MENTHOL- menthol, unspecified form patch

Menthol by

Drug Labeling and Warnings

Menthol 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 7.5%

PURPOSE

Topical analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

• arthritis
• simple backache
• strains
• sprains
• bruises

Warnings

For external use only

Ask a doctor before use if you have

• Sensitive skin

When using this product

• Use only as directed
• Avoid contact with eyes and mucous membranes
• Do not apply to wounds or damaged skin
• Do not bandage tightly or use a heating pad

Stop use and ask a doctor if

• Excessive irritation or redness is present
• Condition worsens
• Pain persists for more than 7 days
• Symptom clear up and occur again within a few days

Do not use

• With other creams, ointments, sprays, liniments, or other topical products containing menthol.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years: Gently fold patch in half and remove one side of backing. Apply exposed adhesive to the site of pain. Remove remaining film from the other side and finish applying to skin. Use on affected areas for up to 12 hours. Children 12 years of age or younger: Consult a doctor

Other Information

Store in a cool & dry place. Protect from excessive moisture. Do not refrigerate or freeze.

Inactive Ingredients

Glyceryl Hydrogenated Rosinate, Mineral Oil, Styrene/Isoprene Copolymer

Questions or Comments

Call +91 9212228401

SPL UNCLASSIFIED SECTION

Manufactured By:

UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box

NDC: 71391-128-05

MENTHOL 7.5% PATCH

COOLING PAIN RELIEF PATCH
WITH 7.5% NATURAL MENTHOL

Backaches, Sore Muscles & Joint Pain
Fast Acting Cooling Relief

5 PATCHES
5.51" X 3.94"
(14cm X 10cm)

INGREDIENTS AND APPEARANCE

MENTHOL 
menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71391-128
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	105 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCEROL ESTER OF HYDROGENATED ROSIN (UNII: XH62RP786N)
Mineral Oil (UNII: T5L8T28FGP)
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71391-128-01	1 in 1 POUCH; Type 0: Not a Combination Product	11/15/2022
2	NDC: 71391-128-05	5 in 1 BOX	11/15/2022
2	NDC: 71391-128-01	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	11/15/2022

Labeler - Unexo Life Sciences Private Limited (872260479)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences Private Limited		872260479	MANUFACTURE(71391-128)