Lidocaine 4% Patch #30

Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:46

Label at a glance#

ProductLIDOCAINE 4%
Active ingredientLIDOCAINE
Label structure14 sections

Indications and uses

For temporary relief of pain ​

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

PURPOSE & USE

OTC - PURPOSE SECTION

External Anesthetic- For temporary relief of pain

WARNINGS

WARNINGS SECTION

For external use only.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 Years of Age or Over:

  • Apply one 4% lidocaine patch at a time to the affected area.
  • Use up to 3 times daily, with each application lasting no more than 8 hours.
  • Clean and dry the skin before applying the patch.
  • Remove the patch after the specified duration and reseal the pouch containing unused patches.

Children Under 12 Years of Age: Consult a doctor for use.

Precautions:

  • Avoid applying to broken or irritated skin.
  • Do not apply more than one patch at a time.
  • Avoid using local heat sources on the area where the patch is applied.

DO NOT USE

OTC - DO NOT USE 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
  • 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:

  • allergies to topical products
  • high blood pressure, heart disease, or kidney disease

When using this product, 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 ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant of breast-feeding, ask a health professional before use

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, seek medical help or contact a Poison Control Center right away.

Dispose if the used patches by folding sticky ends together.

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of pain

​

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage

STOP USE ... IF

OTC - STOP USE SECTION

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days

CONSULT WITH A DOCTOR OR PHARMACIST BEFORE CONTINUED USE IF

OTC - ASK DOCTOR/PHARMACIST SECTION

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days

IF YOU ARE PREGNANT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ALWAYS FIRST CONSULT WITH A HEALTH PROFESSIONAL

KEEP OUT OF THE REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • 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

QUESTIONS?

OTC - QUESTIONS SECTION

Call toll-free: (307) 410-3813 or Email: info@marcellahealth.com

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine 4% PatchLidocaine 4% Patch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0542-1LIDOCAINE 4%30 in 1 BOXPATCH301
80425-0542-1LIDOCAINE 4%10 g in 1 PATCHPATCH101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0542-1EA - Each80425-0542756d27a7-18c9-4130-bec0-e508c5ce234912025-09-12
85096-201-30EA - Each85096-2010f9654ff-b570-4025-aca2-4d98f3b3202d12025-08-11

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80425-054280425-0542-1
85096-201

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE 4%LIDOCAINE 4%Advanced Rx of Tennessee, LLC3bdd6b3d-7180-288c-e063-6394a90a17852025-08-08WarningsExact identifier
ndc (package): 80425-0542-1
ndc (product): 80425-0542
ndc11 (package): 80425054201
spl id: 3bdd6b35-3725-fce6-e063-6294a90ad528
spl set id: 3bdd6b3d-7180-288c-e063-6394a90a1785
LIDOCAINE 4%LIDOCAINE 4%Marcella Health303d9462-cbfb-6251-e063-6394a90a70652025-03-13WarningsExact identifier
ndc (product): 85096-201

Reported adverse events (FAERS/openFDA)#

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