FDA.reportPublic FDA data

LidoPro Patch

Manufacturer
Terrain Pharmaceuticals
Effective date
2024-02-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:10:52

Label at a glance#

ProductLidoPro Patch
Active ingredientLIDOCAINE, MENTHOL
Label structure11 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

Ad ults 18 years and older: • clean and dry affected area • open pouch and remove one patch • remove protective film from patch • apply one patch to the affected area of pain and leave in place for 8 to 12 hours • if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours • only use one patch at a time • wash hands with soap and water after applying or removing patch •...

Storage and handling

• some individuals may not experience pain relief until several minutes or hours after applying the patch • avoid storing product in direct sunlight • protect product from excessive moisture • store at 67-77°F (19-25°C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on the face or rashes, on wounds or damaged skin

• in the eyes, mouth, or other mucous membranes

• on genitals

• with a heating pad

• right before or after heart surgery

• any patch from a pouch that has been opened for 7 or more days

• in large quantities, particularly over raw surfaces or blistered areas

• if tamper-evident seal is torn, broken, or missing

• more than 2 patches per day unless directed by a doctor

• children under 18 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• allergies to topical products

• high blood pressure, heart disease, or kidney disease.

When using this product

OTC - WHEN USING SECTION

• avoid contact with eyes. If eye contact occurs, rinse thoroughly with water

• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and consult a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years and older:

• clean and dry affected area

• open pouch and remove one patch

• remove protective film from patch

• apply one patch to the affected area of pain and leave in place for 8 to 12 hours

• if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours

• only use one patch at a time

• wash hands with soap and water after applying or removing patch

• reseal pouch containing unused patches after each use

Other information

STORAGE AND HANDLING SECTION

• some individuals may not experience pain relief until several minutes or hours after applying the patch

• avoid storing product in direct sunlight

• protect product from excessive moisture

• store at 67-77°F (19-25°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

dihydroxyaluminum aminoacetate, glycerol, methylparaben, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, water

Questions?

OTC - QUESTIONS SECTION

877-985-8377

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box 1123-3box 1123-3

box 1123-1box 1123-1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53225-1123LIDOPRO PATCH (LIDOCAINE AND MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]1Unmatched20240228_124d3290-3166-9239-e063-6294a90a05bf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53225-1123-1EA - Each53225-1123dcfabba9-b54d-4904-baaa-35a536c23a2712024-04-05
53225-1123-3EA - Each53225-112357e22f10-64c9-495d-87ef-25942c739b7412024-04-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53225-112353225-1123-1, 53225-1123-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
GLYCERINPDC6A3C0OXIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
TARTARIC ACIDW4888I119HIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB

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
462b9188-6329-9169-e063-6394a90ae4a0124d3290-3166-9239-e063-6294a90a05bf2025-12-17WarningsExact identifier
spl set id: 124d3290-3166-9239-e063-6294a90a05bf

Reported adverse events (FAERS/openFDA)#

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