FDA.reportPublic FDA data

Barielle Professional Maximum Strength Fungus Rx Antifungal Solution PRO

Manufacturer
Fisk Industries | Private Label Partners, Inc.
Effective date
2012-02-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:30:53

Label at a glance#

ProductBarielle Professional Maximum Strength Fungus Rx Antifungal PRO
Active ingredientTOLNAFTATE
Label structure23 sections

Indications and uses

- Cures and prevents most athlete's foot (tinea pedis). - Effectively relieves itching, burning, cracking and scaling accompanying the above condition.

Dosage and administration

- To prevent athlete's foot, wash the feet and dry thoroughly. - Apply a thin layer of the product to the feet once or twice daily ( morning and/or night ). - Supervise children in the use of this product. - Pay special attention to spaces between the toes - Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                   Purpose
Tolnaftate 1.0%.................................Antifungal

Uses

INDICATIONS & USAGE SECTION

- Cures and prevents most athlete's foot (tinea pedis). - Effectively relieves itching, burning, cracking and scaling accompanying the above condition.

Warnings

WARNINGS SECTION

For external use only

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

- In case of accidental ingestion contact a physician, emergency medical care facility or poison control center.

Stop use

OTC - STOP USE SECTION

- Stop use and ask a physician if rash or irritation occurs.

Do not use

OTC - DO NOT USE SECTION

On children under 2 unless directed by a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

- To prevent athlete's foot, wash the feet and dry thoroughly. - Apply a thin layer of the product to the feet once or twice daily ( morning and/or night ). - Supervise children in the use of this product. - Pay special attention to spaces between the toes - Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

Other information

OTHER SAFETY INFORMATION

- You may report a serious adverse event from use of this product to Fisk Industries, Inc. 50 Ramland Road, Orangeburg, NY 10962

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, PEG-8, Cetearyl Alcohol, Ceteth-20 Phosphate, Decetyl Phosphate, Propylene Glycol, Cocamidopropyl Betaine, Octoxynol-9, Aloe Barbadensis Leaf Extract, Glyceryl Stearate, Hydroxyethyl Cellulose, Stearyl Alcohol, Imidazolidinyl Urea, Cetyl Alcohol, Methylparaben, Propylparaben, Triethanolamine.

Purpose

OTC - PURPOSE SECTION

Antifungal

Description

DESCRIPTION SECTION

NDC66425-006-20  117710
BIORIUS sprl, 2 rue René Descartes B-7000 Mons, Belgium DISTRIBUTED BY FISK INDUSTRIES ORANGEBURG, NY 10962, USA  Made in U.S.A.  LOT #  0326BR  7 20817 30326 1  PART #  0326FC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BARIELLE PROFESSIONAL MAXIMUM STRENTH FUNGUS RX ANTIFUNGAL SOLUTION PRO 30 ml / Fl. Oz. (U.S.) e

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Directions

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC66425-006-20  117710  Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUNGUS RX  PUISSANCE MAXIMUM  SOLUTION ANTIFONGIQUE  TUE LES GERMES QUI CAUSENT LES INFECTIONS FONGIQUES  PRO  30 ml / Fl. Oz. (U.S.) e

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL SOLUTION KILLS GERMS THAT CAN CAUSE FUNGAL INFECTIONS  PRO 30 ml / Fl. Oz. (U.S.) e  BIORIUS sprl, 2 rue René Descartes B-7000 Mons, Belgium DISTRIBUTED BY FISK INDUSTRIES ORANGEBURG, NY 10962, USA  Made in U.S.A.  LOT #

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUNGUS RX MAXIMA POTENCIA SOLUCION ANTIFUNGICA MATA LOS GERMENES QUE PUEDEN CAUSAR INFECCIONES FUNGICAS  PRO  30 ml / Fl. Oz. (U.S.) e  PART #  0326FC

Inner Package 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Barielle Professional PRO Fungus Rx Inner Package 1Barielle Professional PRO Fungus Rx Inner Package 1

Inner Package 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Barielle Professional PRO Fungus Rx Inner Package 2Barielle Professional PRO Fungus Rx Inner Package 2

Outer Package 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Barielle Professional PRO Fungus Rx Outer Package 1Barielle Professional PRO Fungus Rx Outer Package 1

Outer Package 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Barielle Professional PRO Fungus Rx Outer Package 2Barielle Professional PRO Fungus Rx Outer Package 2

Outer Package 3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Barielle Professional PRO Fungus Rx Outer Package 3Barielle Professional PRO Fungus Rx Outer Package 3

Outer Package 4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Barielle Professional PRO Fungus Rx Outer Package 4Barielle Professional PRO Fungus Rx Outer Package 4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243478FungusRx 1 % Topical SolutionPSN2
313423tolnaftate 1 % Topical SolutionPSN2
1243478tolnaftate 10 MG/ML Topical Solution [FungusRx]SBD2
313423tolnaftate 10 MG/ML Topical SolutionSCD2
1243478FungusRx 1 % Topical SolutionSY2
1243478FungusRx 10 MG/ML Topical SolutionSY2
313423tolnaftate 1 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42593-001-302019-11-13C16284748780-197449f38-bb7f-f6ea-e053-dbdaa90aa703Barielle Professional Maximum Strength Fungus Rx Antifungal Solution PRO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42593-001-30Barielle Professional Maximum Strength Fungus Rx Antifungal PRO30 mL in 1 BOTTLESOLUTION302
42593-001-30Barielle Professional Maximum Strength Fungus Rx Antifungal PRO1 in 1 PACKAGESOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42593-001BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO (TOLNAFTATE) SOLUTION [FISK INDUSTRIES]2Legacy NDC, 2 package rows20120203_b87c64ec-961b-4f66-a111-4ee25e55ba80.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV2
TOLNAFTATEACTIVE MOIETY06KB629TKV2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
CETETH-20INACTIVE INGREDIENTI835H2IHHX2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
IMIDUREAINACTIVE INGREDIENTM629807ATL2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
OCTOXYNOL 9INACTIVE INGREDIENT7JPC6Y25QS2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42593-00142593-001-30

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
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
OCTOXYNOL 97JPC6Y25QSIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARYL ALCOHOL2KR89I4H1YIACT
IMIDUREAM629807ATLIACT
CETYL ALCOHOL936JST6JCNIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
TROLAMINE9O3K93S3TKIACT

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 6 · 358 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / NASAL14 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRA-ARTICULAR0.03 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YLOTION / TOPICAL1140 mgExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
9 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUPPOSITORY / VAGINAL8.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
IMIDUREAIMIDUREAM629807ATLSHAMPOO / TOPICAL60 mgExact identifier — unii candidate
3 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / VAGINAL140 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 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
fd722a6c-7461-4256-9d67-0e68e9f11d40b87c64ec-961b-4f66-a111-4ee25e55ba802012-02-02WarningsExact identifier
spl id: fd722a6c-7461-4256-9d67-0e68e9f11d40
spl set id: b87c64ec-961b-4f66-a111-4ee25e55ba80

Reported adverse events (FAERS/openFDA)#

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