Menthol 5% Patch
FDA Label NDC 71391-123

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 5% (NDC 71391-123). 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, otc - purpose, uses, warnings, do not use, 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

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

Otc - Purpose

Menthol 5% - Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Sprains
  • Strains
  • Bruises

Warnings

For external use only

Do Not Use

  • On wounds or damaged skin
  • With a heating pad

Ask A Doctor Before Use If You Have

  • Redness over affected area

When Using This Product

  • Avoid contact with eyes and mucous membranes
  • Do not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • Excessive skin irritation occurs

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.

Directions

  • Adults and children 12 years of age and older apply to the affected area no more than 3 to 4 times daily
  • Open pouch & remove patch
  • Peel off protective film and apply sticky side to affected area
  • Children under 12 years of age consult a doctor

Inactive Ingredients

Adhesive plaster, aloe extract, dl-camphor, purified lanolin, spearmint, titanium dioxide, zinc oxide

Questions

Call 1-215-666-3200

Principal Display Panel - 1 Patch Pouch

Lasts upto 8 Hours!

MENTHOL 5%
PATCH

XL

Pain Relief
BACK
PATCH
5% Menthol

Relieves Back Pain & Stiffness

• Not Messy or Greasy
• Comfortable, Breathable & Stays on Securely

1 Extra Large
Medicated Patch
9 x 4 in (22 x 10 cm)

Principal Display Panel (1 Patch Pouch)

Principal Display Panel (1 Patch Pouch)

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