Fiore Rx Antifungal Propen
FDA Label NDC 52261-2500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Fiore Rx Antifungal Propen (NDC 52261-2500). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, directions:, inactive ingredients:, outer package plpdp, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Indications & Usage

→ directions:

→ inactive Ingredients:

→ Outer package Plpdp

→ Inner Package Plpdp

Otc - Active Ingredient

Active Ingredient Purpose
Undecylenic Acid 3%........................Anti-fungal

Otc - Purpose

Anti-fungal

Warnings

Warnings For external use only.

Otc - Keep Out Of Reach Of Children

Do not use on children under 2 years of age unless directed by a doctor.
KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice.

Indications & Usage

When using this product avoid contact with eyes.

Stop use and ask a doctor if irritation occurs.

Directions:

Cut nail straight across and round slightly at the edges. Throughly clean and dry areas to be treated. If there are any ares of thickness, file the nail to enhance absorption. Use the tip of the ProPen™ to gently push back the cuticle. Apply topical to the nail, under the nail, and some of the skin around the nail edge. Apply twice daily, morning and night. Allow topical to dry and absorb before putting on socks and shoes. Allow topical to dry before applying nail polish.

For best results, use Fiore Rx Antifungal Nail Lacquer™ in conjuction with the Fiore Rx Antifungal ProPen™ to treat and prevent nail fungus.

Inactive Ingredients:

Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Persea Gratissima (Avacado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Propolis Wax, BHT, Tocopheral Acetate