Prescribing Information

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Nuvail Full Prescribing Information

 

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 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 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 NDC 68712-044-01.

STORAGE AND SHELF LIFE
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.

Manufactured for:
Innocutis Holdings, LLC
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.innocutis.com

June 2012

US Patent No. 7,008,997; others pending

Nuvail NDC & Wholesaler Numbers

WholesalerNuvail 15 ml bottle
NDC 68712-044-01
Amerisource Bergen181-628/10106523
Cardinal4603437
H.D. Smith351-6309
McKesson Drug1713098
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