LidoPro Patch

Manufacturer
Terrain Pharmaceuticals
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
25
Source
legacy-cache
Hydrated at
2026-08-01 21:18:12

Label at a glance#

ProductLidoPro Patch
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL, METHYL SALICYLATE
Label structure15 sections

Indications and uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: • muscle soreness • strains • sprains • arthritis • simple backache • muscle stiffness • bruises

Dosage and administration

Ad ults 18 years and older: • Apply patch to affected area 1 to 2 times daily or as directed.

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#

SPL UNCLASSIFIED SECTION

Methemoglobinemia

Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine-containing products and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

• muscle soreness

• strains

• sprains

• arthritis

• simple backache

• muscle stiffness

• bruises

Warnings

WARNINGS SECTION

For external use only

Stomach bleeding warning

WARNINGS SECTION

This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you

• are age 60 or older

• have had stomach ulcers or bleeding problems

• take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)

• take a blood thinning (anticoagulant) or steroid drug

• have three or more alcoholic drinks every day while using this product

• take more or for a longer time than directed

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

• if allergic to any NSAIDS

• right before or after heart surgery

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

• you are allergic to topical products

• the stomach bleeding warning applies to you

• you are taking a diuretic

• you have high blood pressure, heart disease, or kidney disease

• you are pregnant

When using this product

OTC - WHEN USING SECTION

• wash hands after applying or removing patch

• 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 your physician if

OTC - STOP USE SECTION

• stomach pain or upset gets worse or lasts

• rash, irritation, or itching develops

• you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)

• condition worsens

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use while breast feeding and during the first 6 months of pregnancy. 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, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years and older:

• Apply patch to affected area 1 to 2 times daily or as directed.

Instructions for Use

INSTRUCTIONS FOR USE SECTION

• clean and dry affected area

• open pouch and remove one patch containing medical adhesive backing

• remove protective film from both patch and medical adhesive

• 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

• do not use more than 2 patches per day

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

• reseal pouch containing unused patches after each use

Children under 18 years of age: Do not 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 INGREDIENT SECTION

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxynol-30, Polyacrylic Acid, Polysorbate 80, Sodium Polyacrylate, Sorbitan Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water

OTC - QUESTIONS SECTION

Manufactured For:

Terrain Pharmaceuticals

Reno, NV 89501

Formulated and Designed in Nevada

Assembled in China

Patent Pending

LidoProTM patch

For questions or comments, call

877-985-8377

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lidopropdplidopropdpfrontsmallfrontsmallbackback

NDC 53225-1023-1

Professional Use Only

LidoPro ™ patch

Transdermal Pain Relief Patch & Medical Adhesive

Deep Penetrating
Long Lasting
Soothing
15 Patches

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53225-1023-1EA - Each53225-10236dfc0115-b29a-434b-9b93-43e74a3ad4d712015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A2
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y2
LIDOCAINEACTIVE MOIETY98PI2009872
MENTHOLACTIVE MOIETYL7T10EIP3A2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
2-ETHYLHEXYL ACRYLATEINACTIVE INGREDIENTHR49R9S6XG2
ACRYLIC ACIDINACTIVE INGREDIENTJ94PBK7X8S2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN02
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3112
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91H2
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG1882
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6W2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341L2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5A2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
TALCINACTIVE INGREDIENT7SEV7J4R1U2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53225-102353225-1023-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 344 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TALCTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TOPICAL7 mgExact identifier — unii candidate
18 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HINJECTION, SOLUTION / INTRAVENOUS20 mgExact identifier — unii candidate
24 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TRANSDERMAL113 mgExact identifier — unii candidate
18 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HINJECTION / INTRAMUSCULAR11 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
78 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii candidate
40 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAVITREAL0.5 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / RECTAL72.15 mgExact identifier — unii candidate
78 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
TALCTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HCAPSULE / ORAL400 mgExact identifier — unii candidate
24 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / ORAL907 mgExact identifier — unii candidate
78 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / SOFT TISSUE15 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
44 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates

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
16eee6ab-9b3f-d7ce-e063-6394a90a0fee0943ccb6-c1ee-3a6f-e054-00144ff88e882024-04-25WarningsExact identifier
spl set id: 0943ccb6-c1ee-3a6f-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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