FUNGI NAIL TOE AND FOOT PEN (UNDECYLENIC ACID ) LIQUID [KRAMER LABORATORIES]

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FUNGI NAIL TOE AND FOOT PEN (UNDECYLENIC ACID ) LIQUID [KRAMER LABORATORIES]
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NDC 55505-167-20
Set ID ee23692f-7461-4cc7-8924-2f59cf71a4b9
Category HUMAN OTC DRUG LABEL
Packager Kramer Laboratories
Generic Name
Product Class
Product Number
Application Number PART333C
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  • ACTIVE INGREDIENT

    Undecylenic acid 25%

  • PURPOSE


    Antifungal

  • KEEP OUT OF REACH OF CHILDREN

     KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center
    immediately for advice.

  • INDICATIONS & USAGE

    Uses ■ proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
    ■ for effective relief of itching, bur ning and cracking.

  • DOSAGE & ADMINISTRATION

    Directions ■ Clean affected are a with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail®Brand Toe & Foot™ Anti-Fungal Solution over affected area
    twice daily (morning and night) or as directed by a doctor. ■ The brush applicator allows for easy application under nails and surrounding cuticle area.

  • INACTIVE INGREDIENT

    Isopropyl Palmitate

  • WARNINGS

    For external use only


  • PRINCIPAL DISPLAY PANEL

    carton image

  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT PEN 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-167
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N) Undecylenic acid 250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-167-201.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product12/05/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/05/2010
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(55505-167)
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