FUNGUS MD (TOLNAFTATE) LIQUID [ORLY INTERNATIONAL INC]

FUNGUS MD (TOLNAFTATE) LIQUID [ORLY INTERNATIONAL INC]
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NDC 69061-101-11
Set ID 51e02f28-51f6-44d1-95d0-b910828b17ec
Generic Name
Product Class
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    TOLNAFTATE 1%

  • PURPOSE

    PURPOSE

    ANTIFUNGAL

  • INDICATIONS & USAGE

    Uses

    Effective treatment of athlete’s foot, jock itch and ringworm. Not for relief of infected finger nails and toe nails or effective against bacteria or viruses.

  • WARNINGS

    Warnings For external use only. Avoid contact with the eyes. Do not use on children under 2 years of age unless directed by a doctor. 

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • STOP USE

    If treating athlete’s foot and ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. If treating jock itch: If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Clean or wash the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athelete’s foot: Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

  • INACTIVE INGREDIENT

    Inactive Ingredients / Ingrédients Inactifs / Ingredientes Inactivos Aqua/Water/ Eau, PEG-8, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Propylene Glycol, Cocamidopropyl Betaine, Octoxynol-9, Glyceryl Stearate, Hydroxyethylcellulose, Stearyl Alcohol, Cetyl Alcohol, Methylparaben, Propylparaben, Imidazolidinyl Urea, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    FungusMD_.6oz_screen_GBL2690_scrn

    FungusMD_.6oz_UnitBox_CHP2690_cropped

  • INGREDIENTS AND APPEARANCE
    FUNGUS MD 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69061-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    IMIDUREA (UNII: M629807ATL)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69061-101-1118 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/18/2014
    Labeler - Orly International Inc (087181038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Private Label Partners, Inc.046033481manufacture(69061-101)

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