FDA Label for Fiore Rx Antifungal Propen

View Indications, Usage & Precautions

Fiore Rx Antifungal Propen Product Label

The following document was submitted to the FDA by the labeler of this product Cosco International, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Outer Package Plpdp




Inner Package Plpdp




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