Lidocaine Patch

Manufacturer
Anhui Miao De Tang Pharmaceutical Co., Ltd.
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:01:59

Label at a glance#

ProductLidocaine Patch
Active ingredientMENTHOL, LIDOCAINE
Label structure13 sections

Storage and handling

Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Lidocaine Patch

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%,Menthol 1%

OTC - PURPOSE SECTION

For the temporary relief of palin

INDICATIONS & USAGE SECTION

For the temporary relief of palin, TOPICAL ANESTHETIC

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

more than 1 patch on your body at a time or on cut, irritated or swollen skin

OTC - WHEN USING SECTION

use only as directod. Read and follow all directions and warnings on this label.
rare cases of serious bums have been reported with products of this type
do not apply to wounds or damaged, broken or irritated skin
do not allow contact with the eyes and mucous membranes
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

OTC - STOP USE SECTION

condition worsens
rodness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days
you experience sians ot skin injury, such as pain, swelling, or blistering where the product was applied

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

it swallowed, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:
clean and dry aftecied area
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
carefully remave smaller portion of backing from patch and apply exposed portion of patch to atlected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely applypatch to aitected area
use 2 patch tor up to 24 hours
Children under 12 years of age:consult a doctor

STORAGE AND HANDLING SECTION

Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture.

INACTIVE INGREDIENT SECTION

Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum
Glycerin
Methylparaben
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

labellabel

label2label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN3
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD3
1249758lidocaine 4 % / menthol 1 % 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
81484-901-032024-07-30C16284748780-11e7a6dab-1ac3-a2ce-e063-dadaa90aadf7Lidocaine Patch
81484-901-042024-07-30C16284748780-11e7a6dab-1ac3-a2ce-e063-dadaa90aadf7Lidocaine Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81484-901-01Lidocaine Patch1 in 1 BAGPATCH13
81484-901-02Lidocaine Patch6 in 1 BOXPATCH63
81484-901-03Lidocaine Patch2 in 1 PACKAGEPATCH23
81484-901-04Lidocaine Patch30 in 1 BOXPATCH303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81484-901LIDOCAINE PATCH (LIDOCAINE 4%, MENTHOL 1%) PATCH [ANHUI MIAO DE TANG PHARMACEUTICAL CO., LTD.]34 package rows20231115_054d357c-6a37-5e39-e063-6394a90a5b74.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
81484-90181484-901-01, 81484-901-02, 81484-901-03, 81484-901-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
0a18ac24-4dab-2479-e063-6294a90a52c5054d357c-6a37-5e39-e063-6394a90a5b742023-11-14WarningsExact identifier
spl id: 0a18ac24-4dab-2479-e063-6294a90a52c5
spl set id: 054d357c-6a37-5e39-e063-6394a90a5b74

Reported adverse events (FAERS/openFDA)#

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