Label: NUVAIL- bandage, liquid

  • NDC Code(s): 68712-044-01
  • Packager: Innocutis Holdings LLC
  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 02/13

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

  • Intended Use

    Nuvailâ„¢ 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.

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  • Product Description

    The product is a biocompatible, polymeric solution which forms a uniform film when applied to the nail. The product is dispersed in a noncytotoxic 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 re-applied as directed to be effective. The film is colorless, transparent and possesses good moisture vapor permeability.

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  • Ingredients

    16% Poly (urea-urethane) in organic solvents

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  • Contraindications

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

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  • Warnings and 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.

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  • Directions for use


    Application is recommended once a daybefore 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 on bottle when not in use

    Clean affected nails with nail polish remover once a week

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  • How Supplied

    Nuvail Nail Solution is suppled in a: 15 ML non-sterile bottle with applicator 68712-044-01

    Manufactured for: Inncoutis Holdings LLC, Charleston SC 29401

    1-800-499-4468 www.Innocutis.com

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  • Storage

    For best results the product should be stored at room temperature (15º to 30ºC, 59º to 86ºF). Avoid storage in excessive heat and humidity.
    Refer to the bottle label for expiration date.

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  • Carton
  • INGREDIENTS AND APPEARANCE
    NUVAIL 
    bandage, liquid
    Product Information
    Product Type PRESCRIPTION MEDICAL DEVICE LABEL Item Code (Source) NHRIC:68712-044
    Inactive Ingredients
    Ingredient Name Strength
    ACETONE  
    METHYL ETHYL KETONE  
    ETHYLENE GLYCOL  
    PROPYLENE GLYCOL  
    1,2-ETHANEDITHIOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:68712-044-01 15 mL in 1 BOTTLE, GLASS; NCPDP billing unit = ML
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K120059 04/01/2004
    Labeler - Innocutis Holdings LLC (451549861)
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