FDA.reportPublic FDA data

Maximum Strength 4% Lidocaine Patch

Manufacturer
InterMed Laboratories Private Limited
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:54

Label at a glance#

ProductMaximum Strength 4% Lidocaine Patch Leader
Active ingredientLIDOCAINE
Label structure12 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adults and children over 2 years: clean and dry affected area free of lotions, ointments and creams. carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discar patch after single use. children 2 years or younger: ask a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

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
  • for more than one week without consulting a doctor
  • over raw surfaces or blistered areas
  • if pouch is damaged or opened

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

Stop Use and Ask a Doctor if

OTC - STOP USE SECTION

  • condition worsens
  • skin irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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 2 years:

  • clean and dry affected area free of lotions, ointments and creams.
  • carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area.
  • Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discar patch after single use.

children 2 years or younger:ask a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, methyl paraben, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, tartaric acid, titanium dioxide, water

Bulk Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55

66

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % 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
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
71811-007-05Maximum Strength 4% Lidocaine PatchLeader5 in 1 CARTONPATCH52
71811-007-05Maximum Strength 4% Lidocaine PatchLeader1 in 1 POUCHPATCH12
71811-007-06Maximum Strength 4% Lidocaine PatchLeader1 in 1 POUCHPATCH12
71811-007-06Maximum Strength 4% Lidocaine PatchLeader6 in 1 CARTONPATCH62

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71811-00771811-007-05, 71811-007-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength 4% Lidocaine Patch LeaderLIDOCAINEInterMed Laboratories Private Limited42f06914-c8b8-ea9c-e063-6294a90a79e62025-11-19WarningsExact identifier
ndc (package): 71811-007-05
ndc (package): 71811-007-06
ndc (product): 71811-007
ndc11 (package): 71811000706
ndc11 (package): 71811000705
spl id: 43f3ffc7-21c5-883f-e063-6394a90a0565
spl set id: 42f06914-c8b8-ea9c-e063-6294a90a79e6

Reported adverse events (FAERS/openFDA)#

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