FDA.reportPublic FDA data

Lidocaine and Menthol Pain Relieving Patch

Manufacturer
Marcella Health
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:42:26

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

frontfront

backback

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385096101306GTIN-13: 0385096101306
EAN-13: 0385096101306
GTIN-12: 385096101306
UPC-A: 385096101306
GTIN storage (14 digits): 00385096101306		Lidocaine Menthol Patch Carton Back 091025.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85096-101-30Lidocaine and Menthol30 in 1 CARTONPATCH302
85096-101-30Lidocaine and Menthol1 in 1 POUCHPATCH12

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
85096-10185096-101-30

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and MentholLIDOCAINE AND MENTHOLMarcella Healthd25f25ee-79f8-49e7-9715-0aae305b73e52025-11-03WarningsExact identifier
ndc (package): 85096-101-30
ndc (product): 85096-101
ndc11 (package): 85096010130
spl id: 42b74ab1-9fcb-d21f-e063-6294a90a21eb
spl set id: d25f25ee-79f8-49e7-9715-0aae305b73e5

Reported adverse events (FAERS/openFDA)#

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