Label: BARIELLE FUNGUS RX MAXIMUM STRENGTH ANTI-FUNGAL- tolnaftate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 consumer or patient please visit this version.

  • 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

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

  • PRINCIPAL DISPLAY PANEL

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

  • PRINCIPAL DISPLAY PANEL

    Directions

  • Inner Package 1

    Inner Package 1

  • Inner Package 2

    Inner Package 2

  • INGREDIENTS AND APPEARANCE
    BARIELLE FUNGUS RX MAXIMUM STRENGTH ANTI-FUNGAL 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42593-002
    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:42593-002-301 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