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

Fiore Rx Antifungal Nail Lacquer Red Velvet Cake by

Drug Labeling and Warnings

Fiore Rx Antifungal Nail Lacquer Red Velvet Cake 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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIORE RX ANTIFUNGAL NAIL LACQUER RED VELVET CAKE 
undecylenic acid film

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-0201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N)	Undecylenic Acid	0.45 g  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
Butyl Acetate (UNII: 464P5N1905)	6.314865 g  in 15 mL
Ethyl Acetate (UNII: 76845O8NMZ)	2.504385 g  in 15 mL
Pyroxylin (UNII: KYR8BR2X6O)	1.96203 g  in 15 mL
POLYESTER-10 (UNII: 212N9O2MMZ)	1.40145 g  in 15 mL
Acetyltributyl Citrate (UNII: 0ZBX0N59RZ)	0.981015 g  in 15 mL
Isopropyl Alcohol (UNII: ND2M416302)	0.84087 mL  in 15 mL
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)	0.140145 g  in 15 mL
Bentoquatam (UNII: 7F465U79Q1)	0.126135 g  in 15 mL
D&C Red No. 7 (UNII: ECW0LZ41X8)	0.07128 g  in 15 mL
Butyl Alcohol (UNII: 8PJ61P6TS3)	0.07008 mL  in 15 mL
Silicon Dioxide (UNII: ETJ7Z6XBU4)	0.042045 g  in 15 mL
D&C Red No. 6 (UNII: 481744AI4O)	0.0312 g  in 15 mL
Benzoresorcinol (UNII: LJ54R4Z029)	0.028035 g  in 15 mL
PROPOLIS WAX (UNII: 6Y8XYV2NOF)	0.015 g  in 15 mL
Trimethylpentanediyl Dibenzoate (UNII: Y8PB83G67A)	0.01401 g  in 15 mL
D&C Red No. 34 (UNII: BAN556989E)	0.007455 g  in 15 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-0201-0	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	05/20/2013

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-0201) , label(52261-0201) , pack(52261-0201)