NUVAIL () [INNOCUTIS HOLDINGS LLC]

NUVAIL () [INNOCUTIS HOLDINGS LLC]
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NDC 68712-044-01
Set ID c8bb98ea-cefe-4fae-adf8-3ab9e56f164c
Category PRESCRIPTION MEDICAL DEVICE LABEL
Packager Innocutis Holdings LLC
Generic Name
Product Class
Product Number
Application Number K120059
  • Intended Use

    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.

  • 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.

  • Ingredients

    16% Poly (urea-urethane) in organic solvents

  • Contraindications

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

  • 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.

  • 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

  • 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

  • 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.

  • Carton

    image description

  • INGREDIENTS AND APPEARANCE
    NUVAIL 
    bandage, liquid
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:68712-044
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    METHYL ETHYL KETONE (UNII: 6PT9KLV9IO)  
    ETHYLENE GLYCOL (UNII: FC72KVT52F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    1,2-ETHANEDITHIOL (UNII: 92T634FLAR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:68712-044-0115 mL in 1 BOTTLE, GLASS; NCPDP billing unit = ML
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK12005904/01/2004
    Labeler - Innocutis Holdings LLC (451549861)