X-Viate

Generic Name: urea
Dosage Form: cream, lotion, gel

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.

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)

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.

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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:

X-Viate - 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

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 is X-Viate Supplied

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

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

X-Viate™ 40% 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
Tollfree: 800-442-7882
www.stratuspharmaceuticals.com

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

PG-XVG-IN 2009-0608

PRINCIPAL DISPLAY PANEL - 199g Tube Carton

X-Viate 40% CREAM

NDC 58980-625-70

X-Viate™

40%
CREAM

Softens and
Moisturizes
Severe
Dry
Skin

Rx only

UREA 40%
IN A CREAM BASE

Distributed by:
STRATUS
PHARMACEUTICALS INC

NET WT 7 oz (199g)

X VIATE 
urea cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-625
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea (Urea) Urea 0.4 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
Cetyl Alcohol  
Glyceryl Monostearate  
Light Mineral Oil  
Propylene Glycol  
Water  
Sodium Hydroxide  
Petrolatum  
Xanthan Gum  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:58980-625-10 1 TUBE (TUBE) in 1 BOX
1 28.3 g in 1 TUBE
2 NDC:58980-625-30 1 TUBE (TUBE) in 1 BOX
2 85 g in 1 TUBE
3 NDC:58980-625-70 1 TUBE (TUBE) in 1 BOX
3 199 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/11/2005
Labeler - Stratus Pharamceuticals, Inc (789001641)
Registrant - Sonar Products, Inc (104283945)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE
Revised: 10/2010
 
Stratus Pharamceuticals, Inc
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