Active Ingredient
Undecylenic Acid 25%
Antifungal Pen Liquid
FDA Label NDC 85210-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xf Agencija Limited for the product Antifungal Pen (NDC 85210-001). 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, uses, warnings, directions, other information, inactive ingredients, ndc 85210-001-01 (01 pen 3 ml), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
For the treatment of athlete's foot, jock itch, and ringworm.
Warnings
For external use only.
Directions
■ Read all warnings and directions
■ Use only as directed
■ Clean the affected area with soap and water and dry thoroughly
■ Remove cap from pen
■ Twist the base of the pen, with brush pointing downward, until product dispenses
■ 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 shoe, and change shoes and socks at least once daily.
Other Information
■ Store at 15°-30°C (59° - 86°F)
■ Keep cap on pen when not in use
Inactive Ingredients
Aloe Vera Extract, Sweet Almond Oil, Jojoba Oil, Tea Tree Oil, Manuka Oil, Clove Bud Oil, Lavender Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Tocopheryl Acetate (Vitamin E).
* Please review the disclaimer below.
