FDA.reportPublic FDA data

Pain Relief Gel-Patch

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:19:12

Label at a glance#

ProductPain Relief Gel-Patch
Active ingredientLIDOCAINE
Label structure15 sections

Dosage and administration

Adult 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 Remove patch from teh skin after at most 8-hour application Children under 12 years of age. Consult a doctor

Storage and handling

Store at controlled room temperature 68º-77ºF (20º-25ºC) 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 Anesthetic

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For External Use Only

Stop use and ask a doctor

OTC - STOP USE SECTION

  • Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Condition worsens
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

If Pregnant or Breast-Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

When Using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly

Directions

DOSAGE & ADMINISTRATION SECTION

Adult 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
  • Remove patch from teh skin after at most 8-hour application
  • Children under 12 years of age. Consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 68º-77ºF (20º-25ºC)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4802

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4802 Globe Lidocaine Patch 101323 CDER4802 Globe Lidocaine Patch 101323 CDER

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860003665725GTIN-13: 0860003665725
EAN-13: 0860003665725
GTIN-12: 860003665725
UPC-A: 860003665725
GTIN storage (14 digits): 00860003665725		4802 Globe Lidocaine Patch 101323 CDER.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
69396-134-15Pain Relief Gel-Patch15 in 1 BOXPATCH153
69396-134-15Pain Relief Gel-Patch1 g in 1 PATCHPATCH13

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-13469396-134-15

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
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYSORBATE 806OZP39ZG8HIACT
TARTARIC ACIDW4888I119HIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LIDOCAINE98PI200987ACTIB
KAOLIN24H4NWX5COIACT
EDETATE SODIUMMP1J8420LUIACT
POVIDONE K90RDH86HJV5ZIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT

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
Pain Relief Gel-PatchLIDOCAINE 4%Trifecta Pharmaceuticals USA, LLC.12a27ce7-c547-7134-e063-6394a90a94bd2025-12-02WarningsExact identifier
ndc (package): 69396-134-15
ndc (product): 69396-134
ndc11 (package): 69396013415
spl id: 44fa0730-e8db-61d2-e063-6394a90ac928
spl set id: 12a27ce7-c547-7134-e063-6394a90a94bd

Reported adverse events (FAERS/openFDA)#

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