Fiore Rx Antifungal ProPen

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 22:37:00

Label at a glance#

ProductFiore Rx Antifungal ProPen

Active ingredientUndecylenic Acid

Label structure7 sections

Dosage and administration

Cut nail straight across and round slightly at the edges. Throughly clean and dry areas to be treated. If there are any ares of thickness, file the nail to enhance absorption. Use the tip of the ProPen™ to gently push back the cuticle. Apply topical to the nail, under the nail, and some of the skin around the nail edge. Apply twice daily, morning and night. Allow topical to dry and absorb before putting on s...

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

For best results, use Fiore Rx Antifungal Nail Lacquer™ in conjuction with the Fiore Rx Antifungal ProPen™ to treat and prevent nail fungus.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Persea Gratissima (Avacado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Propolis Wax, BHT, Tocopheral Acetate

Outer Package PLPDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

drug facts label

Inner Package PLPDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product label

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
52261-2500-1	2020-01-31	C162847	48780-1	9d75b9d1-07a7-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52261-2500-0	Fiore Rx Antifungal ProPen	2 g in 1 TUBE, WITH APPLICATOR	LIQUID	2		2
52261-2500-1	Fiore Rx Antifungal ProPen	1 in 1 BOX	LIQUID	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52261-2500	FIORE RX ANTIFUNGAL PROPEN (UNDECYLENIC ACID) LIQUID [COSCO INTERNATIONAL, INC.]	2	Legacy NDC, 2 package rows	20130924_5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed4.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
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
AVOCADO OIL	INACTIVE INGREDIENT	6VNO72PFC1	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	2
PROPOLIS WAX	INACTIVE INGREDIENT	6Y8XYV2NOF	2
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	2
SIMMONDSIA CHINENSIS SEED	INACTIVE INGREDIENT	D24K2Q1F6H	2
SUNFLOWER SEED	INACTIVE INGREDIENT	R9N3379M4Z	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Fiore Rx Antifungal ProPen
Undecylenic Acid
SUNFLOWER SEED
SAFFLOWER OIL
AVOCADO OIL
SIMMONDSIA CHINENSIS SEED
PROPOLIS WAX
BUTYLATED HYDROXYTOLUENE
.ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52261-2500	52261-2500-0, 52261-2500-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Undecylenic Acid	K3D86KJ24N	ACTIB
SUNFLOWER SEED	R9N3379M4Z	IACT
SAFFLOWER OIL	65UEH262IS	IACT
AVOCADO OIL	6VNO72PFC1	IACT
SIMMONDSIA CHINENSIS SEED	D24K2Q1F6H	IACT
PROPOLIS WAX	6Y8XYV2NOF	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	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 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, LIQUID FILLED / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii candidate
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 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
08c5d7fd-ce4a-43da-9972-127cef00fe89			5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed4	2013-09-19	Warnings	Exact identifier spl id: 08c5d7fd-ce4a-43da-9972-127cef00fe89 spl set id: 5dbf4be0-4a0a-47c5-8a4c-a190cd8e6ed4

Reported adverse events (FAERS/openFDA)#

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