MENTHOL 5% HYDROGEL 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 00:52:34

Label at a glance#

ProductMenthol 5% Hydrogel
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Dosage and administration

Adults and children 12 years of age and over: Carefully remove backing from patch. Applu sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age consult a physician.

Storage and handling

Store at room temperature below 86°F (30°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Rare cases of serious burns have been reported with products of this type
  • Don't bandage tightly or use with a heating pad
  • Avoid contact with eyes or mucous membranes
  • Don't apply to wounds or damaged skin
  • Do not use at the same time as other topical analgesics

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant of breastfeeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children. Do not use on infants. If swallowed, seek medical help or contact a Poison Control Centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: Carefully remove backing from patch. Applu sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age consult a physician.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature below 86°F (30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acrylates copolymer, alcohol, carboxymethylcellulose sodium, edetate Disodium, dihydroxyaluminium aminoacetate, glycerine, kaolin, methylparaben, polysorbate 80, polyvinyl alcohol, propylparaben, PVP, sodium polyacrylate, sorbitan oleate, sorbitol, tartaric Acid, titanium Dioxide, water

SPL UNCLASSIFIED SECTION

Manufactured in India By:
Unexo Life Sciences Pvt. Ltd.
B-16, Sector 4, Bawana Industrial Area,
Delhi - 110039 (INDIA)

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71391-127-05

UNEXO'S MENTHOL 5%
HYDROGEL PATCH

5% Menthol

BACK & LARGE AREAS

Targeted, Long-Lasting
Pain Relief

TOPICAL ANALGESIC

  • Adhesive Fabric Patch
  • No-Mess Application
  • Single Use

5
PATCHES
7.87 IN. X 3.93 IN. (20 cm × 10 cm)

Compare to Extra Strength
Icy Hot® Medicated Patch
active ingredient*

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton
PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton

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 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
71391-127-05Menthol 5% Hydrogel5 in 1 POUCHPATCH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71391-127MENTHOL 5% HYDROGEL (MENTHOL, UNSPECIFIED FORM) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]3Legacy NDC, 1 package rows20250115_3f6feec5-2019-4fe6-b2b9-fd1c04d9a1f1.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71391-12771391-127-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
4baddbc0-c919-477c-8b1a-0f005ec558103f6feec5-2019-4fe6-b2b9-fd1c04d9a1f12026-07-23WarningsExact identifier
spl set id: 3f6feec5-2019-4fe6-b2b9-fd1c04d9a1f1

Reported adverse events (FAERS/openFDA)#

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