FDA.reportPublic FDA data

LenzaPro Flex Patch

Manufacturer
SOLA Pharmaceuticals
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:20:42

Label at a glance#

ProductLenzaPro Flex
Active ingredientMENTHOL, LIDOCAINE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients:

Lidocaine HCL 4%

Menthol 4%

OTC - PURPOSE SECTION

Purpose:

Topical Anesthetic

INDICATIONS & USAGE SECTION

Uses:

For the temporary relief of pain

WARNINGS SECTION

Warnings:

For external use

OTC - DO NOT USE SECTION

Do not use:

  • More than 1 patch on your body at a time or on cut, iritated or swollen skin.
  • On puncture wounds
  • For more than 1 week without consulting a doctor

OTC - WHEN USING SECTION

When using this product:

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Rare cases of serious burns have been reported with products of this type.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not allow contact with the eyes and mucous membranes.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not use at the same time as other topical analgesics.
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Condition worsens
  • Redness is present
  • Irritation developes
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

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 and pets.

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

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children over 12 years:

  • Clean and dry the affected area.
  • Open pouch and remove one patch.
  • Remove the protective film from the patch and apply patch to the affected area.
  • Reseal pouch containing unused patches after each use.
  • Use 1 patch for up to 12 hours.

Children 12 years or younger:

  • Ask a doctor

OTHER SAFETY INFORMATION

Other Information:

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

INACTIVE INGREDIENT SECTION

Other Ingredients:

Acrylic Adhesive

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Questions or comments? 866-747-7365

Manufactured For:

SOLA Pharmaceuticals LLC

Baton Rouge, LA 70810

NDC: 70512-013-15

QTY: 15 Articulated patches (5 per Resealable Pouch) x 3

Lenzapro FlexLenzapro Flex

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2572014lidocaine HCl 4 % / menthol 4 % Medicated PatchPSN7
2572014lidocaine hydrochloride 0.04 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD7
2572014lidocaine HCl 4 % / menthol 4 % Medicated PatchSY7

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-130070512013157GTIN-13: 0070512013157
EAN-13: 0070512013157
GTIN-12: 070512013157
UPC-A: 070512013157
GTIN storage (14 digits): 00070512013157		LenzaPro Patch2 copy.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-013-15LenzaPro Flex3 in 1 BOXPATCH37
70512-013-15LenzaPro Flex1 g in 1 POUCHPATCH17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-013-15EA - Each70512-0132a3dd89e-8aed-4d3a-b817-bba1f2a0e08312021-04-08

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70512-01370512-013-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLIC ACIDJ94PBK7X8SIACT
MENTHOLL7T10EIP3AACTIB
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
LenzaPro FlexLIDOCAINE/MENTHOLSOLA Pharmaceuticalsba498f1d-460b-f4e6-e053-2995a90a57552025-12-08WarningsExact identifier
ndc (package): 70512-013-15
ndc (product): 70512-013
ndc11 (package): 70512001315
spl id: 457278e8-31e5-637e-e063-6394a90a808d
spl set id: ba498f1d-460b-f4e6-e053-2995a90a5755

Reported adverse events (FAERS/openFDA)#

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