BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO- tolnaftate solution

Barielle Professional Maximum Strength Fungus Rx Antifungal PRO by

Drug Labeling and Warnings

Barielle Professional Maximum Strength Fungus Rx Antifungal PRO by is a Otc medication manufactured, distributed, or labeled by Fisk Industries, Private Label Partners, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Uses

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

Warnings

For external use only

Keep out of reach of children

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

Stop use

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

Do not use

On children under 2 unless directed by a doctor.

Directions

- 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

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

Inactive ingredients

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

Antifungal

Description

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

Directions

PRINCIPAL DISPLAY PANEL

NDC66425-006-20  117710  Drug Facts

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

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 #

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

Inner Package 2

Outer Package 1

Outer Package 2

Outer Package 3

Outer Package 4

INGREDIENTS AND APPEARANCE

BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO 
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42593-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
IMIDUREA (UNII: M629807ATL)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42593-001-30	1 in 1 PACKAGE
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2012

Labeler - Fisk Industries (067633180)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Partners, Inc.		046033481	manufacture