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BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO (tolnaftate) solution
[Fisk Industries]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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

Barielle Professional PRO Fungus Rx Inner Package 1

Inner Package 2

Barielle Professional PRO Fungus Rx Inner Package 2

Outer Package 1

Barielle Professional PRO Fungus Rx Outer Package 1

Outer Package 2

Barielle Professional PRO Fungus Rx Outer Package 2

Outer Package 3

Barielle Professional PRO Fungus Rx Outer Package 3

Outer Package 4

Barielle Professional PRO Fungus Rx Outer Package 4

INGREDIENTS & APPEARANCE

BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42593-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42593-001-301 in 1 PACKAGE
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2012
Labeler - Fisk Industries (067633180)
Establishment
NameAddressID/FEIBusiness Operations
Private Label Partners, Inc.046033481manufacture

Revised: 2/2012
 
Fisk Industries