FDA.reportPublic FDA data

LidoPro Patch

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-02-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:15

Label at a glance#

ProductLidoPro Patch
Active ingredientLIDOCAINE, MENTHOL, METHYL SALICYLATE
Label structure11 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

ad ults and children over 12 years: clean and dry the affected area remove patch from plastic liner and place on the affected area use 1 patch for up to 12 hours place used patch on the liner when not in use re-use the patch up to 2 times. children 12 years or younger: ask a doctor Distributed by Advanced Rx Pharmacy of Tennessee, LLC

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol .5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate .1%

Purpose

OTC - PURPOSE SECTION

Topical Counterirritant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• more than one patch on your bidy at a time or on cuts, irritated, or swollen skin

• on puncture wounds

• for more than one week without consulting a doctor.

When using this product

OTC - WHEN USING SECTION

  • Use only as directed. Read and follow directions and warning on this packaging.
  • Do not apply to wounds or damaged, broken, or irritated skin
  • Avoid contact with the eyes or mucous membranes
  • Do not bandage tightly or apply local heat (such as heating pads) to area of use
  • Do not use at the same time as other topical analgesics
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of injury, such as pain, swelling, or blistering where the product was applied

If pregnant orbreast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

  • clean and dry the affected area
  • remove patch from plastic liner and place on the affected area
  • use 1 patch for up to 12 hours
  • place used patch on the liner when not in use
  • re-use the patch up to 2 times.

children 12 years or younger: ask a doctor

Distributed by
Advanced Rx Pharmacy of Tennessee, LLC

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Vegan Glycerol, Polyacrylate, Aqua. Polysorbate 80

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LidoPro PatchLidoPro Patch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2675022lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % Medicated PatchPSN1
2675024LidoPro Patch 4 % / 0.5 % / 0.1 % Medicated PatchPSN1
2675024lidocaine 0.04 MG/MG / menthol 0.005 MG/MG / methyl salicylate 0.001 MG/MG Medicated Patch [LidoPro Patch]SBD1
2675022lidocaine 0.04 MG/MG / menthol 0.005 MG/MG / methyl salicylate 0.001 MG/MG Medicated PatchSCD1
2675022lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % Medicated PatchSY1
2675024LidoPro Patch (lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % ) 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
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
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
80425-0374-1LidoPro Patch15 in 1 BOXPATCH151
80425-0374-1LidoPro Patch2 in 1 POUCHPATCH21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0374LIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 2 package rows20240302_128d0ba9-bc9d-af16-e063-6394a90af5ef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0374-1EA - Each80425-0374d53c7621-bc05-4e10-807c-840937eb338b12024-04-05
83881-401-02EA - Each83881-40120e2a9b0-fe4b-45f1-a9b5-8f84d6bc947412024-03-12
83881-401-30EA - Each83881-4019e9eafdc-4319-405e-8a30-51cde6f0acea12024-03-12

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80425-037480425-0374-1
83881-401

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
GLYCERINPDC6A3C0OXIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEAdvanced Rx Pharmacy of Tennessee, LLC128d0ba9-bc9d-af16-e063-6394a90af5ef2024-02-29WarningsExact identifier
ndc (package): 80425-0374-1
ndc (product): 80425-0374
ndc11 (package): 80425037401
spl id: 128d3176-c38f-bf72-e063-6394a90aeaf5
spl set id: 128d0ba9-bc9d-af16-e063-6394a90af5ef

Reported adverse events (FAERS/openFDA)#

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