FIORE RX ANTIFUNGAL PROPEN- undecylenic acid liquid 
Cosco International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Drug Facts

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


Warnings  For external use only.

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.

When using this product avoid contact with eyes.

Stop use and ask a doctor if irritation occurs.


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

drug facts label

Inner Package PLPDP

Product label

undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-2500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid0.5 g  in 2 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER SEED (UNII: R9N3379M4Z) 1.4368 g  in 2 g
SAFFLOWER OIL (UNII: 65UEH262IS) 0.03 g  in 2 g
AVOCADO OIL (UNII: 6VNO72PFC1) 0.02 g  in 2 g
PROPOLIS WAX (UNII: 6Y8XYV2NOF) 0.002 g  in 2 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.0002 g  in 2 g
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-2500-11 in 1 BOX
1NDC:52261-2500-02 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/21/2013
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-2500) , label(52261-2500) , pack(52261-2500)

Revised: 9/2013
Document Id: 08c5d7fd-ce4a-43da-9972-127cef00fe89
Set id: 5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed4
Version: 2
Effective Time: 20130919
Cosco International, Inc.