Lidocaine with Menthol Patch

Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY | NE2ZEE LIMITED LIABILITY COMPANY | DR SABHARWAL'S WOUND CARE
Effective date
2021-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:15

Label at a glance#

ProductLidocaine with Menthol Patch Pain Releif
Active ingredientLIDOCAINE, MENTHOL
Label structure2 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warning

WARNINGS SECTION

For external use only

Do not Use

OTC - DO NOT USE SECTION

  • more than 1 patch on your body at a time or on cut, 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 all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the 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 or 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

  • condition 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 skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a 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 affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide

Package / Principle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer BoxOuter Box

Package / Inner Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PouchPouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY2

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55629-061-032023-01-30C16284748780-1f386c649-d26b-0266-e053-dadaa90a7c1aLIDOCAINE WITH MENTHOL PATCH PAIN RELIEF- lidocaine 4% and menthol 1% patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-061-01Lidocaine with Menthol PatchPain Releif1 in 1 POUCHPATCH12
55629-061-03Lidocaine with Menthol PatchPain Releif20 in 1 BOXPATCH202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-061LIDOCAINE WITH MENTHOL PATCH PAIN RELEIF (LIDOCAINE 4% AND MENTHOL 1%) PATCH [ONE2ZEE LIMITED LIABILITY COMPANY]2Legacy NDC, 2 package rows20210704_8cc9275c-dfd7-4ba2-8acf-8ae27d2dfdd9.zip

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
55629-06155629-061-01, 55629-061-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
14685a37-dbf3-4e81-8b2e-99a1a07dd8e58cc9275c-dfd7-4ba2-8acf-8ae27d2dfdd92021-01-26WarningsExact identifier
spl id: 14685a37-dbf3-4e81-8b2e-99a1a07dd8e5
spl set id: 8cc9275c-dfd7-4ba2-8acf-8ae27d2dfdd9

Reported adverse events (FAERS/openFDA)#

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