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(50% Urea) In a lactic acid & salicylic acid vehicle
For external use only.
Each gram of Latrix™ Topical Suspension contains: ACTIVE: 50% Urea in a topical suspension base of INACTIVES: consisting of Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Edetate Disodium, Glycerin, Hydroxyethylcellulose, Lactic Acid, Linoleic Acid, PEG-6, Polysorbate 60, Propylene Glycol, Purified Water, Salicylic Acid, Sorbitan Stearate, Titanium Dioxide, Trolamine, Vitamin E and Xanthan Gum.
Urea is a diamide of carbonic acid with the following chemical structure:
Urea gently dissolves the intercellular matrix, which results in loosening the homy layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.
INDICATIONS AND USES
For debridement and promotion of normal healing of hyperkeratolic surface lesions, particularly where healing is retarded by local infection, necrotic tissues, fibrinour or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis Palmaris, keratoderma, corns and calluses.
This medication is to be used as directed by a physician and should not be used to treat any condition other then that for which it was prescribed. If redness or irritation occurs, discontinue use.
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, Latrix™ Topical Suspension should be given to a pregnant woman only if clearly needed.
It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Latrix™ Topical Suspension is administered to a nursing woman.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
DOSAGE AND ADMINISTRATION
Apply Latrix™ Topical Suspension to the affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.
Latrix™ Topical Suspension (50% Urea) is supplied as:
PRINCIPAL DISPLAY PANEL - 284 g Carton
For Topical Use Only
Net Wt. 10 oz (284 g)
Revised: 10/2009 Stratus Pharmaceuticals, Inc
Reproduced with permission of U.S. National Library of Medicine
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