Lidocaine Patch

Manufacturer
Hunan En Pu Pharmaceutical Co., Ltd.
Effective date
2024-04-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:29

Label at a glance#

ProductPain Relieving Patch
Active ingredientLIDOCAINE
Label structure13 sections

Storage and handling

store at room temperature 15°-30C (59-86F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LIDOCAINE 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

more than 1 patch on your body at a time
on cut,irritated,or swollen skin
on puncture wounds
for more than one week without consulting a doctor

OTC - WHEN USING SECTION

use only as directed. Read and follow all directions and warnings on this carton.
do not allow contact with the eyes
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 product away from children and pets.
Used patches stll contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

OTC - STOP USE SECTION

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness or irritation develops
you experience signs of skin injury, such as pain, sweling, or blistering where
the product was applied

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:
Wash and dry the affected area.
Peel off the backing film from one side of the patch carefully
Apply the exposed portion of the patch to the affected area.
Gently press the patch with your hand to fit the affected area completely.
Do not exercise vigorously during use to prevent the patch from falling off.
Use only 1 patch for a maximum of 8 hours.
Children under 12 years of age: Ask a doctor before use

STORAGE AND HANDLING SECTION

store at room temperature 15°-30C (59-86F).

INACTIVE INGREDIENT SECTION

aluminum glycinate
glycerin
methyl acrylate
polyacrylic acid
polysorbate 80
propylene glycol
sodium polyacrylate
tartaric acid
poval
alcohol

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84273-001-01Pain Relieving Patch1 in 1 BAGPATCH13
84273-001-01Pain Relieving Patch5 in 1 BOXPATCH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84273-001PAIN RELIEVING PATCH (LIDOCAINE 4%) PATCH [HUNAN EN PU PHARMACEUTICAL CO., LTD.]32 package rows20240427_16aa3bcc-81f7-6532-e063-6394a90ace29.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
84273-00184273-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
16fbd28d-c533-4a20-e063-6394a90a81c016aa3bcc-81f7-6532-e063-6394a90ace292024-04-26WarningsExact identifier
spl id: 16fbd28d-c533-4a20-e063-6394a90a81c0
spl set id: 16aa3bcc-81f7-6532-e063-6394a90ace29

Reported adverse events (FAERS/openFDA)#

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