Urealac Topical Suspension
Generic Name: lactic acid and salicylic acid
Dosage Form: topical suspension
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.
Urealac Topical Suspension (50% Urea) in a lactic acid & salicylic acid vehicle
Urealac Topical Suspension Description
Each gram of Urealac Topical Suspension contains 50% urea in a formulation consisting of caprylic/capric triglyceride carbomer, cetyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, lactic acid, PEG- 8, polysorbate 60, propylene glycol, purified water, salicylic acid, sorbitan stearate, titanium dioxide, triethanolamine, vitamin E and xathan gum.
UREA is a diamide of carbonic acid with the following chemical structure:
Urealac Topical Suspension - 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.
Indications and Usage for Urealac Topical Suspension
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous 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 than 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. Urealac Topical Suspension should be given to a pregnant women 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 Urealac Topical Suspension is administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Urealac Topical Suspension Dosage and Administration
Apply Urealac Topical Suspension to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.
How is Urealac Topical Suspension Supplied
Urealac Topical Suspension (50% Urea) is supplied as:
284 g (10 oz) tube.
Store at controlled room temperature 15°-30°C (59°-86°F).
Protect from freezing.
Easy steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema, corns and calluses.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Urealac Topical Suspension
(50% Urea) In a lactic acid & salicylic acid vehicle
For Topical Use Only
Net Wt. 10 oz. (284 g)
|Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)|