FIORE RX ANTIFUNGAL NAIL LACQUER RED VELVET CAKE- undecylenic acid film 
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.

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Drug Facts

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

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.

Directions

Clean nails and dry thoroughly.
Remove any nail polish with nail
polish remover. Allow to dry
thoroughly. Roll your bottle of Fioré
Rx Antifungal Nail Lacquer in between
your hands to mix the lacquer
thoroughly. Do not shake the bottle,
as this can introduce air bubbles that
will affect the quality of the lacquer.
Using only the brush provided in the
Fioré Rx bottle, apply a strip of
lacquer down the middle of your nail
from cuticle to tip before following it
with lacquer on either side. Allow
lacquer to dry for at least 2 minutes.
For best results, apply a second coat
and allow to dry for 30 minutes.

Inactive ingredients:

Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax

May contain:

CI 60725, Benzophenone-3,

Bensophenone-1, Acrylates Copolymer,

Stearalkonium Bentonite, CI 15880, CI

15850, Silica, N-Butyl Alcohol, CI

15850:1, CI 77891,

Trimethylpentanediyl Dibenzoate,

Styrene Acrylates Copolymer,Mica, Tin

Oxide, CI 77510, CI 19140, CI 77491

Fiore Rx Drug Facts Label.jpg
FIORE RX ANTIFUNGAL NAIL LACQUER RED VELVET CAKE 
undecylenic acid film
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52261-0201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (Undecylenic Acid) Undecylenic Acid0.45 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Butyl Acetate6.314865 g  in 15 mL
Ethyl Acetate2.504385 g  in 15 mL
Pyroxylin1.96203 g  in 15 mL
POLYESTER-101.40145 g  in 15 mL
Acetyltributyl Citrate0.981015 g  in 15 mL
Isopropyl Alcohol0.84087 mL  in 15 mL
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER0.140145 g  in 15 mL
Bentoquatam0.126135 g  in 15 mL
D&C Red No. 70.07128 g  in 15 mL
Butyl Alcohol0.07008 mL  in 15 mL
Silicon Dioxide0.042045 g  in 15 mL
D&C Red No. 60.0312 g  in 15 mL
Benzoresorcinol0.028035 g  in 15 mL
PROPOLIS WAX0.015 g  in 15 mL
Trimethylpentanediyl Dibenzoate0.01401 g  in 15 mL
D&C Red No. 340.007455 g  in 15 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-0201-015 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/20/2013
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-0201), label(52261-0201), pack(52261-0201)

Revised: 9/2013
Document Id: f73e80ce-e1f9-4833-97f7-695adfb68860
Set id: 573091aa-78a0-41e0-a6f2-ac0076e9cc8f
Version: 7
Effective Time: 20130919
 
Cosco International, Inc.