HYDROGEL
MENTHOL 5% HYDROGEL PATCH
d127aaae-e2cc-4757-a815-e912fff3bbc3
HUMAN OTC DRUG LABEL
Aug 20, 2025
Novamed Laboratories Private Limited
DUNS: 766401623
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MENTHOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (20)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Menthol 5% Hydrogel Patch Topical Analgesic - NDC 85267-003-01 - Pouch Label
INDICATIONS & USAGE SECTION
Use
For temporary relief of pain.
SPL UNCLASSIFIED SECTION
Manufactured By:
Novamed Laboratories Pvt. Ltd.
Plot No. 03, Sector 16, HSIIDC Industrial Estate,
Bahadurgarh, Haryana – 124507 (India)
MADE IN INDIA
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose
Menthol 5.0%........................................Topical analgesic
OTC - PURPOSE SECTION
WARNINGS SECTION
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use
- 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.
OTC - WHEN USING SECTION
When using this product
- 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.
OTC - STOP USE SECTION
Stop use and consult a doctor if
- 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- 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 SECTION
Other Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
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 Comments****Call +91 1276 457643