FDA.reportPublic FDA data

Lidocaine Pain Relieving Patch

Manufacturer
BluePoint Laboratories | WOOSHIN LAPACHE d.o.o.
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:38:18

Label at a glance#

ProductLidocaine Pain Relieving Patch
Active ingredientLIDOCAINE
Label structure14 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 12 years of age : do not use, consult a physician. Clean and dry affected area Remove the film from the patch and apply to the affected area Use 1 patch at a time and not more than 3 to 4 times daily Remove patch from the skin after at most 8 hours application

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings:

WARNINGS SECTION

For external use only.

Do not Use

OTC - DO NOT USE SECTION

  • 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
  • Do not bandage tightly
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not apply to open wounds or damaged skin

Stop Use and Ask a Doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms persist for more than 7 days or clears up and occurs again within a few days
  • Severe burning sensation, redness or irritation develops
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children and Pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a physician.

  • Clean and dry affected area
  • Remove the film from the patch and apply to the affected area
  • Use 1 patch at a time and not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8 hours application

Other information

SPL UNCLASSIFIED SECTION

  • Do not use if the pouch is opened or damaged
  • Tighlty reseal the pouch containing unused patches
  • Store at room temperature
  • Do not freeze
  • This package is child-resistant

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Methyl parahydroxybenzoate (Methylparaben), Partially neutralized Sodium Polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate (Propylparaben), Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine Pain Relieving Patch Pouch 4%

NDC 68001-625-89

Rev 05/25

Lidocaine Pain Relieving Patch Patch Pouch Rev 0525Lidocaine Pain Relieving Patch Patch Pouch Rev 0525

Lidocaine Pain Relieving Patch 5 Patch Carton 4%

NDC 68001-625-93

Rev 08/25

Lidocaine Patch 5 Patch Carton Rev 0825Lidocaine Patch 5 Patch Carton Rev 0825

Lidocaine Pain Relieving Patch 30 Patch Carton 4%

NDC 68001-625-95

Rev 08/25

Lidocaine Patch 30 Patch Carton Rev 0825Lidocaine Patch 30 Patch Carton Rev 0825

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
68001-625-89Lidocaine Pain Relieving Patch1 g in 1 PATCHPATCH12
68001-625-93Lidocaine Pain Relieving Patch5 in 1 BOXPATCH52
68001-625-95Lidocaine Pain Relieving Patch30 in 1 BOXPATCH302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-625-89EA - Each68001-625f62e885b-20e5-40f2-b95f-edc919fc7f2212025-08-11
68001-625-93EA - Each68001-625e2e43ed4-2189-4332-8e36-d5299572f82212025-08-11
68001-625-95EA - Each68001-62527d82121-2ca5-4f1f-b680-f82a0a6a6ea012025-08-11

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
68001-62568001-625-89, 68001-625-93, 68001-625-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
TARTARIC ACIDW4888I119HIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE SODIUMMP1J8420LUIACT
PROPYLPARABENZ8IX2SC1OHIACT
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-06-25full-release2026-06-01 01:06:02

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
Lidocaine Pain Relieving PatchLIDOCAINE 4%BluePoint Laboratories3117273d-e006-2726-e063-6294a90a9c332025-10-08WarningsExact identifier
ndc (package): 68001-625-95
ndc (package): 68001-625-89
ndc (package): 68001-625-93
ndc (product): 68001-625
ndc11 (package): 68001062595
ndc11 (package): 68001062593
ndc11 (package): 68001062589
spl id: 40a91af2-8315-cb98-e063-6394a90a44e8
spl set id: 3117273d-e006-2726-e063-6294a90a9c33

Reported adverse events (FAERS/openFDA)#

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