Label: X VIATE- urea cream
- NDC Code(s): 58980-625-10, 58980-625-30, 58980-625-70
- Packager: Stratus Pharamceuticals, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- SPL UNCLASSIFIED SECTION
For external use only.Close
Not for ophthalmic use.
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.Close
- 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.Close
- 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.Close
Known hypersensitivity to any of the listed ingredients.Close
For external use only. Avoid contact with eyes, lips or mucous membranes.Close
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 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.
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.Close
- 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.Close
- HOW 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
- SPL UNCLASSIFIED SECTION
Stratus Pharmaceuticals Inc,
Miami, Florida 33186-6727
Sonar Products, Inc., Carlstadt, NJ 07072
- PRINCIPAL DISPLAY PANEL - 199g Tube Carton
X-VIATE 40% CREAM
IN A CREAM BASE
NET WT 7 oz (199g)
- INGREDIENTS AND APPEARANCE
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 Marketing Start Date Marketing End Date 1 NDC:58980-625-10 1 in 1 BOX 1 28.3 g in 1 TUBE 2 NDC:58980-625-30 1 in 1 BOX 2 85 g in 1 TUBE 3 NDC:58980-625-70 1 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 Business Operations Sonar Products, Inc 104283945 MANUFACTURE