FDA.reportPublic FDA data

Maximum Strength 4% Lidocaine Patch

Manufacturer
Solis Pharmaceuticals Inc.
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:00:02

Label at a glance#

ProductMaximum Strength 4% Lidocaine Patch
Active ingredientLIDOCAINE
Label structure14 sections

Indications and uses

for temporary relief of pain

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area remove backing layer from patch and apply to the affected area (see pictorial representation) remove patch from the skin after at most 8-hour application apply to affected area not more than 3 to 4 times daily children under 12 years of age : consult a doctor

Storage and handling

store at 20-25°C (68-77°F) protect product from direct sunlight and excessive moisture

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

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 one 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 rashes
  • avoid contact with the 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 or blistering
  • 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 and Pets

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

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove backing layer from patch and apply to the affected area (see pictorial representation)
  • remove patch from the skin after at most 8-hour application
  • apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • protect product from direct sunlight and 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 and Comments

OTC - QUESTIONS SECTION

Call 1-855-314-1850

Bulk Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


MAXIMUM STRENGTH
Pansolix® Pain Relieving Patch
4% Lidocaine
ODORFREE
NUMBS SENSITIVE NERVES FOR TEMPORARY RELIEF OF PAIN

  • BACK NECK
  • KNEES
  • ELBOWS
  • SHOULDERS

30 PATCHES 3-15/16" x 5-1/2" (10 cm x 14 cm)
BoxBox

FoilFoil

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

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
85185-001-30Maximum Strength 4% Lidocaine Patch1 in 1 POUCHPATCH13
85185-001-30Maximum Strength 4% Lidocaine Patch30 in 1 BOXPATCH303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85185-001MAXIMUM STRENGTH 4% LIDOCAINE PATCH (LIDOCAINE) PATCH [SOLIS PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250501_3061d301-2104-b1b2-e063-6394a90a9b6e.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
85185-00185185-001-30

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
POVIDONE K90RDH86HJV5ZIACT
POLYSORBATE 806OZP39ZG8HIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
KAOLIN24H4NWX5COIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

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
Maximum Strength 4% Lidocaine PatchLIDOCAINESolis Pharmaceuticals Inc.3061d301-2104-b1b2-e063-6394a90a9b6e2025-04-29WarningsExact identifier
ndc (package): 85185-001-30
ndc (product): 85185-001
ndc11 (package): 85185000130
spl id: 33ebe55d-5667-69b2-e063-6294a90a0646
spl set id: 3061d301-2104-b1b2-e063-6394a90a9b6e

Reported adverse events (FAERS/openFDA)#

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