{"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. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate. PHARMACOKINETICS The mechanism of action of topically applied Urea is not yet known."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients."],"description":["DESCRIPTION Uramaxin ® (45% Urea) Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Uramaxin ® (45% Urea) Cream contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water. Urea is a diamide of carbonic acid with the following chemical structure: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply Uramaxin ® (45% Urea) Cream to affected skin twice per day, or as directed by a physician. Apply to diseased or damaged nails twice per day, or as directed by a physician."],"effective_time":"20171110","how_supplied":["HOW SUPPLIED Uramaxin ® (45% Urea) Cream 9 oz. tube, NDC 43538-210-09 Store at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing."],"id":"536ad409-a47c-41bc-a2e7-ff2f9074ad99","indications_and_usage":["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."],"nonteratogenic_effects":["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, Uramaxin ® (45% Urea) Cream should be given to a pregnant woman only if clearly needed."],"nursing_mothers":["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 Uramaxin ® (45% Urea) Cream is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 255 g Carton NDC 43538-210-09 Rx Only Uramaxin ® (45% UREA) CREAM In a vehicle containing Menthol, Camphor and Eucalyptus Oil FOR TOPICAL USE ONLY Net Wt. 9 oz (255 g) MEDIMETRIKS PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL - 255 g Carton"],"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. 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 reproductive studies are not always predictive of human response, Uramaxin ® (45% Urea) Cream should be given to a pregnant woman 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 Uramaxin ® (45% Urea) Cream is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"pregnancy":["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 reproductive studies are not always predictive of human response, Uramaxin ® (45% Urea) Cream should be given to a pregnant woman only if clearly needed."],"set_id":"442959cb-8c6d-47bc-ab51-9fae8990c246","spl_product_data_elements":["Uramaxin urea urea urea camphor (synthetic) edetate disodium eucalyptus oil MENTHOL, UNSPECIFIED FORM propylene glycol water"],"spl_unclassified_section":["Rx Only In a vehicle containing Menthol, Camphor and Eucalyptus Oil For external use only. Not for ophthalmic use.","Manufactured for: MEDIMETRIKS PHARMACEUTICALS, INC. 363 Route 46 West Fairfield, NJ 07004-2402 USA www.medimetriks.com Manufactured by: Groupe PARIMA, Inc. Montreal, QC H4S 1X6 CANADA IP002-R1 Iss. 7/09"],"storage_and_handling":["Store at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing."],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}