NUVAIL- lauric acid liquid 
EPI Health, Inc

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Nuvail™
(poly-ureaurethane, 16%)

NAIL SOLUTION

Rx Only

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 non-cytotoxic 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

HOW SUPPLIED

Nuvail Nail Solution is supplied in a:

15 ml non-sterile bottle with applicator 71403-044-01.

STORAGE AND SHELF LIFE

For best results the product should be stored at room temperature (15° to 30°C, 59° to 86°F).

Avoid storage in excessive heat and humidity. Refer to the bottle label for expiration date.

Manufactured for:
EPI Health, LLC
Charleston, SC 29403
Toll Free: 1-800-499-4468

www.nuvail-rx.com

N. Code : HR/DEVICE/MFG/MD/2018/000004
Made in India

December 2018

This product may be covered by one or more of the US Patent Nos. 7,008,997/8,771,725/9,259,436.

NUV-PI-0617

Version - 1

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

71403-044-01

Rx Only
Nuvail™
(poly-ureaurethane, 16%)
NAIL SOLUTION

For Topical Use Only
Not For Ophthalmic Use

EPIHEALTH
Advancing Dermatology

15 mL

Principal Display Panel - 15 mL Bottle Carton
NUVAIL 
bandage, liquid liquid
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:71403-044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAURIC ACID (UNII: 1160N9NU9U) (LAURIC ACID - UNII:1160N9NU9U) LAURIC ACID2.4 mg  in 15 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:71403-044-0115 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
PREMARKET NOTIFICATIONK12005905/01/2017
Labeler - EPI Health, Inc (080638894)

Revised: 1/2019
Document Id: 39ecd82c-40f1-4c57-8ccf-31a37d60a8d4
Set id: 1bc17c4d-3bdf-460c-8993-781953c436f6
Version: 3
Effective Time: 20190117
 
EPI Health, Inc