FDA.reportPublic FDA data

Lidocaine 4% Patch

Manufacturer
SOLA Pharmaceuticals
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:20:34

Label at a glance#

ProductLidocaine 4% 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 over: Clean and dry the affected area Open pouch and remove one patch Apply 1 patch at a time to affected area; not more than 3 to 4 times daily Reseal pouch containing unused patches after each use Remove patch from the skin after at most 8-hour application Children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
  • Reseal pouch containing unused patches after each use
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Other Information

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Other Ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Questions or comments? 866-747-7365

Lidocaine 4% Patch

NDC 70512-812-30

Qty: 30 patches

Manufactured for:

SOLA Pharmaceuticals

Baton Rouge, LA 70810

Made in China

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN6
1737778lidocaine 0.04 MG/MG Medicated PatchSCD6
1737778lidocaine 4 % Medicated PatchSY6

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-130370512812300GTIN-13: 0370512812300
EAN-13: 0370512812300
GTIN-12: 370512812300
UPC-A: 370512812300
GTIN storage (14 digits): 00370512812300		box -2023.7.19.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
70512-812-30Lidocaine 4% Patch1 g in 1 POUCHPATCH16
70512-812-30Lidocaine 4% Patch30 in 1 BOXPATCH306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-812-30EA - Each70512-8129cca8263-4b7f-47d5-b482-97257960cb8e12023-12-05

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
70512-81270512-812-30

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
TITANIUM DIOXIDE15FIX9V2JPIACT
GLYCERINPDC6A3C0OXIACT
DISODIUM ETHYLENEDIAMINEDIACETATEEQL53S5L0FIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
KAOLIN24H4NWX5COIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE K90RDH86HJV5ZIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
TARTARIC ACIDW4888I119HIACT

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
Lidocaine 4% PatchLIDOCAINE 4%SOLA Pharmaceuticals078bc9a3-41b7-26a4-e063-6394a90a200d2025-12-08WarningsExact identifier
ndc (package): 70512-812-30
ndc (product): 70512-812
ndc11 (package): 70512081230
spl id: 45727ab5-5ee3-cd32-e063-6294a90ab656
spl set id: 078bc9a3-41b7-26a4-e063-6394a90a200d

Reported adverse events (FAERS/openFDA)#

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