UREA- urea suspension
Exact-Rx, Inc.
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.
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DESCRIPTION: Each gram of Urea Topical Suspension 50% contains urea 50% 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:
CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, which then softens the hyperkeratotic areas.
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 purulent 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, devitalized, and ingrown nails.
PRECAUTIONS: 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: 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. Urea Topical Suspension 50% should be given to pregnant women 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 Urea Topical Suspension 50% is administered to nursing women.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
Call your doctor for medical advice about side effects.
DOSAGE AND ADMINISTRATION: Apply Urea Topical Suspension 50% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.
HOW SUPPLIED: Urea Topical Suspension 50%, NDC # 42808-0201-10, is supplied in a 10 oz (283.5 g) tube.
UREA
urea suspension |
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Labeler - Exact-Rx, Inc. (137953498) |