X-Viate

Stratus Pharmaceuticals, Inc

X-VIATE™ 40% CREAM (Urea 40% in a cream base) X-VIATE™ 40% LOTION (Urea 40% in a lotion base) X-VIATE™ 40% GEL (Urea 40% in a gel base)

FULL PRESCRIBING INFORMATION: CONTENTS*

• X-VIATE DESCRIPTION
  • CHEMISTRY
• CLINICAL PHARMACOLOGY
  • PHARMACOKINETICS
• INDICATIONS AND USES:
• X-VIATE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • PREGNANCY
  • NURSING MOTHERS
• X-VIATE ADVERSE REACTIONS
• X-VIATE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

FULL PRESCRIBING INFORMATION

Rx only

For external use only.

Not for ophthalmic use.

X-VIATE DESCRIPTION

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

Each gram of X-VIATE™ 40% 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-VIATE™ 40% 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-VIATE™ 40% 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:

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.

X-VIATE 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.

X-VIATE ADVERSE REACTIONS

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

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

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

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

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