Fiore Rx Coral Sorbet Antifungal Nail Polish

Manufacturer: Cosco International, Inc.
Effective date: 2013-09-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:36:57

Label at a glance#

ProductFiore Rx Coral Sorbet Antifungal Nail Polish

Active ingredientUndecylenic Acid

Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Anti-fungal

WARNINGS SECTION

Warnings For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

INDICATIONS & USAGE SECTION

When using this product avoid contact with eyes.

Stop use and ask a doctor if irritation occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

May contain:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Back panel of bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1437982	Fiore Rx Antifungal 3 % Nail Polish	PSN	2
1437977	Undecylenic Acid 3 % Topical Solution	PSN	2
1437982	undecylenic acid 30 MG/ML Topical Solution [Fiore]	SBD	2
1437977	undecylenic acid 30 MG/ML Topical Solution	SCD	2
1437982	Fiore 30 MG/ML Topical Solution	SY	2
1437982	Fiore Rx 3 % Nail Polish	SY	2
1437977	Undecylenic Acid 3 % Topical Solution	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52261-0207-0	2020-01-31	C162847	48780-1	9d75b9d0-0034-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52261-0207-0	Fiore Rx Coral Sorbet Antifungal Nail Polish	15 mL in 1 BOTTLE, WITH APPLICATOR	FILM	15		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52261-0207	FIORE RX CORAL SORBET ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2	Legacy NDC, 1 package rows	20130919_516e190d-2d88-433e-ac47-8ad6e1bc0c99.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Undecylenic Acid	ACTIVE INGREDIENT	K3D86KJ24N	2
Undecylenic Acid	ACTIVE MOIETY	K3D86KJ24N	2
Acetyltributyl Citrate	INACTIVE INGREDIENT	0ZBX0N59RZ	2
BENTOQUATAM	INACTIVE INGREDIENT	7F465U79Q1	2
Benzoresorcinol	INACTIVE INGREDIENT	LJ54R4Z029	2
Butyl Acetate	INACTIVE INGREDIENT	464P5N1905	2
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	2
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	INACTIVE INGREDIENT	905HNO1SIH	2
Ethyl Acetate	INACTIVE INGREDIENT	76845O8NMZ	2
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	2
Polacrilin	INACTIVE INGREDIENT	RCZ785HI7S	2
POLYESTER-10	INACTIVE INGREDIENT	212N9O2MMZ	2
PROPOLIS WAX	INACTIVE INGREDIENT	6Y8XYV2NOF	2
Pyroxylin	INACTIVE INGREDIENT	KYR8BR2X6O	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
Trimethylpentanediyl Dibenzoate	INACTIVE INGREDIENT	Y8PB83G67A	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Fiore Rx Coral Sorbet Antifungal Nail Polish
Undecylenic Acid
Butyl Acetate
Ethyl Acetate
Pyroxylin
POLYESTER-10
Acetyltributyl Citrate
Isopropyl Alcohol
BENTOQUATAM
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER
TITANIUM DIOXIDE
Polacrilin
D&C RED NO. 6
Silicon Dioxide
Benzoresorcinol
PROPOLIS WAX
Trimethylpentanediyl Dibenzoate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52261-0207	52261-0207-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Undecylenic Acid	K3D86KJ24N	ACTIB
Butyl Acetate	464P5N1905	IACT
Ethyl Acetate	76845O8NMZ	IACT
Pyroxylin	KYR8BR2X6O	IACT
POLYESTER-10	212N9O2MMZ	IACT
Acetyltributyl Citrate	0ZBX0N59RZ	IACT
Isopropyl Alcohol	ND2M416302	IACT
BENTOQUATAM	7F465U79Q1	IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
Polacrilin	RCZ785HI7S	IACT
D&C RED NO. 6	481744AI4O	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Benzoresorcinol	LJ54R4Z029	IACT
PROPOLIS WAX	6Y8XYV2NOF	IACT
Trimethylpentanediyl Dibenzoate	Y8PB83G67A	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 130 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	PELLET / ORAL		55 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / AURICULAR (OTIC)		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Acetyltributyl Citrate	ACETYLTRIBUTYL CITRATE	0ZBX0N59RZ	TABLET / ORAL		150 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Ethyl Acetate	ETHYL ACETATE	76845O8NMZ	SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Acetyltributyl Citrate	ACETYLTRIBUTYL CITRATE	0ZBX0N59RZ	CAPSULE, COATED / ORAL		11 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Acetyltributyl Citrate	ACETYLTRIBUTYL CITRATE	0ZBX0N59RZ	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	TABLET / ORAL		120 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Acetyltributyl Citrate	ACETYLTRIBUTYL CITRATE	0ZBX0N59RZ	TABLET, EXTENDED RELEASE / ORAL		309 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Polacrilin	POLACRILIN	RCZ785HI7S	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	GRANULE / ORAL		229 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	TABLET, ORALLY DISINTEGRATING / ORAL		222 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Ethyl Acetate	ETHYL ACETATE	76845O8NMZ	FILM, EXTENDED RELEASE / TRANSDERMAL	0.05 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Acetyltributyl Citrate	ACETYLTRIBUTYL CITRATE	0ZBX0N59RZ	SOLUTION / TOPICAL	5.4 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	SUSPENSION / ORAL		255 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3c3e09f1-2aa8-4bf7-b4dc-8af16d0e3759			516e190d-2d88-433e-ac47-8ad6e1bc0c99	2013-09-19	Warnings	Exact identifier spl id: 3c3e09f1-2aa8-4bf7-b4dc-8af16d0e3759 spl set id: 516e190d-2d88-433e-ac47-8ad6e1bc0c99

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.