FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH- 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 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

Back panel of bottle

FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH 
undecylenic acid film
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52261-0207
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid 0.45 g  in 15 mL
Inactive Ingredients
Ingredient Name Strength
Butyl Acetate (UNII: 464P5N1905) 5.483175 g  in 15 mL
Ethyl Acetate (UNII: 76845O8NMZ) 3.353295 g  in 15 mL
Pyroxylin (UNII: KYR8BR2X6O) 2.081865 g  in 15 mL
POLYESTER-10 (UNII: 212N9O2MMZ) 1.059525 g  in 15 mL
Acetyltributyl Citrate (UNII: 0ZBX0N59RZ) 1.040925 g  in 15 mL
Isopropyl Alcohol (UNII: ND2M416302) 0.89223 mL  in 15 mL
BENTOQUATAM (UNII: 7F465U79Q1) 0.17844 g  in 15 mL
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) 0.167295 g  in 15 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.0939 g  in 15 mL
Polacrilin (UNII: RCZ785HI7S) 0.074355 g  in 15 mL
D&C RED NO. 6 (UNII: 481744AI4O) 0.03564 g  in 15 mL
Silicon Dioxide (UNII: ETJ7Z6XBU4) 0.029745 g  in 15 mL
Benzoresorcinol (UNII: LJ54R4Z029) 0.029745 g  in 15 mL
PROPOLIS WAX (UNII: 6Y8XYV2NOF) 0.015 g  in 15 mL
Trimethylpentanediyl Dibenzoate (UNII: Y8PB83G67A) 0.014865 g  in 15 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52261-0207-0 15 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 05/22/2013
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
Name Address ID/FEI Business Operations
Cosco International, Inc. 016433141 manufacture(52261-0207) , label(52261-0207) , pack(52261-0207)

Revised: 9/2013
Document Id: 3c3e09f1-2aa8-4bf7-b4dc-8af16d0e3759
Set id: 516e190d-2d88-433e-ac47-8ad6e1bc0c99
Version: 2
Effective Time: 20130919
 
Cosco International, Inc.