Foot Cure Nail Repair Pen Solution
FDA Label NDC 83691-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sansar, Llc for the product Foot Cure Nail Repair Pen (NDC 83691-011). 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

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

For the Effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and britteleness 

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 eyes.

Stop Use And Ask A Doctor If

  •  irritation occurs or there is no improvement within 4 weeks.

Directions

1. Apply the product twice a day, in the morning and at night.

2. 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 cautios not to harm the nail bed. For best results file nails every 2-3 days.

3. Use the Nail Repair pen brush to apply the solution on the affected areas.

4. 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)

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