{"adverse_reactions":["Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication."],"clinical_pharmacology":["Pro-39 Urea - 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."],"contraindications":["Contraindications Pro-39 Urea Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients."],"description":["Pro-39 Urea Description Pro-39 Urea Cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails. Each gram of Pro-39 Urea Cream contains: ACTIVE: 39% Urea in a cream base of: INACTIVES: Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Propylene Glycol, Dimethicone, Melaleuca Alternifolia (Tea Tree) Oil, Helianthus Annuus (Sunflower) Oil, Chamomilla Recutita (Chamomile) Extract, Carbomer, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin. CHEMISTRY Urea is a diamide of carbonic acid with the following chemical structure: image description"],"dosage_and_administration":["Pro-39 Urea - Dosage and Administration Apply Pro-39 Urea 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":"20211018","how_supplied":["How is Pro-39 Urea Supplied Pro-39 Urea (39% Urea Cream) is supplied in: 8oz (227gm) Jar NDC 72678-034-01 Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.] Manufactured for: Lifsa Drugs LLC, New Brunswick, NJ 08901 Rx only"],"id":"cea2858e-66cc-16c0-e053-2a95a90ab774","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 Pro-39 Urea Cream is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["Packaging image"],"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 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, Pro-39 Urea Cream should be given to a pregnant woman only if clearly needed."],"set_id":"485e815f-ff7f-4a50-a0de-7b79024c8040","spl_product_data_elements":["Pro-39 Urea Urea WATER ALOE VERA LEAF PROPYLENE GLYCOL DIMETHICONE MELALEUCA ALTERNIFOLIA LEAF SUNFLOWER OIL CHAMOMILE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE PHENOXYETHANOL ETHYLHEXYLGLYCERIN UREA UREA"],"spl_unclassified_section":["Pro-39 Urea (Urea 39% Cream) Rx only For Topical Dermatological Use Only Rx Only - Caution: Federal Law restricts this product to sale by, or on the order of a licensed healthcare practitioner.","PRINCIPAL DISPLAY PANEL - 227 gm Jar Label Rx only NDC 72336-034-01 Pro-39 Urea UREA 39% CREAM Smooth, Spreadable, Moisturizing Pro-39’s high amount of urea exhibits intensive keratolyic and peeling effects. Thoroughly nourishes, helping to prevent cracks, and drying of your skin. FOR TOPICAL USE ONLY Net WT. 8OZ (227 gm)"],"version":"2","warnings":["Warnings For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin."]}