FDA.reportPublic FDA data

Lidocaine and Menthol Pain Relieving Patch

Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2026-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-18 05:10:08

Label at a glance#

ProductLidocaine and Menthol
Active ingredientLIDOCAINE, MENTHOL
Label structure11 sections

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area, free of lotions, ointments, and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12-hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.

Label contents#

Full prescribing information#

Active ingredients (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

External Anesthetic

Active ingredients (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • more than one patch on your body at a time 
  • on cut, irritated or swollen skin 
  • on puncture wounds 
  • for more than one week without consulting a doctor 
  • if you are allergic to any active or inactive ingredients 
  • if pouch is damaged or opened

When using this

OTC - WHEN USING SECTION

  • use only as directed 
  • read and follow all directions and warnings on this carton 
  • do not allow contact with the eyes 
  • do not use at the same time as other topical analgesics 
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use 
  • do not microwave 
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • condition worsens 
  • redness is present 
  • irritation develops 
  • symptoms persist for more than 7 days or clear up and occur again within a few days 
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center 1-800-222-1222 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:clean and dry affected area, free of lotions, ointments, and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12-hour period. Maximum 2 patches per day. Discard patch after single use.
Children under 12 years of age:consult a physician.

Other information

SPL UNCLASSIFIED SECTION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polysorbate 80, povidone K90, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

Call (307) 410-3813 or email info@marcellahealth.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine and Menthol 4/1% Patch #30Lidocaine and Menthol 4/1% Patch #30

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128XXXXXXLidocaine and Menthol Patch 80425-0560-01.jpg
Data codeData Matrix0100380425056012210000006120761730063010XXXXXXLidocaine and Menthol Patch 80425-0560-01.jpg

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80425-056080425-0560-1
85096-101

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
KAOLIN24H4NWX5COIACT
MINERAL OILT5L8T28FGPIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE K90RDH86HJV5ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and MentholLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC44840250-2112-6ef4-e063-6394a90acdcc2026-06-12WarningsExact identifier
ndc (package): 80425-0560-1
ndc (product): 80425-0560
ndc11 (package): 80425056001
spl id: 44840256-4718-a719-e063-6394a90a5a14
spl set id: 44840250-2112-6ef4-e063-6394a90acdcc
Lidocaine and MentholLIDOCAINE AND MENTHOLMarcella Healthd25f25ee-79f8-49e7-9715-0aae305b73e52025-11-03WarningsExact identifier
ndc (product): 85096-101

Reported adverse events (FAERS/openFDA)#

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