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

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*

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton

MENTHOL 5% HYDROGEL
menthol, unspecified form patch

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Unexo Life Sciences, Private Limited (872260479)

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

MENTHOL 5% HYDROGEL PATCH