{"adverse_reactions":["ADVERSE REACTIONS Transient stinging, burning, itching or irritation may occur and will normally disappear upon discontinuing the use of this product."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term animal studies for carcinogenic potential have not been performed on this product. Studies on reproduction and fertility also have not been performed."],"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 of the skin. Pharmacokinetics The mechanism of action of topically applied urea is not yet known."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in people with known or suspected hypersensitivity to any of the ingredients of the product."],"description":["DESCRIPTION Each gram contains 400 mg of urea in a vehicle of carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide, and xanthan gum. Urea is a diamide of carbonic acid with the chemical structure: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician."],"effective_time":"20250821","general_precautions":["General This product 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 and consult a physician."],"how_supplied":["HOW SUPPLIED 28.35 g (1 oz.) bottles, NDC 39328-019-01 85 g (3 oz.) bottles, NDC 39328-019-03 198.4 g (7 oz.) bottles, NDC 39328-019-07"],"id":"2a3a53e2-6a1d-4422-b058-c9799cb3fa79","indications_and_usage":["INDICATIONS 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, as well as damaged, ingrown and devitalized nails."],"information_for_patients":["Information for Patients Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes."],"nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman."],"openfda":{"brand_name":["Urea 40%"],"generic_name":["UREA"],"is_original_packager":[true],"manufacturer_name":["Patrin Pharma, Inc"],"package_ndc":["39328-019-01","39328-019-03","39328-019-07"],"product_ndc":["39328-019"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"rxcui":["198342"],"spl_id":["2a3a53e2-6a1d-4422-b058-c9799cb3fa79"],"spl_set_id":["53ccf801-c1c6-42c8-a511-da33c308076f"],"substance_name":["UREA"],"unii":["8W8T17847W"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 28.35 g Bottle Carton NDC 39328-019-01 Urea 40% Topical Cream For External Use Only Not for Ophthalmic Use Rx Only Net Wt. 28.35 g (1 oz.) PATRIN PHARMA Chemical Structure"],"pharmacokinetics":["Pharmacokinetics The mechanism of action of topically applied urea is not yet known."],"precautions":["PRECAUTIONS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General This product 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 and consult a physician. Information for Patients Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term animal studies for carcinogenic potential have not been performed on this product. Studies on reproduction and fertility also have not been performed. Pregnancy Category C Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman."],"pregnancy":["Pregnancy Category C Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus."],"set_id":"53ccf801-c1c6-42c8-a511-da33c308076f","spl_product_data_elements":["Urea 40% Urea Urea Urea CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE Cetyl alcohol Dimethyl isosorbide Glyceryl monostearate Mineral oil Petrolatum Propylene glycol Water Sodium Hydroxide Xanthan gum"],"spl_unclassified_section":["Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.","To report SUSPECTED ADVERSE REACTIONS, contact Patrin Pharma at 1-800-936-3088 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch for voluntary reporting of suspected adverse reactions. Made in the USA Manufactured for: Patrin Pharma Skokie, IL 60076 Questions (800) 936 3088 Rev 01.0525"],"storage_and_handling":["STORAGE Store at 20–25°C (68–77ºF), excursions permitted to 15–30ºC (59–86ºF). Protect from freezing and excessive heat. Keep bottle tightly closed"],"version":"1","warnings":["WARNING KEEP OUT OF REACH OF CHILDREN."]}