Fiore Rx CranApple Crush 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 22:36:58

Label at a glance#

ProductFiore Rx CranApple Crush 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 anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax

May contain:

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52261-0206-0	2020-01-31	C162847	48780-1	9d75b9cf-d4a8-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52261-0206-0	Fiore Rx CranApple Crush 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
52261-0206	FIORE RX CRANAPPLE CRUSH ANTIFUNGAL NAIL POLISH (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]	2	Legacy NDC, 1 package rows	20130920_4196cb63-de0e-4c76-b913-3a0bb85203b3.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
Butyl Alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	2
D&C Red No. 34	INACTIVE INGREDIENT	BAN556989E	2
D&C Red No. 6	INACTIVE INGREDIENT	481744AI4O	2
D&C Red No. 7	INACTIVE INGREDIENT	ECW0LZ41X8	2
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	INACTIVE INGREDIENT	905HNO1SIH	2
Ethyl Acetate	INACTIVE INGREDIENT	76845O8NMZ	2
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	2
POLYESTER-10	INACTIVE INGREDIENT	212N9O2MMZ	2
PROPOLIS WAX	INACTIVE INGREDIENT	6Y8XYV2NOF	2
Pyroxylin	INACTIVE INGREDIENT	KYR8BR2X6O	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	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 · 18 matching rows.

Fiore Rx CranApple Crush Antifungal Nail Polish
Undecylenic Acid
Butyl Acetate
Ethyl Acetate
Pyroxylin
POLYESTER-10
Acetyltributyl Citrate
Isopropyl Alcohol
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER
Bentoquatam
D&C Red No. 7
Butyl Alcohol
Silicon Dioxide
D&C Red No. 6
Benzoresorcinol
PROPOLIS WAX
Trimethylpentanediyl Dibenzoate
D&C Red No. 34

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52261-0206	52261-0206-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	IACT
Bentoquatam	7F465U79Q1	IACT
D&C Red No. 7	ECW0LZ41X8	IACT
Butyl Alcohol	8PJ61P6TS3	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
D&C Red No. 6	481744AI4O	IACT
Benzoresorcinol	LJ54R4Z029	IACT
PROPOLIS WAX	6Y8XYV2NOF	IACT
Trimethylpentanediyl Dibenzoate	Y8PB83G67A	IACT
D&C Red No. 34	BAN556989E	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 2 · 104 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 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
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 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
D&C Red No. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
D&C Red No. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Butyl Alcohol	BUTYL ALCOHOL	8PJ61P6TS3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
D&C Red No. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
D&C Red No. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET / SUBLINGUAL	0.01 mg		Exact identifier — unii candidate 7 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
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 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 / ORAL		120 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Butyl Alcohol	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 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
Ethyl Acetate	ETHYL ACETATE	76845O8NMZ	SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Butyl Alcohol	BUTYL ALCOHOL	8PJ61P6TS3	SOLUTION / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Ethyl Acetate	ETHYL ACETATE	76845O8NMZ	SOLUTION / TOPICAL	31 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 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, COATED / ORAL		160 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
D&C Red No. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Ethyl Acetate	ETHYL ACETATE	76845O8NMZ	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 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	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 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	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
Ethyl Acetate	ETHYL ACETATE	76845O8NMZ	CAPSULE, EXTENDED RELEASE / ORAL	382.26 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii candidate 9 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
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / AURICULAR (OTIC)		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
D&C Red No. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Butyl Alcohol	BUTYL ALCOHOL	8PJ61P6TS3	TABLET / ORAL	0.01 mg		Exact identifier — unii candidate 10 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
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	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
1c2ca992-c050-4ea6-a849-e5746b3e7eae			4196cb63-de0e-4c76-b913-3a0bb85203b3	2013-09-19	Warnings	Exact identifier spl id: 1c2ca992-c050-4ea6-a849-e5746b3e7eae spl set id: 4196cb63-de0e-4c76-b913-3a0bb85203b3

Reported adverse events (FAERS/openFDA)#

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