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Nuvail

side effects drug center nuvail (poly-ureaurethane, 16% nail solution) drug

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    PROFESSIONAL

    CONSUMER

    Drug Description

    What is Nuvail and how is it used?

    Nuvail is a prescription medicine used to treat the symptoms of Nail Dystrophy (nail splitting or fragility) for intact or damaged nails. Nuvail may be used alone or with other medications.

    Nuvail belongs to a class of drugs called Dermatologics, Other.

    It is not known if Nuvail is safe and effective in children.

    What are the possible side effects of Nuvail?

    Nuvail may cause serious side effects including:

    • hives,
    • difficulty breathing,
    • swelling of your face, lips, tongue, or throat,
    • severe dizziness,
    • rash,
    • itching, and
    • skin irritation

    Get medical help right away, if you have any of the symptoms listed above.

    The most common side effects of Nuvail include:

    • stinging on application

    Tell the doctor if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of Nuvail. For more information, ask your doctor or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

     

    DESCRIPTION

    The product is a biocompatible, polymeric solution which forms a uniform film when applied to the nail. The product is dispersed in a non-cytotoxic solution which dries rapidly, adhering to the contours of the nail to form a flexible, waterproof barrier. The film will wear off naturally and must be reapplied as directed to be effective. The film is colorless, transparent and possesses good moisture vapor permeability.

    Ingredients

    16% Poly (urea-urethane) in organic solvents.

     

    Indications & Dosage

    INDICATIONS

    Nuvail™ is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. Nuvail coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.

     

    DOSAGE AND ADMINISTRATION

    Directions For Use

    • Application is recommended once a day before bedtime
    • Remove bottle cap, dip applicator into product and wipe off excess on lip of bottle
    • Apply in even strokes to affected nail plate [in entirety], proximal and lateral folds, and the distal tip
    • Allow the product to dry completely before applying pads or clothing
    • Replace cap with applicator on bottle when not in use
    • Clean affected nails with nail polish remover once a week

     

    HOW SUPPLIED

    Nuvail Nail Solution is supplied in a:

    15 ml non-sterile bottle with applicator 71403-044-01.

    Storage And Shelf Life

    For best results the product should be stored at room temperature (15° to 30°C, 59° to 86°F).

    Avoid storage in excessive heat and humidity. Refer to the bottle label for expiration date.

    Manufactured for: EPI Health, LLC, Charleston, SC 29403. Revised : Dec 2018

     

    Side Effects & Drug Interactions

    SIDE EFFECTS

    No Information provided

     

    DRUG INTERACTIONS

    No Information provided

     

    Warnings & Precautions

    WARNINGS

    Included as part of the PRECAUTIONS section.

    PRECAUTIONS

    The product is flammable in liquid form; avoid using near open flames and sources of ignition. Use in well-ventilated area. Keep out of reach of children.

    Store at room temperature away from heat. Do not allow product to come into contact with floors, counter tops, furniture or other finished surfaces - will stain.

    May temporarily sting upon application. Persons sensitized to isocyanate should not use this product. Should redness or other signs of irritation appear, discontinue use and consult your healthcare provider.

    Use of other products, ointments, creams or lotions before application of this product may prevent the film from forming correctly and reduce effectiveness.

     

    Overdosage & Contraindications

    OVERDOSE

    No Information provided

     

    CONTRAINDICATIONS

    Do not apply directly to deep, open, or profusely bleeding wounds.

     

    Clinical Pharmacology

    CLINICAL PHARMACOLOGY

    No Information provided

     

    Medication Guide

    PATIENT INFORMATION

    Please refer to the WARNINGS AND PRECAUTIONS sections.

    Directions For Use

    • Application is recommended once a day before bedtime
    • Remove bottle cap, dip applicator into product and wipe off excess on lip of bottle
    • Apply in even strokes to affected nail plate [in entirety], proximal and lateral folds, and the distal tip
    • Allow the product to dry completely before applying pads or clothing
    • Replace cap with applicator on bottle when not in use
    • Clean affected nails with nail polish remover once a week