Nuvail

Manufacturer
Innocutis Holdings LLC
Effective date
2013-02-11
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:47:39

Label at a glance#

ProductNuvail
Label structure9 sections

Dosage and administration

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

Storage and handling

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.

Label contents#

Full prescribing information#

Intended Use

INTENDED USE OF THE DEVICE

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

DESCRIPTION SECTION

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

INACTIVE INGREDIENT SECTION

16% Poly (urea-urethane) in organic solvents

Contraindications

CONTRAINDICATIONS SECTION

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

Warnings and Precautions

WARNINGS AND PRECAUTIONS SECTION

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

INDICATIONS & USAGE SECTION


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

HOW SUPPLIED SECTION

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

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68712-044-01Nuvail15 mL in 1 BOTTLE, GLASS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68712-044NUVAIL () [INNOCUTIS HOLDINGS LLC]21 package rows20130212_c8bb98ea-cefe-4fae-adf8-3ab9e56f164c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68712-044-01ML - Milliliter68712-0448c17ce27-6a44-4e95-9c1d-c86986597faf12013-02-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68712-04468712-044-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.