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
Updated February 11, 2013
If you are a consumer or patient please visit this version.
- 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.Close
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.Close
16% Poly (urea-urethane) in organic solventsClose
Do not apply directly to deep, open, or profusely bleeding wounds.Close
- 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
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
- 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 weekClose
- How Supplied
Nuvail Nail Solution is suppled in a: 15 ML non-sterile bottle with applicator 68712-044-01Close
Manufactured for: Inncoutis Holdings LLC, Charleston SC 29401
For best results the product should be stored at room temperature (15º to 30ºC, 59º to 86ºF). Avoid storage in excessive heat and humidity.Close
Refer to the bottle label for expiration date.
- INGREDIENTS AND APPEARANCE
Product Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NHRIC:68712-044 Inactive Ingredients Ingredient Name Strength ACETONE (UNII: 1364PS73AF) METHYL ETHYL KETONE (UNII: 6PT9KLV9IO) ETHYLENE GLYCOL (UNII: FC72KVT52F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1,2-ETHANEDITHIOL (UNII: 92T634FLAR) 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)