration, avoid unnecessary contact with any items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets. Immediately after use, clean all areas of skin that had contact with Trubrexa TM Transdermal Patch. Ensure all used and unused pieces Trubrexa TM Transdermal Patch are properly disposed of.

2.2Dosing and Instructions for Use Tear open pouch bag and remove one patch. Place remaining patches back in pouch bag and seal the pouch bag closed. Peel the clear plastic film away and apply Trubrexa TM Transdermal Patch to intact skin to cover the most painful area.

Apply one patch per day for up to 12 hours within a 24 hour period (12 on, 12 off). One single Trubrexa TM Transdermal Patch may be used twice per day. To re-use after first application, place the clear plastic film back on to medicated hydrogel pad.

Clothing may be worn over the area of application. Wash hands with soap and water after handling the patch. If irritation or a burning sensation occurs during application, remove the patch and do not reapply until the irritation subsides.

When Trubrexa TM Transdermal Patch is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

3. DOSAGE FORMS & STRENGTHS Trubrexa TM Transdermal Patch contains 4.75% lidocaine and 0.025% capsaicin. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TM Transdermal Patch logo.

⛔ Contraindications 31 words ▾

4. CONTRAINDICATIONS Trubrexa TM Transdermal Patch 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 ▾

5. WARNINGS, PRECAUTIONS & ADVERSE REACTIONS

5.1Risk of 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; fatigue; or lightheadedness. 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 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 Trubrexa TM Transdermal Patch 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, etc.

A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

5.2Excessive Dosing Excessive dosing by applying Trubrexa TM Transdermal Patch to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and capsaicin and high blood concentrations. Lidocaine toxicity could b e 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 and capsaicin.

5.3Severe Irritation with Unintended Capsaicin Exposure Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin. Eye and Mucous Membrane Exposure Do not apply Trubrexa TM Transdermal Patch to the face, eyes, mouth, nose, or scalp to avoid risk of exposure to eyes or mucous membranes. Accidental exposure to the eyes and mucous membranes can occur from touching Trubrexa TM Transdermal Patch or items exposed to capsaicin, then touching the eyes and mucous membranes.

If irritation of eyes or mucous membranes occurs, remove the affected individual from the vicinity of Trubrexa TM Transdermal Patch and flush eyes and mucous membranes with cool water. Respiratory Tract Exposure Inhalation of airborne capsaicin can result in coughing or sneezing. If irritation of airways occurs, remove the affected individual from the vicinity of Trubrexa TM Transdermal Patch.

Provide supportive medical care if shortness of breath develops. Skin Exposure Thoroughly clean all areas that had contact with Trubrexa TM Transdermal Patch and properly dispose of all patch components.

5.4Application-Associated Pain During or immediately after treatment with Trubrexa TM Transdermal Patch, 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 spo…

🔄 Drug Interactions 134 words ▾

6. DRUG INTERACTIONS Antiarrhythmic Drugs Trubrexa TM Transdermal Patch 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 Trubrexa TM Transdermal Patch is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Drugs That May Cause Methemoglobinemia 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: Nitrates/Nitrites (nitric oxide, nitroglycerin, nitroprusside, nitrous oxide) Local anesthetics (benzocaine, bupivacaine, lidocaine, prilocaine, procaine, 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)

👥 Use in Specific Populations ~1 min read ▾

7. USE IN SPECIFIC POPULATIONS

7.1Pregnancy Trubrexa TM Transdermal Patch has not been studied in pregnancy. Maternal use is not expected to result in fetal exposure. Animal studies have shown no adverse effects when lidocaine and capsaicin are administered and absorbed.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Trubrexa TM Transdermal Patch should only be used during pregnancy if clearly needed or advised by a healthcare professional. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

7.2Lactation Trubrexa TM Transdermal Patch has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk:plasma ration of lidocaine is 0.4. Capsaicin is negligibly absorbed systemically by the mother following topical administration of Trubrexa TM Transdermal Patch.

Caution should be exercised when Trubrexa TM Transdermal Patch is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trubrexa TM Transdermal Patch and any potential adverse effects on the breastfed infant.

7.3Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been studied or established.

7.4Geriatric Use Safety and effectiveness are similar in geriatric patients and younger patients. No dose adjustments are required in geriatric patients.

🆘 Overdosage 124 words ▾

8. OVERDOSAGE Lidocaine overdose from cutaneous absorption is rare but could occur. If there is any suspicion of lidocaine overdose, 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.

There is no specific antidote for overdose with capsaicin. In case of suspected overdose, remove Trubrexa TM Transdermal Patch and gently wash the area with soap and water. Use supportive measures and treat symptoms as clinically warranted.

🧬 Clinical Pharmacology ~1 min read ▾

10. CLINICAL PHARMACOLOGY

10.1Pharmacodynamics Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water. 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 Trubrexa TM Transdermal Patch is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block. Capsaicin is an agonist for the transient receptor potential vanilloid 1 receptor (TRPV1), which is an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin. Topical administration of capsaicin causes an initial enhanced stimulation of the TRPV1-expressing cutaneous nociceptors that may be associated with painful sensations.

This is followed by pain relief thought to be mediated by a reduction in TRPV1-expressing nociceptive nerve endings.

10.2Pharmacokinetics The amount of lidocaine and capsaicin systemically absorbed from Trubrexa TM Transdermal Patch is directly related to both the duration of application and the surface area over which it is applied. Systemic exposure decreases upon removal of Trubrexa TM Transdermal Patch. Lidocaine crosses the placental and blood brain barriers, presumably by passive diffusion.

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. Lidocaine and its metabolites are excreted by the kidneys.

📦 How Supplied / Storage and Handling ~1 min read ▾

12. HOW SUPPLIED / STORAGE & HANDLING

12.1How Supplied Trubrexa TM Transdermal Patch comes in a sealed pouch bag. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, plastic film.

The outer surface of the backing layer is imprinted with the Trubrexa TM Transdermal Patch logo. Trubrexa TM Transdermal Patch is available as a unit box containing 32 patches (8 pouch bags). NDC 83295-4000-1

12.2Storage Store unit box between 68 o -77 o F (20 o -25 o C). Excursions between 15 o -30 o C (59 o -86 o F) are allowed. Keep Trubrexa TM Transdermal Patch in the sealed pouch bags until immediately before use.

12.3Handling and Disposal Unintended exposure to capsaicin can cause severe irritation of eyes, skin, respiratory tract, and mucous membranes. Avoid contact with your eyes, nose, or mouth. Keep used and unused patches out of the reach of children and pets.

Pouch bags are not child resistant. Wash hands with soap and water after handling the patch. If irritation or a burning sensation occurs during application, remove the patch and do not reapply until the irritation subsides.

After use, fold patches so that the adhesive side sticks to itself, then safely discard used patches where children and pets cannot get to them.

📋 Description 108 words ▾

9. DESCRIPTION Trubrexa TM Transdermal Patch is comprised of an adhesive material containing 4.75% lidocaine and 0.025% capsaicin. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric.

The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TM Transdermal Patch logo. 4 patches are included in each pouch bag.

The inactive ingredients include: Arnica, Magnesium, Polyacrylate, Vegan Glycerol, and Water. Trubrexa TM Transdermal Patch is Latex Free, Paraben Free, and Vegan.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80425-0366-01 · Advanced 80425-0368-01 · 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.