LABOFLEX Lidocaine Pain Relieving Patch

Manufacturer
Laboflex, Inc. | WOOSHIN LAPACHE d.o.o.
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:15

Label at a glance#

ProductLABOFLEX Lidocaine Pain Relieving Patch
Active ingredientLIDOCAINE
Label structure13 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 physiciacn. 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%

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Lidocaine, Methyl paraben, Partially neutralized Sodium Polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl paraben, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water.

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 physiciacn.

  • 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

Keep Out of Reach of Children

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.

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Stop Use and Ask a Doctor if

OTC - STOP USE SECTION

Stop use and ask doctor if:

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

When Using This Product

OTC - WHEN USING SECTION

When using the product:

  • 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

Do not Use

OTC - DO NOT USE SECTION

Do not use:

  • On wounds or damaged skin
  • With a heantig pad
  • If you are allergic to any ingredients of this product

Warning

WARNINGS SECTION

For external use only

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Other information

SPL UNCLASSIFIED SECTION

Other Information:

  • 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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box with 5PatchesBox with 5Patches

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

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
83655-109-15LABOFLEX Lidocaine Pain Relieving Patch5 in 1 BOXPATCH51
83655-109-15LABOFLEX Lidocaine Pain Relieving Patch1 g in 1 POUCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83655-109LABOFLEX LIDOCAINE PAIN RELIEVING PATCH (LIDOCAINE 4%) PATCH [LABOFLEX, INC.]1Current NDC, 2 package rows20250402_31995f31-c272-afdb-e063-6294a90af3f9.zip

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
83655-10983655-109-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
ndc (package): 83655-109-15
ndc (product): 83655-109
ndc11 (package): 83655010915
spl id: 31995f54-889e-c027-e063-6294a90a3da3
spl set id: 31995f31-c272-afdb-e063-6294a90af3f9

Reported adverse events (FAERS/openFDA)#

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