Generic Name: urea lotion
Dosage Form: lotion
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 Lotion (35% Urea) In a vehicle containing Vitamin E, Lactic Acid and Zinc
Urealac (35% Urea) LOTION is a keratolytic emollient, which is a gentle, yet potent, tissue softener for skin. Each gram of Urealac lotion contains: 35% Urea, Carbomer, Cetyl Alcohol, Edetate Disodium, Hydroxyethyl Cellulose, Lactic Acid, Mineral Oil, Polysorbate 80, Purified Water, Sorbitan Stearate, Trolamine, Vitamin E, Xanthan Gum, Zinc Pyrion.
Urea is a diamide of carbonic acid with the following chemical structure:
Urealac - 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
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.
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 reproductive studies are not always predictive of human response, Urealac (35% Urea) LOTION 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 Urealac (35% Urea) LOTION 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.
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010.
Urealac Dosage and Administration
Apply Urealac (35% Urea) LOTION to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.
How is Urealac Supplied
Urealac (35% Urea) LOTION
7 oz. (207 mL) bottle
11 oz. (325 mL) bottle
Store at controlled room temperature 15°-30° C (59°-86° F).
Protect from freezing.
How to properly use Urealac LOTION (35% Urea)
Gentle keratolytic for mild to moderate dry skin and nail conditions.
Easy steps to gently thin and soften thick, rough or dry skin seen, to various degrees, in psoriasis, xerosis, ichthyosis, keratosis, keratoderma, dermatitis, pruritus, eczema and calluses.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Urealac Lotion (35% Urea)
In a vehicle containing Vitamin E, Lactic Acid, and Zinc
For Topical Use Only
7 oz. (207 mL)
|Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)|
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