Drug Product Name:

NUVAIL Rx

NUVAIL

Active Ingredient(s):
Poly-ureaurethane 16%; nail solution.

Company
Innocutis

Indication(s):

For managing signs/symptoms of nail dystrophy (eg, nail splitting, fragility) for intact or damaged nails.

Pharmacology:

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. 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.

Legal Classification:

Rx

Adults:

Apply to affected nail(s) once daily before bedtime. Allow product to dry completely before applying pads or clothing. Clean affected nails with nail polish remover once a week.

Children:

Not established.

Contraindication(s):

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

Warnings/Precautions:

Product is flammable. Do not allow product to come in contact with floors, countertops, furniture, or other finished surfaces; will stain. Persons sensitized to isocyanate: do not use. Discontinue if redness or irritation occurs.

Interaction(s)

Ointments, creams, lotions may prevent film from forming correctly and reduce effectiveness if put on before application.

Adverse Reaction(s)

Stinging upon application.

How Supplied:

Sol—15mL (w. applicator)

LAST UPDATED:

11/26/2012