Label: FUNGI NAIL TOE AND FOOT PEN- undecylenic acid  liquid 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Undecylenic acid 25%

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  • PURPOSE


    Antifungal

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  • 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.

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  • 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.

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  • 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.

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  • INACTIVE INGREDIENT

    Isopropyl Palmitate

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  • WARNINGS

    For external use only


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  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT PEN 
    undecylenic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55505-167
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Undecylenic acid (Undecylenic acid ) Undecylenic acid 250 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL PALMITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55505-167-20 1.7 mL in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 12/05/2010
    Labeler - Kramer Laboratories (122720675)
    Establishment
    Name Address ID/FEI Business Operations
    Bioplan Innovative Sampling Inc 079158231 manufacture(55505-167)
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