FDA.reportPublic FDA data

973 Medline 4% Lidocain Pain Relief Patch

Manufacturer
Medline Industries, LP
Effective date
2025-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:05:45

Label at a glance#

ProductMedline
Active ingredientLIDOCAINE
Label structure9 sections

Dosage and administration

Adult and children 2 years of age and older: clean and dry affected area remove film from patch and apply to the skin apply 1 patch at a time to affected area, not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 2 years of age: do not use, consult a doctor

Storage and handling

avoid storing product in direct sunlight protect product from excessive moisture

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Ask doctor before use if you have:

OTC - ASK DOCTOR SECTION

sensitive skin

Do not use

OTC - DO NOT USE SECTION

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persists more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant of breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 years of age and older:

  • clean and dry affected area
  • remove film from patch and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application


Children under 2 years of age: do not use, consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

dihydroxyaluminum aminoacetate anhydrous, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, polyvinylpyrrolidone, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water

Manufacturer information

SPL UNCLASSIFIED SECTION

©2025 CURAD and Medline are registered trademarks of Medline Industries, LP.
Manufactured for Medline Industries, LP,
Three Lakes Drive, Northfield, IL 60093 USA.
Made in China.

REF CUR997305 V1 RB25CFJ

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary box labelPrimary box labelinner pouchinner pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

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
53329-973-05Medline5 in 1 BOXPATCH52
53329-973-05Medline1 in 1 POUCHPATCH12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-97353329-973-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 806OZP39ZG8HIACT
TARTARIC ACIDW4888I119HIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
KAOLIN24H4NWX5COIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
EDETATE DISODIUM7FLD91C86KIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
MedlineLIDOCAINEMedline Industries, LP0d6d0d4e-60d5-74b2-e063-6294a90a2da62025-06-26WarningsExact identifier
ndc (package): 53329-973-05
ndc (product): 53329-973
ndc11 (package): 53329097305
spl id: 387c2a5c-a28f-cbd3-e063-6394a90abe97
spl set id: 0d6d0d4e-60d5-74b2-e063-6294a90a2da6

Reported adverse events (FAERS/openFDA)#

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