FDA.reportPublic FDA data

Menthol Patch 5% Patch

Manufacturer
Unexo Life Sciences, Private Limited
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:52:37

Label at a glance#

ProductMenthol 5%
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Sprains Strains Bruises

Dosage and administration

Adults and children 12 years of age and older apply to the affected area no more than 3 to 4 times daily Open pouch & remove patch Peel off protective film and apply sticky side to affected area Children under 12 years of age consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Menthol 5% - Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • Simple backache
  • Arthritis
  • Sprains
  • Strains
  • Bruises

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • On wounds or damaged skin
  • With a heating pad

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Redness over affected area

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes and mucous membranes
  • Do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • Excessive skin irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older apply to the affected area no more than 3 to 4 times daily
  • Open pouch & remove patch
  • Peel off protective film and apply sticky side to affected area
  • Children under 12 years of age consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Adhesive plaster, aloe extract, dl-camphor, purified lanolin, spearmint, titanium dioxide, zinc oxide

Questions

OTC - QUESTIONS SECTION

Call 1-215-666-3200

SPL UNCLASSIFIED SECTION

Manufactured By:
UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)

PRINCIPAL DISPLAY PANEL - 1 Patch Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lasts upto 8 Hours!

MENTHOL 5%
PATCH

XL

Pain Relief
BACK
PATCH
5% Menthol

Relieves Back Pain & Stiffness

• Not Messy or Greasy
• Comfortable, Breathable & Stays on Securely

1 Extra Large
Medicated Patch
9 x 4 in (22 x 10 cm)

PRINCIPAL DISPLAY PANEL - 1 Patch Pouch
PRINCIPAL DISPLAY PANEL - 1 Patch Pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN3
420222menthol 0.05 MG/MG Medicated PatchSCD3
420222menthol 5 % Medicated PatchSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71391-123-18Menthol 5%1 in 1 POUCHPATCH13
71391-123-18Menthol 5%18 in 1 BOXPATCH183
71391-123-36Menthol 5%36 in 1 BOXPATCH363
71391-123-36Menthol 5%1 in 1 POUCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71391-123MENTHOL 5% (MENTHOL, UNSPECIFIED FORM) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]3Legacy NDC, 4 package rows20250115_f32bee71-fbba-46fb-9778-415f16b69912.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71391-12371391-123-18, 71391-123-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOEV5VD430YW9IACT
Camphor (synthetic)5TJD82A1ETIACT
Lanolin7EV65EAW6HIACT
SpearmintJ7I2T6IV1NIACT
Titanium Dioxide15FIX9V2JPIACT
Zinc OxideSOI2LOH54ZIACT

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
7c2191f3-6bd1-4c74-8f4e-b824015eb5aaf32bee71-fbba-46fb-9778-415f16b699122026-07-23WarningsExact identifier
spl set id: f32bee71-fbba-46fb-9778-415f16b69912

Reported adverse events (FAERS/openFDA)#

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