Active Ingredient
Undecylenic Acid 25%
Foot Choice-nail Fungal Pen Liquid
FDA Label NDC 87830-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foot Choice Llc for the product Foot Choice-nail Fungal Pen (NDC 87830-001). 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, do not use, when using this product, stop use and ask a doctor if, directions, 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 effective treatment of nail fungus, discoloration, thickening, splitting, crumbling, and brittleness.
Warnings
For external use only.
Do Not Use
- On children under 2 years of age unless directed by a doctor.
When Using This Product
- Avoid contact with the eyes.
Stop Use And Ask A Doctor If
- Irritation occurs or if there is no improvement within 4 weeks.
Directions
- Apply the product twice a day, in the morning and at night.
- For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove dirt, being cautious not to harm the nail bed. For best results, file nails every 2–3 days.
- Use the Nail Repair Pen Brush to apply the solution to the affected areas.
- Visible results will be seen in as little as 7 days. Continue regular usage to prevent fungus regrowth.
Inactive Ingredients
Aloe Vera Extract, Canola Oil, Clove Bud Oil, Lavender Oil, Jojoba Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond Oil, Tea Tree Oil, Tocopheryl Acetate (Vitamin E).
Ndc 87830-001-01
Foot_choice_pen_box_print (Foot Choice Pen Box Print)
* Please review the disclaimer below.
