Active Ingredient

Manufacturer
PHARMACURE LLC
Effective date
2026-10-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-15 01:01:46

Label at a glance#

ProductLIDOCAINE
Active ingredientLIDOCAINE
Label structure10 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

Adults and children 12 years and over : apply 1 to 2 patches to the affected area of intact skin. Lidocaine patch should be removed after 12 hours of continuous use and remain off for at least 12 hours.

Storage and handling

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. 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

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

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, 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, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or 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.

Stop use and consult your physician if rash, irritation, or itching develops, or condition worsens.

If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is put in mouth, get medical help of contact a Poison Control Center right away. Package is not child resistant. Dispose of the used patches by folding sticky ends together.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over: apply 1 to 2 patches to the affected area of intact skin. Lidocaine patch should be removed after 12 hours of continuous use and remain off for at least 12 hours.

SPL UNCLASSIFIED SECTION

INSTRUCTIONS FOR USE

  • Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors 
  • Safely discard the remaining unused pieces of cut patches where children and pets cannot reach 
  • Remove the transparent protective film (clear plastic barrier) before application of patches to the skin 
  • Apply immediately after removing the protective film Apply 1 patch to the affected area so that the patch covers all or most of the painful area
  • Remove patch if irritation occurs

Children under 12 years of age: Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, polyacrylic acid, propyl p-hydroxybenzoate, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

Other information

STORAGE AND HANDLING SECTION

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-005-01EA - Each79643-005eff8457e-3d25-4e81-89d1-2fead46e8c3512025-02-10

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79643-00579643-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-06full-release2026-06-01 01:38:29
22024-12-16full-release2026-06-01 00:44:35

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINELIDOCAINEPHARMACURE LLC31d5e5c9-6ec4-4496-8a4c-cca39a2cbe322025-10-06WarningsExact identifier
ndc (package): 79643-005-01
ndc (product): 79643-005
ndc11 (package): 79643000501
spl set id: 31d5e5c9-6ec4-4496-8a4c-cca39a2cbe32

Reported adverse events (FAERS/openFDA)#

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