FIORE RX ANTIFUNGAL PROPEN- undecylenic acid liquid

Fiore Rx Antifungal ProPen by

Drug Labeling and Warnings

Fiore Rx Antifungal ProPen by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Anti-fungal

WARNINGS

Warnings  For external use only.

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

INGREDIENTS AND APPEARANCE

FIORE RX ANTIFUNGAL PROPEN 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-2500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N)	Undecylenic Acid	0.5 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
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
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)	0.01 g  in 2 g
PROPOLIS WAX (UNII: 6Y8XYV2NOF)	0.002 g  in 2 g
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	0.001 g  in 2 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.0002 g  in 2 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-2500-1	1 in 1 BOX
1	NDC: 52261-2500-0	2 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/21/2013

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-2500) , label(52261-2500) , pack(52261-2500)