FDA.reportPublic FDA data

MediRelief Ultra Strength Menthol 5% Patch

Manufacturer
FARLA MEDICAL HEALTHCARE LTD
Effective date
2024-02-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:10:53

Label at a glance#

ProductMediRelief Ultra
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure7 sections

Indications and uses

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

Dosage and administration

adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each patch)

Purpose

Menthol 5%.................................................................................................................................................................

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

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • on a tight bandage
  • with a heating pad
  • on sensitive skin
  • if allergic to any ingredients in this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant of 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

  • adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature 68-77°F (20-25°C)
  • do not store in direct sunlight or expose to excessive heat and moisture

TAMPER EVIDENT: Do not use if pouch containing the patch is torn or broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose, dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, mineral oil, petrolatum, polyacrylic acid, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(Medium) Patch
NDC 73486-101-25

(Large) Patch
NDC 73486-101-35

Large PatchesLarge Patches

Medium PatchesMedium Patches

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73486-101-252024-02-26C16284748780-11030e365-14c7-111a-e063-dadaa90a10e2MediRelief Ultra Strength Menthol 5% Patch
73486-101-352024-02-26C16284748780-11030e365-14c7-111a-e063-dadaa90a10e2MediRelief Ultra Strength Menthol 5% Patch
73486-101-252024-01-30C16284748780-11030e365-14c7-111a-e063-dadaa90a10e2MediRelief Ultra Strength Menthol 5% Patch
73486-101-352024-01-30C16284748780-11030e365-14c7-111a-e063-dadaa90a10e2MediRelief Ultra Strength Menthol 5% Patch

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73486-101MEDIRELIEF ULTRA (MENTHOL) PATCH [FARLA MEDICAL HEALTHCARE LTD]6Legacy NDC20240228_a4dea2ad-59e3-306b-e053-2a95a90a56d8.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73486-10173486-101-25, 73486-101-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
POVIDONEFZ989GH94EIACT
METHYLPARABENA2I8C7HI9TIACT
KAOLIN24H4NWX5COIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TARTARIC ACIDW4888I119HIACT
PETROLATUM4T6H12BN9UIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
MINERAL OILT5L8T28FGPIACT

Source Document#

Source XML · Source PDF

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
46a1f276-c61c-3299-e063-6294a90ab962a4dea2ad-59e3-306b-e053-2a95a90a56d82025-12-23WarningsExact identifier
spl set id: a4dea2ad-59e3-306b-e053-2a95a90a56d8

Reported adverse events (FAERS/openFDA)#

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