MENTHOL 5% HYDROGEL- menthol, unspecified form patch

Menthol 5% Hydrogel by

Drug Labeling and Warnings

Menthol 5% Hydrogel by is a Otc medication manufactured, distributed, or labeled by Unexo Life Sciences, Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Use

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

For external use only

When using this product

• 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

• 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 of breastfeeding, ask a health professional before use

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

• 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

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

Inactive Ingredients

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

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*

INGREDIENTS AND APPEARANCE

MENTHOL 5% HYDROGEL 
menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71391-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	600 mg

Inactive Ingredients
Ingredient Name	Strength
Butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 MW) (UNII: JZ1374NL9E)
Alcohol (UNII: 3K9958V90M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
Edetate disodium (UNII: 7FLD91C86K)
Dihydroxyaluminum aminoacetate (UNII: DO250MG0W6)
Glycerin (UNII: PDC6A3C0OX)
Kaolin (UNII: 24H4NWX5CO)
Methylparaben (UNII: A2I8C7HI9T)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Polyvinyl alcohol, unspecified (UNII: 532B59J990)
Propylparaben (UNII: Z8IX2SC1OH)
Povidone, unspecified (UNII: FZ989GH94E)
Sodium polyacrylate (2500000 MW) (UNII: 05I15JNI2J)
Sorbitan monooleate (UNII: 06XEA2VD56)
Sorbitol (UNII: 506T60A25R)
Tartaric acid (UNII: W4888I119H)
Titanium dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71391-127-05	5 in 1 POUCH; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/01/2020

Labeler - Unexo Life Sciences, Private Limited (872260479)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences, Private Limited		872260479	MANUFACTURE(71391-127)