FDA.reportPublic FDA data

Lidocaine 4% Topical Patch

Manufacturer
SOLA Pharmaceuticals
Effective date
2026-05-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:56:05

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 or 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 4%

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 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 or 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

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​Questions or comments? 866-747-7365

Lidocaine 4% Patch

NDC 70512-014-30

Qty: 30 Flex Patches

(5 per resealable pouch) x 6

Manufactured for:

SOLA Pharmaceuticals

Baton Rouge, LA 70810

Carton LabelCarton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN9
1737778lidocaine 0.04 MG/MG Medicated PatchSCD9
1737778lidocaine 4 % Medicated PatchSY9

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-014-30Lidocaine 4% Patch5 g in 1 POUCHPATCH59
70512-014-30Lidocaine 4% Patch6 in 1 BOXPATCH69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-014-30EA - Each70512-01479ff6a9e-984f-42ba-a2cc-130713989a4a12021-06-02

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70512-01470512-014-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
FLAX SEED4110YT348CIACT
POLYSORBATE 806OZP39ZG8HIACT
ACRYLIC ACIDJ94PBK7X8SIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-08monthly-update2026-06-03 17:45:30

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 Pharmaceuticalsc31957dd-edea-ce98-e053-2a95a90a9c2d2026-05-05WarningsExact identifier
ndc (package): 70512-014-30
ndc (product): 70512-014
ndc11 (package): 70512001430
spl id: 511848da-e35b-2343-e063-6294a90ae321
spl set id: c31957dd-edea-ce98-e053-2a95a90a9c2d

Reported adverse events (FAERS/openFDA)#

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