X
urea
Dosage Form: gel
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 Gel 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:
X-Viate Gel - 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 Gel 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 Gel 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
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
X-VIATE
urea gel
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
NDC Product Code (Source)
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
Product Characteristics
Color
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
58980-624-15
1 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
Revised: 10/2011Stratus Pharmaceuticals, Inc
More X-Viate Gel resources
X-Viate Gel Side Effects (in more detail)X-Viate Gel Use in Pregnancy & BreastfeedingX-Viate Gel Support Group2 Reviews for X-Viate - Add your own review/rating
Compare X-Viate Gel with other medications
Dermatological DisordersDry SkinPityriasis rubra pilaris
X Viate Gel
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