MENTHOL 5% HYDROGEL PATCH

Manufacturer
Novamed Laboratories Private Limited
Effective date
2025-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:34:55

Label at a glance#

ProductHYDROGEL
Active ingredientMENTHOL
Label structure14 sections

Dosage and administration

Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use Children under 12 years of age: consult a physician.

Storage and handling

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Label contents#

Full prescribing information#

Active Ingredient                                           Purpose

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.0%........................................Topical analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • Over raw surfaces or blistered areas
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • If pouch is damaged or opened.

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

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 or breastfeeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use
  • Children under 12 years of age: consult a physician.

Other Information

STORAGE AND HANDLING SECTION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol, aluminum glycinate, benzyl alcohol, carboxymethylcellulose sodium, edetate disodium, ethylhexylglycerin, glycerin, isopropyl myristate, kaolin, methacrylate copolymer, phenoxyethanol, polysorbate 80, povidone, sodium polyacrylate, sorbitan monooleate, sorbitol, tartaric acid, titanium dioxide, water

OTC - QUESTIONS SECTION

Questions or CommentsCall +91 1276 457643

SPL UNCLASSIFIED SECTION

Manufactured By:
Novamed Laboratories Pvt. Ltd.
Plot No. 03, Sector 16, HSIIDC Industrial Estate,
Bahadurgarh, Haryana – 124507 (India)

MADE IN INDIA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Menthol 5% Hydrogel Patch Topical Analgesic - NDC 85267-003-01 - Pouch Label

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Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85267-00385267-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
3ccbf873-04d5-a3ba-e063-6294a90aeb1ad127aaae-e2cc-4757-a815-e912fff3bbc32025-08-20WarningsExact identifier
spl id: 3ccbf873-04d5-a3ba-e063-6294a90aeb1a
spl set id: d127aaae-e2cc-4757-a815-e912fff3bbc3

Reported adverse events (FAERS/openFDA)#

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