Barielle Fungus Rx Maximum Strength Anti-Fungal Solution

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 Fungus Rx Maximum Strength Anti-Fungal

Active ingredientTOLNAFTATE

Label structure15 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

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

BIORIUS sprl, 2 rue René Descartes B-7000 Mons, Belgium DISTRIBUTED BY FISK INDUSTRIES ORANGEBURG, NY 10962, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BARIELLE FUNGUS RX MAXIMUM STRENTH ANTI-FUNGAL SOLUTION 30 ml / Fl. Oz. (U.S.) e

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Directions

Inner Package 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inner Package 1

Inner Package 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inner Package 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1243478	FungusRx 1 % Topical Solution	PSN	2
313423	tolnaftate 1 % Topical Solution	PSN	2
1243478	tolnaftate 10 MG/ML Topical Solution [FungusRx]	SBD	2
313423	tolnaftate 10 MG/ML Topical Solution	SCD	2
1243478	FungusRx 1 % Topical Solution	SY	2
1243478	FungusRx 10 MG/ML Topical Solution	SY	2
313423	tolnaftate 1 % Topical Solution	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42593-002-30	2019-11-13	C162847	48780-1	97449f38-bbe5-f6ea-e053-dbdaa90aa703	Barielle Fungus Rx Maximum Strength Anti-Fungal Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42593-002-30	Barielle Fungus Rx Maximum Strength Anti-Fungal	1 in 1 PACKAGE	SOLUTION	1		2
42593-002-30	Barielle Fungus Rx Maximum Strength Anti-Fungal	30 mL in 1 BOTTLE	SOLUTION	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42593-002	BARIELLE FUNGUS RX MAXIMUM STRENGTH ANTI-FUNGAL (TOLNAFTATE) SOLUTION [FISK INDUSTRIES]	2	Legacy NDC, 2 package rows	20120203_699abec8-6cc6-4ae7-bdd9-93b04ab7742f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	2
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	2
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	2
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
OCTOXYNOL 9	INACTIVE INGREDIENT	7JPC6Y25QS	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Barielle Fungus Rx Maximum Strength Anti-Fungal
TOLNAFTATE
WATER
POLYETHYLENE GLYCOL 400
CETOSTEARYL ALCOHOL
CETETH-20
PROPYLENE GLYCOL
COCAMIDOPROPYL BETAINE
OCTOXYNOL 9
ALOE VERA LEAF
GLYCERYL MONOSTEARATE
STEARYL ALCOHOL
IMIDUREA
CETYL ALCOHOL
METHYLPARABEN
PROPYLPARABEN
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42593-002	42593-002-30

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
Name	UNII	Kind
TOLNAFTATE	06KB629TKV	ACTIB
WATER	059QF0KO0R	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETETH-20	I835H2IHHX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
OCTOXYNOL 9	7JPC6Y25QS	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
IMIDUREA	M629807ATL	IACT
CETYL ALCOHOL	936JST6JCN	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
TROLAMINE	9O3K93S3TK	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 6 · 358 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CETETH-20	CETETH-20	I835H2IHHX	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOAP / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
OCTOXYNOL 9	OCTOXYNOL-9	7JPC6Y25QS	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / RECTAL	0.25 mg/mg		Exact identifier — unii candidate 36 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	AEROSOL, FOAM / TOPICAL		37 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAVENOUS		24186 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
OCTOXYNOL 9	OCTOXYNOL-9	7JPC6Y25QS	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 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
c0963865-9260-41f4-809b-1c16b0cda4bc			699abec8-6cc6-4ae7-bdd9-93b04ab7742f	2012-02-02	Warnings	Exact identifier spl id: c0963865-9260-41f4-809b-1c16b0cda4bc spl set id: 699abec8-6cc6-4ae7-bdd9-93b04ab7742f

Reported adverse events (FAERS/openFDA)#

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