MENTHOL- menthol, unspecified form patch 
Unexo Life Sciences Private Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Menthol 7.5% Patch

Drug Facts

Active Ingredient

Menthol 7.5%

Topical analgesic

Uses

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

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

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)

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box
MENTHOL 
menthol, unspecified form patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM105 mg
Inactive Ingredients
Ingredient NameStrength
GLYCEROL ESTER OF HYDROGENATED ROSIN (UNII: XH62RP786N)  
Mineral Oil (UNII: T5L8T28FGP)  
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71391-128-011 in 1 POUCH; Type 0: Not a Combination Product11/15/2022
2NDC:71391-128-055 in 1 BOX11/15/2022
2NDC:71391-128-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34811/15/2022
Labeler - Unexo Life Sciences Private Limited (872260479)
Establishment
NameAddressID/FEIBusiness Operations
Unexo Life Sciences Private Limited872260479MANUFACTURE(71391-128)

Revised: 11/2022
Document Id: b8ee1003-ec8c-4c59-9e02-1cad729e1ef7
Set id: c991cc06-cb3a-4e6a-9595-f689c8fa63b6
Version: 1
Effective Time: 20221109
 
Unexo Life Sciences Private Limited