FDA.reportPublic FDA data

Fiore Rx Rock Candy Clear Antifungal Nail Lacquer

Manufacturer
Cosco International, Inc.
Effective date
2013-09-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:36:57

Label at a glance#

ProductFiore Rx Rock Candy Clear Antifungal Nail Lacquer
Active ingredientUndecylenic Acid
Label structure7 sections

Dosage and administration

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 you...

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:

INACTIVE INGREDIENT 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

drug facts labeldrug facts label


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1437982Fiore Rx Antifungal 3 % Nail PolishPSN4
1437977Undecylenic Acid 3 % Topical SolutionPSN4
1437982undecylenic acid 30 MG/ML Topical Solution [Fiore]SBD4
1437977undecylenic acid 30 MG/ML Topical SolutionSCD4
1437982Fiore 30 MG/ML Topical SolutionSY4
1437982Fiore Rx 3 % Nail PolishSY4
1437977Undecylenic Acid 3 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-0203-02020-01-31C16284748780-19d75b9d1-077a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0203-0Fiore Rx Rock Candy Clear Antifungal Nail Lacquer15 mL in 1 BOTTLE, WITH APPLICATORFILM154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0203FIORE RX ROCK CANDY CLEAR ANTIFUNGAL NAIL LACQUER (UNDECYLENIC ACID) FILM [COSCO INTERNATIONAL, INC.]4Legacy NDC, 1 package rows20130919_7faf7a1c-6614-43bc-bef7-36b45d41f8a4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Undecylenic AcidACTIVE INGREDIENTK3D86KJ24N4
Undecylenic AcidACTIVE MOIETYK3D86KJ24N4
Acetyltributyl CitrateINACTIVE INGREDIENT0ZBX0N59RZ4
Butyl AcetateINACTIVE INGREDIENT464P5N19054
D&C Violet No. 2INACTIVE INGREDIENT350KA7O6HK4
Ethyl AcetateINACTIVE INGREDIENT76845O8NMZ4
Isopropyl AlcoholINACTIVE INGREDIENTND2M4163024
OxybenzoneINACTIVE INGREDIENT95OOS7VE0Y4
POLYESTER-10INACTIVE INGREDIENT212N9O2MMZ4
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF4
PyroxylinINACTIVE INGREDIENTKYR8BR2X6O4
Trimethylpentanediyl DibenzoateINACTIVE INGREDIENTY8PB83G67A4

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-020352261-0203-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Undecylenic AcidK3D86KJ24NACTIB
Butyl Acetate464P5N1905IACT
Ethyl Acetate76845O8NMZIACT
PyroxylinKYR8BR2X6OIACT
POLYESTER-10212N9O2MMZIACT
Acetyltributyl Citrate0ZBX0N59RZIACT
Isopropyl AlcoholND2M416302IACT
Oxybenzone95OOS7VE0YIACT
Trimethylpentanediyl DibenzoateY8PB83G67AIACT
PROPOLIS WAX6Y8XYV2NOFIACT
D&C Violet No. 2350KA7O6HKIACT

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 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
Acetyltributyl CitrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE, EXTENDED RELEASE / ORAL23 mgExact identifier — unii candidate
8 equally ranked IID candidates
Acetyltributyl CitrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE / ORAL7 mgExact identifier — unii candidate
8 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZSYSTEM / TRANSDERMAL41 mgExact identifier — unii candidate
7 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZSOLUTION / TOPICAL31 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZCAPSULE, EXTENDED RELEASE / ORAL382.26 mgExact identifier — unii candidate
7 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
Acetyltributyl CitrateACETYLTRIBUTYL CITRATE0ZBX0N59RZSOLUTION / TOPICAL5.4 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Acetyltributyl CitrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE, COATED / ORAL11 mgExact identifier — unii candidate
8 equally ranked IID candidates
Acetyltributyl CitrateACETYLTRIBUTYL CITRATE0ZBX0N59RZCAPSULE, DELAYED RELEASE / ORAL122 mgExact identifier — unii candidate
8 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZSOLUTION / ORAL13 mgExact identifier — unii candidate
7 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZSUSPENSION / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
Acetyltributyl CitrateACETYLTRIBUTYL CITRATE0ZBX0N59RZTABLET / ORAL150 mgExact identifier — unii candidate
8 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZFILM, EXTENDED RELEASE / TRANSDERMAL0.05 mgExact identifier — unii candidate
7 equally ranked IID candidates
Acetyltributyl CitrateACETYLTRIBUTYL CITRATE0ZBX0N59RZTABLET, EXTENDED RELEASE / ORAL309 mgExact identifier — unii candidate
8 equally ranked IID candidates
Acetyltributyl CitrateACETYLTRIBUTYL CITRATE0ZBX0N59RZTABLET, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
8 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6e3bcae5-e6bf-4455-ae30-8237138a2cc57faf7a1c-6614-43bc-bef7-36b45d41f8a42013-09-19WarningsExact identifier
spl id: 6e3bcae5-e6bf-4455-ae30-8237138a2cc5
spl set id: 7faf7a1c-6614-43bc-bef7-36b45d41f8a4

Reported adverse events (FAERS/openFDA)#

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