FDA.reportPublic FDA data

Lidocaine Pain Relief Patch

Manufacturer
ShiJiaZhuang MyKang Trading Co., LTD.
Effective date
2024-08-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:17:36

Label at a glance#

ProductLidocaine Pain Relief Patch
Active ingredientLIDOCAINE
Label structure13 sections

Storage and handling

Store at 20-25°C(68-77°F)and protect from moisture.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Lidocaine Pain Relief Patch

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use more than 1 patch at a time on wounds or damagedskin with a heating pad lf you are allergic to any ingredients ofthis product

OTC - WHEN USING SECTION

Avoid contact with the eyes When using this product

OTC - STOP USE SECTION

Stop use and ask a doctor if localized skin reactions occur,such as rash, itching, redness, irritation condition worsens, or if symptoms persist for more than 7 days or clear up and occur againwithin a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a Poison Control Centerright away.
If pregnant or breast-feeding, ask a health professional before use

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:
Clean and dry the affected area
Apply a patch at a time to the affected area; not more than 3 or 4times daily to the affected area
Remove the patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a doctor.

STORAGE AND HANDLING SECTION

Store at 20-25°C(68-77°F)and protect from moisture.

INACTIVE INGREDIENT SECTION

dihydroxyaluminium aminoacetate
disodium EDTA
Methylparaben
polyvinyl alcohol
propylene glycol
sodium carboxymethyl cellulose
sodium polyacrylate
propyl paraben
titanium dioxide
tartaric acid
Glycerin
purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN3
1737778lidocaine 0.04 MG/MG Medicated PatchSCD3
1737778lidocaine 4 % Medicated PatchSY3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84664-001-012026-01-29C16284748780-149896155-a290-586f-e063-e6dba90add90Lidocaine Pain Relief Patch
84664-001-022026-01-29C16284748780-149896155-a290-586f-e063-e6dba90add90Lidocaine Pain Relief Patch
84664-001-032026-01-29C16284748780-149896155-a290-586f-e063-e6dba90add90Lidocaine Pain Relief Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84664-001-01Lidocaine Pain Relief Patch1 in 1 BAGPATCH13
84664-001-01Lidocaine Pain Relief Patch30 in 1 BOXPATCH303
84664-001-02Lidocaine Pain Relief Patch1 in 1 BAGPATCH13
84664-001-02Lidocaine Pain Relief Patch5 in 1 BOXPATCH53
84664-001-03Lidocaine Pain Relief Patch1 in 1 BAGPATCH13
84664-001-03Lidocaine Pain Relief Patch10 in 1 BOXPATCH103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84664-001LIDOCAINE PAIN RELIEF PATCH (LIDOCAINE) PATCH [SHIJIAZHUANG MYKANG TRADING CO., LTD.]36 package rows20240823_2014b858-98da-bb7f-e063-6394a90a85b1.zip

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
84664-00184664-001-01, 84664-001-02, 84664-001-03

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
EDETATE DISODIUM7FLD91C86KIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
LIDOCAINE98PI200987ACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TARTARIC ACIDW4888I119HIACT
PROPYLPARABENZ8IX2SC1OHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

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
204079b9-7c97-6822-e063-6294a90abb372014b858-98da-bb7f-e063-6394a90a85b12024-08-22WarningsExact identifier
spl id: 204079b9-7c97-6822-e063-6294a90abb37
spl set id: 2014b858-98da-bb7f-e063-6394a90a85b1

Reported adverse events (FAERS/openFDA)#

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