Lidocaine Patch

Manufacturer
Anhui Miao De Tang Pharmaceutical Co., Ltd.
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:02:06

Label at a glance#

ProductLidocaine Patch
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure13 sections

Storage and handling

· Keep away from direc sunlight or heat · Store at room temperature (68-77F/20-25°C) · Protect product from excessive moisture · Patch comes in individual packaging

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LIDOCAINE PATCH

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4% Purpose:Topical Analgesic

OTC - PURPOSE SECTION

For the temporary relief of pain,LIDOCAINE PATCH

INDICATIONS & USAGE SECTION

LIDOCAINE PATCH to help Temporarily relteves minor pain

WARNINGS SECTION

For external use only. Flammable.

OTC - DO NOT USE SECTION

More than 1 patch at a time
On wounds or damaged skin
With a heating pad
If you have ever had an allergic reaction to this product or any of its ingredients

OTC - WHEN USING SECTION

Use only as directed
Avoid contact with the eyes, mucous membranes or rashes

Do not bandage tightly

OTC - STOP USE SECTION

Localized skin reaction occur, such as rash, itching, redness, iritation, pain, swelling and blistering

Condition worsens
Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

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.

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:
·Wash and dry the affected areaRemove 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 aected areaOnce exposed portion of

· patch is pooned.carefully remove remaining backing tocomplelely apply patch to afected areaCarefully 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

STORAGE AND HANDLING SECTION

· Keep away from direc sunlight or heat
· Store at room temperature (68-77F/20-25°C)
· Protect product from excessive moisture
· Patch comes in individual packaging

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, Menthol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box layoutBox layout

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012994lidocaine HCl 4 % Medicated PatchPSN5
1012994lidocaine hydrochloride 0.04 MG/MG Medicated PatchSCD5
1012994lidocaine HCl 4 % Medicated PatchSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81484-501-022024-07-30C16284748780-11e7a6dab-1e22-a2ce-e063-dadaa90aadf7​LIDOCAINE PATCH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81484-501-01Lidocaine Patch1 in 1 BAGPATCH15
81484-501-02Lidocaine Patch30 in 1 BOXPATCH305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81484-501LIDOCAINE PATCH (LIDOCAINE HCI 4%) PATCH [ANHUI MIAO DE TANG PHARMACEUTICAL CO., LTD.]52 package rows20231115_f6d7c4f0-89ab-0bcd-e053-6394a90af18f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81484-50181484-501-01, 81484-501-02

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
0a286ab2-a4ac-8792-e063-6294a90a7812f6d7c4f0-89ab-0bcd-e053-6394a90af18f2023-11-14WarningsExact identifier
spl id: 0a286ab2-a4ac-8792-e063-6294a90a7812
spl set id: f6d7c4f0-89ab-0bcd-e053-6394a90af18f

Reported adverse events (FAERS/openFDA)#

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