{"adverse_reactions":["Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication."],"clinical_pharmacology":["URE-39 - 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 URE-39 Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients."],"description":["URE-39 Description URE-39 Cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails. Each gram of URE-39 Cream contains: ACTIVE: 39% Urea in a cream base of: INACTIVES: Deionized Water, Carthamus Tinctorius (Safflower) Seed Oil, Emulsifying Wax, Glycerine, Propylene Glycol, Glyceryl Stearate, PEG 100 Stearate, Cetyl Alcohol, Dimethicone, C12/15 Alkyl Benzoate, Anthemis Nobilis (Chamomile) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, and Isobutylparaben. CHEMISTRY Urea is a diamide of carbonic acid with the following chemical structure: Chemical Structure"],"dosage_and_administration":["URE-39 - Dosage and Administration Apply URE-39 Cream to affected skin two to three times per day as needed or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue two to three times per day or as directed by a physician. Best applied to affected areas immediately after showering and just before bedtime."],"effective_time":"20180314","how_supplied":["How is URE-39 Supplied URE-39 ( 39% Urea Cream) is supplied in: 8oz (227gm) Jar NDC: 70350-2612-1 Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.]"],"how_supplied_table":["
8oz (227gm) Jar NDC: 70350-2612-1
"],"id":"d11226bd-6486-4a59-bb3b-831df2e4b4bf","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 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, as well as damaged, ingrown and devitalized nails."],"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 URE-39 Cream is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 227 gm Jar Label NDC 70350-2612-1 FOR TOPICAL USE ONLY URE-39 UREA 39% CREAM Smooth Easily Spreadable Rx only Solu tech PHARMACEUTICALS Net WT. 8OZ (227 gm) PRINCIPAL DISPLAY PANEL - 227 gm Jar Label"],"pharmacokinetics":["PHARMACOKINETICS The mechanism of action of topically applied Urea is not yet known."],"precautions":["Precautions Stop use and ask a doctor if redness or irritation develops. After applying this medication, wash hands and unaffected areas thoroughly. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. 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, URE-39 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 URE-39 Cream is administered to a nursing woman."],"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 reproduction studies are not always predictive of human response, URE-39 Cream should be given to a pregnant woman only if clearly needed."],"set_id":"ecf5d277-b1f6-495f-9f08-204217bef84e","spl_product_data_elements":["URE-39 UREA UREA UREA WATER SAFFLOWER OIL GLYCERIN PROPYLENE GLYCOL GLYCERYL MONOSTEARATE PEG-100 STEARATE CETYL ALCOHOL DIMETHICONE ALKYL (C12-15) BENZOATE CHAMAEMELUM NOBILE FLOWER TEA TREE OIL ALOE VERA LEAF PHENOXYETHANOL METHYLPARABEN ETHYLPARABEN BUTYLPARABEN PROPYLPARABEN ISOBUTYLPARABEN"],"spl_unclassified_section":["Rx only For external use only. Not for ophthalmic use.","Manufactured for: Solutech Pharmaceuticals LLC Peoria, AZ 85345 Rx only"],"storage_and_handling":["Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.]"],"version":"1","warnings":["Warnings For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin."]}