FDA.reportPublic FDA data

Lidocaine Pain Relief Gel Patch

Manufacturer
Dynarex
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:35:34

Label at a glance#

ProductLidocaine Pain Relief Gel Patch
Active ingredientLIDOCAINE
Label structure9 sections

Dosage and administration

Adults and children 12 years of age and over: 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 Patch should not be applied longer than an 8 hour period Children under 12 years of age: C onsult a doctor

Storage and handling

Avoid storing product in direct sunlight Protect product from excessive moisture

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Puropose

OTC - PURPOSE SECTION

Topical Anesthetic

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For External Use Only

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 the eyes, mucous membranes or rashes
  • Do not bandage tightly
  • Single use only

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

if pregnant or 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • 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
  • Patch should not be applied longer than an 8 hour period

Children under 12 years of age: 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

.

.Alpha.-Tocopherol Acetate, Azone, Carboxymethylcellulose Sodium , unspecified, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Fumed Silica, Glycerol, Phenoxyethanol, Polyacrylic Acid (800000MW), Polyoxyl 40 Hydrogenated Castor Oil, Propylene Glycol, Sodium Polyacrylate (2500000 MW), Tartaric Acid, Titanium Dioxide, Urea, Vanillyl Butyl Ether, Water

Questions?

OTC - QUESTIONS SECTION

1-888-DYNAREX

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1454 BX MASTER (R241119-2).jpg1454 BX MASTER (R241119-2).jpgLidocaine Pain Relief Patch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN11
1737778lidocaine 0.04 MG/MG Medicated PatchSCD11
1737778lidocaine 4 % Medicated PatchSY11

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130616784145426GTIN-13: 0616784145426
EAN-13: 0616784145426
GTIN-12: 616784145426
UPC-A: 616784145426
GTIN storage (14 digits): 00616784145426		1454 BX MASTER (R241119-2).jpg

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
67777-009-39Lidocaine Pain Relief Gel Patch40 mg in 1 PATCHPATCH4011
67777-009-39Lidocaine Pain Relief Gel Patch5 in 1 BOXPATCH511
67777-009-40Lidocaine Pain Relief Gel Patch60 in 1 CASEPATCH6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-009-39EA - Each67777-00945d38c91-4367-45c5-9131-4a1e3af4ecfb12023-02-06
67777-009-40EA - Each67777-009ecb8f4a8-79f3-4bc9-b33f-5ccc6e8394eb12023-02-06

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-00967777-009-39, 67777-009-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
UREA8W8T17847WIACT
POLYACRYLIC ACID (800000 MW)D0I6NSZ87UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
LIDOCAINE98PI200987ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
LAUROCAPRAM1F3X9DRV9XIACT

Source Document#

Source XML · Source PDF

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 Relief Gel PatchLIDOCAINE PAIN RELIEFDynarex960e4240-cd09-2560-e053-2a95a90a7bcf2026-01-28WarningsExact identifier
ndc (package): 67777-009-39
ndc (package): 67777-009-40
ndc (product): 67777-009
ndc11 (package): 67777000940
ndc11 (package): 67777000939
spl id: 4976f92d-e5db-290c-e063-6294a90afb17
spl set id: 960e4240-cd09-2560-e053-2a95a90a7bcf

Reported adverse events (FAERS/openFDA)#

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