Menthol Patch
FDA Label NDC 71391-128

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unexo Life Sciences Private Limited for the product Menthol (NDC 71391-128). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, otc - purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (5 Patch Pouch Box)

Principal Display Panel (5 Patch Pouch Box)

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