{"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 removal of devitalized nail plate tissue. 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 45% Urea Nil Gel is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of 45% Urea Nail Gel contains: 45% urea. Other ingredients: camphor, disodium EDTA, eucalyptus oil, hydroxyethylcellulose, 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 45% Urea Nail Gel to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician."],"effective_time":"20180103","how_supplied":["HOW SUPPLIED 45% Urea Nail Gel is supplied in 28 mL bottles, NDC 61269-181-28. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing."],"id":"79608f16-9a5c-457d-83e9-eb522dfcc077","indications_and_usage":["INDICATIONS AND USES 45% Urea Nail Gel is indicated for use in the topical treatment 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."],"nursing_mothers":["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 45% Urea Nail Gel is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 28 mL Bottle Carton NDC 61269-181-28 Rx Only 45% Urea Nail Gel In a vehicle containing Camphor, Eucalyptus Oil and Menthol FOR TOPICAL USE ONLY 28 mL Bottle with Applicator Brush H 2 pharma PRINCIPAL DISPLAY PANEL - 28 mL Bottle 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. If swallowed seek medical attention or contact a Poison Control Center immediately. 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, 45% Urea Nail Gel should be given to a pregnant woman 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 45% Urea Nail Gel 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, 45% Urea Nail Gel should be given to a pregnant woman only if clearly needed."],"set_id":"fa48f90f-842f-4831-93c8-d2513e99a3c3","spl_product_data_elements":["Urea Nail UREA UREA UREA CAMPHOR (SYNTHETIC) EDETATE DISODIUM EUCALYPTUS OIL HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER"],"spl_unclassified_section":["Rx Only For external use only. Not for ophthalmic use.","Manufactured for: H2-Pharma, LLC Montgomery, AL 36117 www.h2-pharma.com Rev. 10/16 181-28"],"storage_and_handling":["Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing."],"teratogenic_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, 45% Urea Nail Gel should be given to a pregnant woman only if clearly needed."],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucus membranes. Temporary stinging, burning, itching, or irritation may occur and normally disappear on discontinuation of the medication."]}