{"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."],"contraindications":["CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients."],"description":["DESCRIPTION: CARMOL ® 40 is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of CARMOL ® 40 (40% Urea) Cream and CARMOL ® 40 (40% Urea) Lotion consists of 40% urea in a vehicle containing carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, triethanolamine and xanthan gum. Each gram of CARMOL ® 40 (40% Urea) GEL consists of 40% urea in a vehicle containing disodium EDTA, glycerin, hydroxyethylcellulose, PEG-6 caprylic/capric glycerides, purified water and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: chemical structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Apply CARMOL ® 40 to affected skin 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. Let dry uncovered or apply and cover with adhesive bandage or gauze secured with adhesive tape."],"effective_time":"20120426","how_supplied":["HOW SUPPLIED: CARMOL ® 40 (40% Urea) is supplied as: CARMOL ® 40 Lotion: 236.6 mL (8 fl oz) bottle, NDC 10337-656-51 CARMOL ® 40 Cream: 28.35 g (1 oz) tube, NDC 10337-652-52 85 g (3 oz) tube, NDC 10337-652-19 198.6 g (7 oz) tube, NDC 10337-652-49 CARMOL ® 40 Gel: 15 mL (1/2 oz) bottle, NDC 10337-657-15 Store at Controlled Room Temperature 15°-30°C (59°-86°F). Protect from freezing. Manufactured for: DERM/arts® Division DOAK DERMATOLOGICS A Subsidiary of Bradley Pharmaceuticals, Inc. 383 Route 46 West Fairfield, NJ 07004-2402 USA 1-800-405-DOAK www.doakderm.com Manufactured by: Groupe PARIMA, Inc. Montreal, QC, H4S 1X6 CANADA Reg. U.S. Patent Nos. 5,919,470 6,380,236 6,281,239 IL181-R4 Rev 09/06"],"id":"09699378-2202-4c95-9ac1-1f97e0e4acd6","indications_and_usage":["INDICATIONS AND USAGE: 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."],"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 CARMOL ® 40 is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 236.6 mL CONTAINER NDC 10337-656-51 Rx Only CARMOL ® 40 (40% Urea) Lotion Gentle, Yet Potent, Skin Softening Lotion For Topical Use Only DIRECTIONS: Apply CARMOL ® 40 to affected area(s). Rub in until lotion is completely absorbed. 8 fl. oz. (236.6mL) DOAK DERMATOLOGICS PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 236.6 mL CONTAINER","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 236.6 mL CARTON NDC 10337-656-51 Rx Only CARMOL ® 40 (40% Urea) Lotion For Topical Use Only Gentle, Yet Potent, Skin Softening Lotion No AT Rated Bio- Equivalent 8 fl. oz. (236.6mL) DOAK DERMATOLOGICS PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 236.6 mL CARTON","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 g CONTAINER DIRECTIONS: For use on skin and nail. See box or insert for instructions. Use only as directed by a physician. NDC 10337-652-52 Rx Only CARMOL ® 40 (40% Urea) Cream Potent, yet gentle, tissue softener NET WT. 1oz. (28.35g) Manufactured for: DERM/arts DIVISION DOAK DERMATOLOGICS IT023-R5 FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 g CONTAINER","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 g CARTON NDC 10337-652-52 Rx Only CARMOL ® 40 (40% Urea) Cream NET WT. 1oz. (28.35 g) For Topical Use Only Potent, yet gentle, tissue softener No AT Rated Bio- Equivalent DOAK DERMATOLOGICS PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 28.35 g CARTON","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 mL CONTAINER NDC 10337-657-15 Rx Only CARMOL ® 40 (40% Urea) GEL 15 mL Store at controlled room temperature 15°-30°C (59°-85°F). Protect from freezing. DOAK DERMATOLOGICS PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 mL CONTAINER","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 mL CARTON NDC 10337-657-15 Rx Only CARMOL ® 40 (40% Urea) GEL Potent tissue softener for nails and skin For Topical Use Only 15 mL Bottle plus Applicator Brush No AT Rated Bio- Equivalent DOAK DERMATOLOGICS PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 mL CARTON"],"pediatric_use":["KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"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."],"set_id":"bfe02a79-b16f-42e4-9b95-10a6a72e2b59","spl_product_data_elements":["Carmol 40 urea UREA UREA CETYL ALCOHOL GLYCERYL MONOSTEARATE MINERAL OIL PETROLATUM PROPYLENE GLYCOL WATER TROLAMINE XANTHAN GUM Carmol 40 urea UREA UREA CETYL ALCOHOL GLYCERYL MONOSTEARATE MINERAL OIL PETROLATUM PROPYLENE GLYCOL WATER TROLAMINE XANTHAN GUM Carmol 40 urea UREA UREA EDETATE DISODIUM GLYCERIN WATER XANTHAN GUM"],"spl_unclassified_section":["For external use only. Not for ophthalmic use."],"version":"3","warnings":["WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes."],"warnings_and_cautions":["WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes. 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 reproduction studies are not always predictive of human response, CARMOL ® 40 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 CARMOL ® 40 is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."]}