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Barielle Fungus Rx Maximum Strength Anti-Fungal (Fisk Industries)

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SOLUTION 1 BOTTLE in 1 PACKAGE (42593-002-30) > 30 mL in 1 BOTTLE Label Information

Complete Barielle Fungus Rx Maximum Strength Anti-Fungal Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:42593-002
    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:42593-002-30 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