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 PIXIE DUST PINK ANTIFUNGAL NAIL POLISH
undecylenic acid film

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52261-0204
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Butyl Acetate (UNII: 464P5N1905)	6.2260095 g in 15 mL
Ethyl Acetate (UNII: 76845O8NMZ)	2.527011 g in 15 mL
Pyroxylin (UNII: KYR8BR2X6O)	1.979754 g in 15 mL
POLYESTER-10 (UNII: 212N9O2MMZ)	1.41411015 g in 15 mL
Acetyltributyl Citrate (UNII: 0ZBX0N59RZ)	0.98987715 g in 15 mL
Isopropyl Alcohol (UNII: ND2M416302)	0.84846615 mL in 15 mL
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)	0.141411 g in 15 mL
Bentoquatam (UNII: 7F465U79Q1)	0.1272684 g in 15 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	0.0973554 g in 15 mL
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)	0.07071285 g in 15 mL
Silicon Dioxide (UNII: ETJ7Z6XBU4)	0.04242765 g in 15 mL
Benzoresorcinol (UNII: LJ54R4Z029)	0.02828505 g in 15 mL
MICA (UNII: V8A1AW0880)	0.0267153 g in 15 mL
PROPOLIS WAX (UNII: 6Y8XYV2NOF)	0.015 g in 15 mL
Trimethylpentanediyl Dibenzoate (UNII: Y8PB83G67A)	0.0141426 g in 15 mL
D&C RED NO. 34 (UNII: BAN556989E)	0.0007122 g in 15 mL
D&C RED NO. 6 (UNII: 481744AI4O)	0.00037785 g in 15 mL
STANNIC OXIDE (UNII: KM7N50LOS6)	0.00036345 g in 15 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52261-0204-0	15 mL in 1 BOTTLE, WITH APPLICATOR

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

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Name	Address	ID/FEI	Business Operations
Establishment
Cosco International, Inc.		016433141	manufacture(52261-0204) , label(52261-0204) , pack(52261-0204)