MENTHOL 5% HYDROGEL PATCH

HYDROGEL by

Drug Labeling and Warnings

HYDROGEL by is a Otc medication manufactured, distributed, or labeled by Novamed Laboratories Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDROGEL- menthol patch 
Novamed Laboratories Private Limited

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MENTHOL 5% HYDROGEL PATCH

Drug Facts

Active Ingredient                                           Purpose

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

Use

For temporary relief of pain.

Warnings

For external use only

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.

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.

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.

If pregnant or breastfeeding,ask a health professional before use.

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

• 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

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

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

Questions or CommentsCall +91 1276 457643

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

MADE IN INDIA

PRINCIPAL DISPLAY PANEL

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

HYDROGEL 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85267-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85267-003-01	5 in 1 BOX	08/10/2025
1		1 in 1 POUCH
1		600 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/10/2025

Labeler - Novamed Laboratories Private Limited (766401623)

Establishment
Name	Address	ID/FEI	Business Operations
Novamed Laboratories Private Limited		766401623	manufacture(85267-003) , analysis(85267-003) , pack(85267-003) , label(85267-003)

Revised: 8/2025

Document Id: 3ccbf873-04d5-a3ba-e063-6294a90aeb1a

34390-5

Set id: d127aaae-e2cc-4757-a815-e912fff3bbc3

Version: 1

Effective Time: 20250820