Label: BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO- tolnaftate solution

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 2, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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 AND APPEARANCE
    BARIELLE PROFESSIONAL MAXIMUM STRENGTH FUNGUS RX ANTIFUNGAL PRO 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42593-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!