FDA Label for Menthol

View Indications, Usage & Precautions

Menthol Product Label

The following document was submitted to the FDA by the labeler of this product Unexo Life Sciences Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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

Manufactured By:

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


Active Ingredient



Menthol 7.5%


Otc - 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.

Otc - Keep Out Of Reach Of Children



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


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


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)


* Please review the disclaimer below.