FDA.reportPublic FDA data

972 Medline 5% Menthol Pain Relief Patch

Manufacturer
Medline Industries, LP
Effective date
2025-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:05:45

Label at a glance#

ProductMedline
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains sprains bruises

Dosage and administration

Adult and children 2 years of age and older: clean and dry affected area remove film from patch and apply to the skin apply 1 patch at a time to affected area, not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 2 years of age: do not use, consult a doctor

Storage and handling

protect product from excessive moisture store in a cool dry place away from direct sunlight

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

Ask doctor before use if you have:

OTC - ASK DOCTOR 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
  • do not apply to wounds or damaged skin
  • do not use with other ointments, creams, sprays, or liniments
  • do not apply to irritated skin
  • avoid contact with eyes, mucous membranes or rashes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • burning discomfort or excessive skin irritation develops
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 years of age and older:

  • clean and dry affected area
  • remove film from patch and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 2 years of age: do not use, consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect product from excessive moisture
  • store in a cool dry place away from direct sunlight

Inactive 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, l-tartaric acid, mineral oil, petrolatum, polyacrylic acid, polysorbate 80, propylene glycol, pvp, sodium polyacrylate, titanium dioxide, water

Manufacturer information

SPL UNCLASSIFIED SECTION

©2025 CURAD and Medline are registered trademarks of Medline Industries, LP.
Manufactured for Medline Industries, LP,
Three Lakes Drive, Northfield, IL 60093 USA.
Made in China.
Ref. CUR997205 V1 RB25CFJ

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary box labelPrimary box labelinner pouchinner pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN2
420222menthol 0.05 MG/MG Medicated PatchSCD2
420222menthol 5 % Medicated PatchSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-972-05Medline5 in 1 BOXPATCH52
53329-972-05Medline1 in 1 POUCHPATCH12

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-97253329-972-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
POLYSORBATE 806OZP39ZG8HIACT
MENTHOLL7T10EIP3AACTIB
PETROLATUM4T6H12BN9UIACT
PVPFZ989GH94EIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
FRANKINCENSER9XLF1R1WMIACT
KAOLIN24H4NWX5COIACT
TARTARIC ACID, MESO-JQO211TF1AIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT

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
MedlineMENTHOLMedline Industries, LP0d947aa6-045e-d001-e063-6294a90a36572025-06-26WarningsExact identifier
ndc (package): 53329-972-05
ndc (product): 53329-972
ndc11 (package): 53329097205
spl id: 387c2d55-f00b-422f-e063-6294a90a898e
spl set id: 0d947aa6-045e-d001-e063-6294a90a3657

Reported adverse events (FAERS/openFDA)#

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