Active Ingredient
Undecylenic acid 25%
Trpwinner Toenail Fungus Pen Liquid
FDA Label NDC 85248-218
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Trpwinner Toenail Fungus Pen (NDC 85248-218). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
Treats most athlete's foot (tinea pedis) and ringworm (tinea corporis).
Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort.
Warnings
For external use only.
Do Not Use
on children under 2 years of age unless directed by a doctor.
When Using
avoid contact with eyes.
Stop Use
irritation occurs, or there is no improvement within 4 weeks.
Ask Doctor
irritation occurs, or there is no improvement within 4 weeks.
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
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over the affected area twice daily, morning and night, or as directed by a doctor.
For athlete’s foot, pay special attention to spaces between the toes. Wear well‑fitting, ventilated shoes and change shoes and socks at least once daily.
For athlete’s foot and ringworm, use daily for 4 weeks. If the condition persists longer, consult a doctor.
Other Information
Store at room temperature 15°C–30°C / 59°F–86°F.
Keep tightly closed when not in use.
Inactive Ingredients
Isopropyl Alcohol, Alcohol Denat, Menthol, Glycerin, Borneol.
Principal Display Panel
25 (405094d202ae46fde0554813a65f1923)
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