Label: FIORE RX CRANAPPLE CRUSH ANTIFUNGAL NAIL POLISH- undecylenic acid film 

  • Label RSS
  • NDC Code(s): 52261-0206-0
  • Packager: Cosco International, Inc.
  • 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 09/13

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

  • ACTIVE INGREDIENT

    Active Ingredient                               Purpose
    Undecylenic Acid  3%........................Anti-fungal

    Anti-fungal
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  • WARNINGS

    Warnings  For external use only. Close
  • KEEP OUT OF REACH OF CHILDREN

    Do not use on children under 2 years of age unless directed by a doctor.
    KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice.

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if irritation occurs.

    Directions

    Clean nails and dry thoroughly.
    Remove any nail polish with nail
    polish remover. Allow to dry
    thoroughly. Roll your bottle of Fioré
    Rx Antifungal Nail Lacquer in between
    your hands to mix the lacquer
    thoroughly. Do not shake the bottle,
    as this can introduce air bubbles that
    will affect the quality of the lacquer.
    Using only the brush provided in the
    Fioré Rx bottle, apply a strip of
    lacquer down the middle of your nail
    from cuticle to tip before following it
    with lacquer on either side. Allow
    lacquer to dry for at least 2 minutes.
    For best results, apply a second coat
    and allow to dry for 30 minutes.

    Inactive ingredients:

    Butyl acetate, ethyl acetate, nitrocellulose, adipic acid/neopentyl glycol/trimellitic anhydride copolymer, acetyl tributyl citrate, isopropyl alcohol, propolis wax

    May contain:

    Stearalkonium Bentonite, Acrylates Copolymer, CI 77891, Styrene Acrylates Copolymer, CI 15850, Silica, Benzophenone-1, Trimethylpantanediyl Dibenzoate, Mica, Tin Oxide, CI 77510, CI 19140, CI 77491

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  • INGREDIENTS AND APPEARANCE
    FIORE RX CRANAPPLE CRUSH ANTIFUNGAL NAIL POLISH 
    undecylenic acid film
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52261-0206
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Undecylenic Acid (Undecylenic Acid) Undecylenic Acid 0.45 g  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    Butyl Acetate 6.314865 g  in 15 mL
    Ethyl Acetate 2.504385 g  in 15 mL
    Pyroxylin 1.96203 g  in 15 mL
    POLYESTER-10 1.40145 g  in 15 mL
    Acetyltributyl Citrate 0.981015 g  in 15 mL
    Isopropyl Alcohol 0.84087 mL  in 15 mL
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER 0.140145 g  in 15 mL
    Bentoquatam 0.126135 g  in 15 mL
    D&C Red No. 7 0.07128 g  in 15 mL
    Butyl Alcohol 0.07008 mL  in 15 mL
    Silicon Dioxide 0.042045 g  in 15 mL
    D&C Red No. 6 0.0312 g  in 15 mL
    Benzoresorcinol 0.028035 g  in 15 mL
    PROPOLIS WAX 0.015 g  in 15 mL
    Trimethylpentanediyl Dibenzoate 0.01401 g  in 15 mL
    D&C Red No. 34 0.007455 g  in 15 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52261-0206-0 15 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 05/22/2013
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    Name Address ID/FEI Business Operations
    Cosco International, Inc. 016433141 manufacture(52261-0206), label(52261-0206), pack(52261-0206)
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