X-Viate

X-VIATE- urea gel
Stratus Pharmaceuticals, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx only

For external use only.

Not for ophthalmic use.

DESCRIPTION

X-VIATE ™ is a potent keratolytic emollient which is a gentle tissue softener for skin and/or nails.

Each gram of X-VIATE40% CREAM contains 40% Urea in a cream base of Carbopol, Cetyl Alcohol, Glyceryl Monostearate, Light Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, White Petrolatum and Xanthan Gum.

Each gram of X-VIATE40% LOTION contains 40% Urea in a lotion base of Carbopol, Cetyl Alcohol, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Propyl Paraben, Propylene Glycol, Purified Water, Trolamine, White Petrolatum and Xanthan Gum.

Each gram of X-VIATE40% GEL contains 40% Urea in a gel base of Hydroxyethyl Cellulose, Methyl Paraben, Propylene Glycol and Purified Water.

CHEMISTRY

Urea is a diamide of carbonic acid with the following chemical structure:

Chemical StructureChemical Structure

CLINICAL PHARMACOLOGY

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS

The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES:

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

WARNINGS

For external use only. Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS

If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

PREGNANCY

Pregnancy Category B

Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, X-VIATE ™should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when X-VIATE ™ is administered to a nursing woman.

Adverse Reactions to X-Viate

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

DOSAGE AND ADMINISTRATION

Apply X-VIATE ™ to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.

HOW SUPPLIED

X-VIATE40% CREAM (40% Urea) is supplied in:

28.5g (1 oz) tube 58980-625-10
85g (3 oz) tube 58980-625-30
199g (7 oz) tube 58980-625-70

X-VIATE40% LOTION (40% Urea) is supplied in:

237mL (8 oz) bottle 58980-623-80

X-VIATE40% GEL (40% Urea) is supplied in:

15mL bottle 58980-624-15

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

Distributed by:
Stratus Pharmaceuticals Inc,
Miami, Florida 33186-6727
Toll free: 800-442-7882
www.stratuspharmaceuticals.com

Manufactured by:
Sonar Products, Inc., Carlstadt, NJ 07072

PG-KVG-IN 2009-0608

PRINCIPAL DISPLAY PANEL — 15 mL Bottle Carton

X-VIATE 40% GEL

NDC 58980-624-15

X-VIATE™ 40% GEL

Gentle, potent,
tissue softener,
for nail and skin

Rx only

UREA 40% IN A GEL BASE

Distributed by
STRATUS

NET WT 15 mL Bottle
with Applicator Brush

PRINCIPAL DISPLAY PANEL -- 15 mL Bottle Carton
(click image for full-size original)
X-VIATE
urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-624
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea (Urea) Urea 6.726 g in 15 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400
Methylparaben
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58980-624-15 1 VIAL, GLASS (VIAL) in 1 BOX contains a VIAL, GLASS
1 15 mL in 1 VIAL, GLASS This package is contained within the BOX (58980-624-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/03/2006
Labeler — Stratus Pharmaceuticals, Inc (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products Inc 104283945 MANUFACTURE (58980-624)

Revised: 10/2011 Stratus Pharmaceuticals, Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2019. All Rights Reserved.