LIDOPRO PATCH

Manufacturer
DIRECT RX
Effective date
2023-10-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:24:53

Label at a glance#

ProductLIDOPRO
Active ingredientMETHYL SALICYLATE, MENTHOL, LIDOCAINE HYDROCHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 5%

Methyl Salicylate 4%

OTC - PURPOSE SECTION

Topical Analgesic

OTC - WHEN USING 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 SECTION

For external use only

Stomach bleeding warning

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

• 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

• 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

• 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

• 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,

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.

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.

OTC - PURPOSE SECTION

Adults 18 years and older:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

582582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

582-15582-15

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-582-152023-06-15C16284748780-1ba0f9c33-26ec-a910-e053-dadaa90a0b85LIDOPRO PATCH
61919-582-152021-01-29C16284748780-1ba0f9c33-26ec-a910-e053-dadaa90a0b85LIDOPRO PATCH

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-582-15EA - Each61919-582a7207f14-6544-4802-aa68-803583dd312a12019-05-02
53225-1023-1EA - Each53225-10236dfc0115-b29a-434b-9b93-43e74a3ad4d712015-01-05

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-58261919-582-15
53225-1023

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

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
0bc90313-11da-dd02-e063-6294a90a30876e9b6cc1-3b6c-4a92-e053-2a91aa0a54922023-12-05WarningsExact identifier
spl set id: 6e9b6cc1-3b6c-4a92-e053-2a91aa0a5492

Reported adverse events (FAERS/openFDA)#

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