{"adverse_reactions":["ADVERSE REACTIONS Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication."],"clinical_pharmacology":["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."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients."],"description":["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: Urea Structural Formula"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply Urealac Topical Suspension to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed."],"effective_time":"20091103","how_supplied":["HOW 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."],"id":"1c8516b8-5647-4160-a9b6-cd4721fcb96c","indications_and_usage":["INDICATIONS AND USAGE 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."],"openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 50383-708-10 Urealac Topical Suspension (50% Urea) In a lactic acid & salicylic acid vehicle For Topical Use Only Rx Only Net Wt. 10 oz. (284 g) Tube - 10 oz","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 50383-707-10 Urealac Topical Suspension 50% Urea In a lactic acid and salicylic acid vehicle Rx Only For Topical Use Only Net Wt. 10 oz (284 g) Carton - 10 oz"],"pharmacokinetics":["PHARMACOKINETICS The mechanism of action of topically applied Urea is not yet known."],"precautions":["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."],"set_id":"fa74643c-6626-4cc0-9825-e563c189738b","spl_product_data_elements":["Urealac Urea UREA UREA CAPRYLIC/CAPRIC MONO/DIGLYCERIDES CARBOMER 934 CETYL ALCOHOL EDETATE DISODIUM GLYCERIN HYDROXYETHYL CELLULOSE (140 CPS AT 5%) LACTIC ACID POLYOXYL 8 STEARATE POLYSORBATE 60 PROPYLENE GLYCOL WATER SALICYLIC ACID SORBITAN MONOSTEARATE TITANIUM DIOXIDE TROLAMINE ALPHA-TOCOPHEROL SUCCINATE, D- XANTHAN GUM"],"spl_unclassified_section":["For external use only. Not for ophthalmic 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. UREALAC TOPICAL SUSPENSION should be given to a pregnant women only if clearly needed.","NURSING MOTHERS 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.","Easy steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema, corns and calluses. For skin: 1. Apply UREALAC TOPICAL SUSPENSION to affected skin twice per day, or as directed by a physician. 2. Rub in until completely absorbed. Rx Only Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, N.Y. 11701 MG #25570 Rev 707:00 01/08"],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}