FDA.reportPublic FDA data

Lidocaine Patch

Manufacturer
Hunan En Pu Pharmaceutical Co., Ltd.
Effective date
2024-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:19

Label at a glance#

ProductLidocaine Patch
Active ingredientLIDOCAINE, MENTHOL
Label structure13 sections

Storage and handling

Store in a clean, and dry place outside of direct sunlight.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Lidocaine Patch

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%
Menthol 1%

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

use only as directed
avoid contact with eyes
do not apply to wounds or damaged skin
do not bandage tightly or apply any other heating pads to the affected area

OTC - WHEN USING SECTION

use only as directed
avoid contact with eyes
do not apply to wounds or damaged skin
do not bandage tightly or apply any other heating pads to the affected area

OTC - STOP USE SECTION

if condition worsens
if symptoms clear up and occur again within a few days
if redness and irritation develop
if symptoms persist for more than 7 days, consult a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older
clean and dry affected area
remove backing trom patch and firmly grasp both ends, gently pull backing until it separates up to the middle
slowly apply the patch to the affected area and gently remove any remaining backing from the patch
apply to affected area not more than 3 to 4 times daily

STORAGE AND HANDLING SECTION

Store in a clean, and dry place outside of direct sunlight.

INACTIVE INGREDIENT SECTION

Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum
DMDM hydantoin
Glycerin
PEG-40 Hydrogenated Castor Oil
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Ricinus Communis Seed Oil (Castor)
Silica
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Urea
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN1
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD1
1249758lidocaine 4 % / menthol 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
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
84273-002-01Lidocaine Patch1 in 1 BAGPATCH11
84273-002-01Lidocaine Patch6 in 1 BOXPATCH61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84273-002LIDOCAINE PATCH (LIDOCAINE 4%, MENTHOL 1%) PATCH [HUNAN EN PU PHARMACEUTICAL CO., LTD.]12 package rows20240424_16ab732a-b497-c2e0-e063-6394a90aeb8c.zip

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
84273-00284273-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
TARTARIC ACIDW4888I119HIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
UREA8W8T17847WIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
MENTHOLL7T10EIP3AACTIB
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DMDM HYDANTOINBYR0546TOWIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
16ab732a-b498-c2e0-e063-6394a90aeb8c16ab732a-b497-c2e0-e063-6394a90aeb8c2024-04-22WarningsExact identifier
spl id: 16ab732a-b498-c2e0-e063-6394a90aeb8c
spl set id: 16ab732a-b497-c2e0-e063-6394a90aeb8c

Reported adverse events (FAERS/openFDA)#

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