FDA.reportPublic FDA data

1ST MEDX (as PLD) -PATCH WITH LIDOCAINE 4% (72137-555)

Manufacturer
1ST MEDX LLC
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 00:32:51

Label at a glance#

Product1ST MEDXPATCH WITH LIDOCAINE 4%
Active ingredientCAPSAICIN, LIDOCAINE, MENTHOL, METHYL SALICYLATE
Label structure11 sections

Indications and uses

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

Dosage and administration

FOR ADULTS AND CHILDREN 12 YEARS AND OVER. APPLY PATCH TO AFFECTED AREA 1 TO 2 TIMES DAILY OR AS DIRECTED BY PHYSICIAN. CLEAN AND DRY THE AFFECTED AREA. WASH HANDS WITH SOAP AND WATER AFTER APPLYING PATCH. RESEAL POUCH CONTAINING UNUSED PATCHES AFTER USE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

CAPSAICIN O.O25%

LIDOCAINE 4%

MENTHOL 5%

METHYL SALICYLATE 20%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES:

INDICATIONS & USAGE SECTION

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

WARNINGS:

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

  • USE ONLY AS DIRECTED.
  • AVOID CONTACT WITH EYES AND MUCOUS MEMBRANES.
  • DO NOT USE ON WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS, OR ANY OTHER MUCOUS MEMBRANES.
  • DO NOT COVER WITH BANDAGES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, CALL POISON CONTROL

WARNINGS AND PRECAUTIONS SECTION

IF CONTACT DOES OCCUE WITH EYES, RINSE WITH COLD WATER AND CALL A DOCTOR.

CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR BEFORE USE.

  • IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT CONSULT A DOCTOR BEFORE USE.
  • CONSULT YOUR PHYSICIAN: IF PREGNANT OR IF PAIN PERSISTS OR WORSENS.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

FOR ADULTS AND CHILDREN 12 YEARS AND OVER. APPLY PATCH TO AFFECTED AREA 1 TO 2 TIMES DAILY OR AS DIRECTED BY PHYSICIAN. CLEAN AND DRY THE AFFECTED AREA. WASH HANDS WITH SOAP AND WATER AFTER APPLYING PATCH. RESEAL POUCH CONTAINING UNUSED PATCHES AFTER USE.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

STORE BELOW 90°F/32°C

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

GLYCERIN 25%, POLYACRYLIC ACID 5%, PROPYLENE GLYCOL 2%, METHYL SALICYLATE, GLYCERIN, SODIUM POLYACRYLATE, DIHYDROXYALUMINUM AMINOACETATE, ISOPROPYL MYRISTATE, TARTARIC ACID, PROPYLENE GLYCOL, SORBITOL, EDTA2-NA, PROPYL  P-HYDROXYBENZOATE, TWEEN 80, TITANIUM DIOXIDE, EXTRA MEDICAL PURIFIED WATER.

QUESTIONS?

OTC - QUESTIONS SECTION

888-319-6339

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

medx_ndc_72137-555-15_frontmedx_ndc_72137-555-15_front

medx_rear_ndc 72137-555-15_backmedx_rear_ndc 72137-555-15_back

Patch Insert_72137-113-15Patch Insert_72137-113-15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2107511capsaicin 0.025 % / lidocaine 4 % / menthol 5 % / methyl salicylate 20 % Medicated PatchPSN15
2107511capsaicin 0.00025 MG/MG / lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Medicated PatchSCD15
2107511capsaicin 0.025 % / lidocaine 4 % / menthol 5 % / methyl salicylate 20 % Medicated PatchSY15

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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
72137-555-011ST MEDXPATCHWITH LIDOCAINE 4%1 in 1 PATCHPATCH115
72137-555-151ST MEDXPATCHWITH LIDOCAINE 4%10 in 1 POUCHPATCH1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72137-5551ST MEDXPATCH WITH LIDOCAINE 4% (LIDOCAINE, CAPSAICIN, MENTHOL, METHYL SALICYLATE) PATCH [1ST MEDX LLC]15Legacy NDC, 2 package rows20241102_852b3ee7-2644-4faf-8528-b1db9f3d551b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72137-555-01EA - Each72137-55534fff4e8-2d90-4aa6-b72c-a61f798589fd12019-11-12
72137-555-15EA - Each72137-555d06390f6-8a4e-4d7f-a67a-8fe1540cab3012018-08-13

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72137-55572137-555-01, 72137-555-15

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
POLYACRYLIC ACID (450000 MW)KD3S7H73D3IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
TARTARIC ACIDW4888I119HIACT
SORBITOL506T60A25RIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
CAPSAICINS07O44R1ZMACTIB
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
25cae330-0986-52ee-e063-6294a90abf2f852b3ee7-2644-4faf-8528-b1db9f3d551b2024-10-31WarningsExact identifier
spl id: 25cae330-0986-52ee-e063-6294a90abf2f
spl set id: 852b3ee7-2644-4faf-8528-b1db9f3d551b

Reported adverse events (FAERS/openFDA)#

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