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Fiore Rx Pink Peppermint Pie Antifungal Nail Polish

Medically reviewed on September 19, 2017

Dosage form: film
Ingredients: Undecylenic Acid 0.45g in 15mL
Labeler: Cosco International, Inc.
NDC Code: 52261-0200

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.

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:

Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491

FIORE RX PINK PEPPERMINT PIE ANTIFUNGAL NAIL POLISH 
undecylenic acid film
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0200
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 Acetate5.483175 g  in 15 mL
Ethyl Acetate3.353295 g  in 15 mL
Pyroxylin2.081865 g  in 15 mL
POLYESTER-101.059525 g  in 15 mL
Acetyltributyl Citrate1.040925 g  in 15 mL
Isopropyl Alcohol0.89223 mL  in 15 mL
BENTOQUATAM0.17844 g  in 15 mL
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER0.167295 g  in 15 mL
TITANIUM DIOXIDE0.0939 g  in 15 mL
Polacrilin0.074355 g  in 15 mL
D&C RED NO. 60.03564 g  in 15 mL
Silicon Dioxide0.029745 g  in 15 mL
Benzoresorcinol0.029745 g  in 15 mL
PROPOLIS WAX0.015 g  in 15 mL
Trimethylpentanediyl Dibenzoate0.014865 g  in 15 mL
Packaging
#Item CodePackage Description
1NDC:52261-0200-015 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/23/2013
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIOperations
Cosco International, Inc.016433141manufacture(52261-0200), label(52261-0200), pack(52261-0200)

 
Cosco International, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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