FDA.reportPublic FDA data

Menthol Patch Menthol 5% | Pain Relieving Patch

Manufacturer
Marcella Health
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:19

Label at a glance#

ProductMENTHOL 5%
Active ingredientMENTHOL, (+)-
Label structure13 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthrits backache strains sprains

Dosage and administration

Adults and Children 12 Years of Age or Over: Clean and dry the affected area, partially peel back the protective film and apply the exposed patch to the site of pain. Carefully remove the remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use. Children Under 12 Years of Age: Consult physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (IN EACH PATCH)

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

USES

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints

associated with:

  • arthrits
  • backache
  • strains
  • sprains

PURPOSE

OTC - PURPOSE SECTION

External Analgesic

WARNINGS

WARNINGS SECTION

For external use only.

CONSULT WITH A DOCTOR OR PHARMACIST BEFORE CONTINUED USE IF YOU HAVE

OTC - ASK DOCTOR/PHARMACIST SECTION

Sensitive Skin

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • Use only as directed
  • Do not bandage tightly or use with heating pad or device
  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments,creams,sprays, or liniments
  • Do not apply to irritated skin
  • Store in a cool, dry place away from sunlight

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

Burning discomfort or excessive skin irritation develops, condition wrosens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

IF YOU ARE PREGNANT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF YOU ARE PREGNANT OR BREAST-FEEDING: Consult with physician before use of this product.

KEEP OUT OF THE REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally ingested, get medical help or contact a Poison Control Center immediately

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 Years of Age or Over: Clean and dry the affected area, partially peel back the protective film and apply the exposed patch to the site of pain. Carefully remove the remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

Children Under 12 Years of Age: Consult physician.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Sodium Polyacrylate, Titanium dioxide, Water

QUESTIONS?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Menthol 5 Pouch.jpgMenthol 5 Pouch.jpg

Menthol 5 Box.jpgMenthol 5 Box.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN1
420222menthol 0.05 MG/MG Medicated PatchSCD1
420222menthol 5 % Medicated PatchSY1

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
85096-301-01MENTHOL 5%11 g in 1 PATCHPATCH111
85096-301-30MENTHOL 5%30 in 1 BOXPATCH301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85096-301MENTHOL 5% PATCH [MARCELLA HEALTH]1Current NDC, 2 package rows20250321_30914c0a-fbda-5674-e063-6294a90aba5b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85096-301-30EA - Each85096-301ecbae30c-0754-4262-b419-113c589dd63812025-08-11

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85096-30185096-301-01, 85096-301-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
POVIDONE K90RDH86HJV5ZIACT
PETROLATUM4T6H12BN9UIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
TARTARIC ACIDW4888I119HIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
CELLULOSE GUMK679OBS311IACT
FRANKINCENSER9XLF1R1WMIACT
MINERAL OILT5L8T28FGPIACT
MENTHOL, (+)-C6B1OE8P3WACTIB
ALOE VERA LEAFZY81Z83H0XIACT

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
MENTHOL 5%MENTHOL 5%Marcella Health30914c0a-fbda-5674-e063-6294a90aba5b2025-03-14WarningsExact identifier
ndc (package): 85096-301-30
ndc (package): 85096-301-01
ndc (product): 85096-301
ndc11 (package): 85096030101
ndc11 (package): 85096030130
spl id: 30916d71-bf2f-1bc0-e063-6394a90ab033
spl set id: 30914c0a-fbda-5674-e063-6294a90aba5b

Reported adverse events (FAERS/openFDA)#

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