Lidocaine Patch

Manufacturer
Anhui Miao De Tang Pharmaceutical Co., Ltd.
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:04

Label at a glance#

ProductLidocaine Patch
Active ingredientMENTHOL, LIDOCAINE
Label structure13 sections

Dosage and administration

Adults and children over 12 years: • Wash and dry the affected area. • Remove backing from patch by firmty grasping both ends and gently pulling until backing separates in the middle • Carefully remove smaller portion of back,ng from patch and apply exposed portion of patch to a什ected area • Once exposed portion of patch is po奾oned.carefully remove remaining backing tocomplelely apply patch to affected area. • Car...

Storage and handling

Store at room temperature - do not exceed 86'F, 30'C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LIDOCAINE PATCH

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE 4% Purpose:Topical Analgesic

MENTHOL 1% Purpose: External Analges

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic, External Analges, LIDOCAINE PATCH

Use

INDICATIONS & USAGE SECTION

LIDOCAINE PATCH to help Temporarily relteves minor pain

Warnings

WARNINGS SECTION

For external use only. Flammable.

Do not use

OTC - DO NOT USE SECTION

• More than one patch on your body at a time or on cut, irritated or swollen skin
• On open or puncture wounds

• For more than one week without consulling a doctor.

OTC - WHEN USING SECTION


• Use only as directed. Read and邸ow all directions and warnings on this label.
• Rare cases of serious burns have been reported with products of this type.
• Oo not apply to wou心s 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.
• Dispose of used patch in manner that always keeps producl away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:


• Wash and dry the affected area.
• Remove backing from patch by firmty grasping both ends and gently pulling until backing separates in the middle


• Carefully remove smaller portion of back,ng from patch and apply exposed portion of patch to a什ected area
• Once exposed portion of patch is po奾oned.carefully remove remaining backing tocomplelely apply patch to affected area.
• Carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
• Use only 1 patch for a maximum of 24 hours.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature - do not exceed 86'F, 30'C

Inactive ingredients

INACTIVE INGREDIENT SECTION

aluminum glycinate, glycerin, sodium polyacrylate. tartaric acid, DMOM hydantoin, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN4
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD4
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81484-301-022024-07-30C16284748780-11e7a6dab-1d59-a2ce-e063-dadaa90aadf7Lidocaine Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81484-301-01Lidocaine Patch1 in 1 BAGPATCH14
81484-301-02Lidocaine Patch6 in 1 BOXPATCH64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81484-301LIDOCAINE PATCH (LIDOCAINE 4% MENTHOL 1%) PATCH [ANHUI MIAO DE TANG PHARMACEUTICAL CO., LTD.]4Legacy NDC, 2 package rows20231115_cfba14e4-a834-a071-e053-2a95a90a658f.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
81484-30181484-301-01, 81484-301-02

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
0a284cca-a827-7498-e063-6394a90a9aa7cfba14e4-a834-a071-e053-2a95a90a658f2023-11-14WarningsExact identifier
spl id: 0a284cca-a827-7498-e063-6394a90a9aa7
spl set id: cfba14e4-a834-a071-e053-2a95a90a658f

Reported adverse events (FAERS/openFDA)#

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