FDA.reportPublic FDA data

LidoPro Patch (Lidocaine 4%, Menthol 1%)

Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:29

Label at a glance#

ProductLidoPro Patch (Lidocaine 4%, Menthol 1%)
Active ingredientMENTHOL, LIDOCAINE
Label structure9 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

Adults 18 years and older: clean and dry affected area open pouch and remove one patch remove protective film from patch apply one patch to the affected area of pain and leave in place for 8 to 12 hours

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

External Anesthetic

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on the face or rashes, on wounds or damaged skin
  • in the eyes, mouth, or other mucous membranes
  • on genitals
  • with a heating pad
  • right before or after heart surgery
  • any patch from a pouch that has been opened for 7 or more days
  • in large quantities, particularly over raw surfaces or blistered areas
  • if tamper-evident seal is torn, broken, or missing
  • more than 2 patches per day unless directed by a doctor
  • children under 18 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • allergies to topical products
  • high blood pressure, heart disease, or kidney disease

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
  • The risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and ask doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant of breast-feeding, ask a health professional before use

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose if the used patches by folding sticky ends together.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years and older:

  • clean and dry affected area
  • open pouch and remove one patch
  • remove protective film from patch
  • apply one patch to the affected area of pain and leave in place for 8 to 12 hours

Other information

OTHER SAFETY INFORMATION

  • Some individuals may not experience pain relief until several minutes or hours after applying the patch
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • store at 67-77ºF (19-25ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Kaolin, Methyl parahydroxybenzoate, Partially neutralized Sodium polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, water

Questions?

OTC - QUESTIONS SECTION

Call toll-free (800) 224-2048

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidopro Patch #15Lidopro Patch #15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN1
2675625LidoPro Pain Relieving Patch 4 % / 1 % Medicated PatchPSN1
2675625lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [LidoPro Pain Relieving Patch]SBD1
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD1
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY1
2675625LidoPro Pain Relieving Patch (lidocaine 4 % / menthol 1 % ) Medicated PatchSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0506-1LidoPro Patch (Lidocaine 4%, Menthol 1%)15 mg in 1 POUCHPATCH151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0506LIDOPRO PATCH (LIDOCAINE 4%, MENTHOL 1%) (LIDOCAINE AND MENTHOL PATCH) PATCH [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 1 package rows20250322_30c97646-db06-df84-e063-6394a90a7743.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0506-1EA - Each80425-0506e978e5ac-4853-47c5-8cb9-0273765a407212025-05-14
83881-402-15EA - Each83881-4025d361496-6b99-4115-a5e9-56c801effab012025-03-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80425-050680425-0506-1
83881-402

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
KAOLIN24H4NWX5COIACT
EDETATE SODIUMMP1J8420LUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPANEDIOL5965N8W85TIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
MENTHOLL7T10EIP3AACTIB
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
ndc (product): 83881-402
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHAdvanced Rx of Tennessee, LLC30c97646-db06-df84-e063-6394a90a77432025-03-20WarningsExact identifier
ndc (package): 80425-0506-1
ndc (product): 80425-0506
ndc11 (package): 80425050601
spl id: 30c9764f-80a6-7ffc-e063-6294a90a0c59
spl set id: 30c97646-db06-df84-e063-6394a90a7743

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.