{"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."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients."],"description":["DESCRIPTION Each mL of Kerol TM AD contains 45% urea in a formulation consisting of: propylene glycol, caprylic/capric triglycerides, polyethylene glycol 300, purified water, trolamine, vitamin E acetate, lactic acid, glycerin, polysorbate-60, linoleic acid, sorbitan monostearate, zinc undecylenate, titanium dioxide, cetyl alcohol, EDTA disodium, hydroxyethyl cellulose and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: Urea chemical structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply Kerol TM AD to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed."],"effective_time":"20120717","how_supplied":["HOW SUPPLIED Kerol TM AD (45% urea emulsion) is supplied as: 240 mL bottle, NDC 10337-643-24 Store at 15˚-30˚ C (59˚- 86˚ F). Protect from freezing. Mfd. for: PharmaDerm ® A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com Mfd. by: Pegasus Laboratories, Inc. Pensacola, FL 32514 IF643 R5/09"],"id":"37470aff-385c-4246-9fd3-02ca1cd43427","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 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."],"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 Kerol TM AD is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 240 mL CONTAINER LABEL NDC 10337-643-24 PharmaDerm ® NDC 10337-643-24 Rx only KEROL ™ AD (45% urea emulsion) Accu-Dose In a zinc undecylenate and lactic acid vehicle For Topical Use Only Net Content 240 mL PRINCIPAL DISPLAY PANEL – 240 mL CONTAINER LABEL","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 240 mL CARTON PharmaDerm ® NDC 10337-643-24 Rx only KEROL ™ AD (45% urea emulsion) Accu-Dose In a zinc undecylenate and lactic acid vehicle For Topical Use Only Net Content 240 mL PRINCIPAL DISPLAY PANEL – 240 mL 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."],"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, Kerol TM AD should be given to a pregnant woman only if clearly needed."],"set_id":"4a2f6c83-637b-45e4-9886-260726115c10","spl_patient_package_insert":["How to use Rx only Kerol™ AD (45% urea emulsion) Accu-Dose In a zinc undecylenate and lactic acid vehicle Steps for using Kerol AD to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema, corns and calluses. Kerol AD can be applied directly to the treatment area(s) without pouring from a bottle or squeezing from a tube. The pump is designed to consistently deliver a precise amount of Kerol AD with each use once the pump has been primed and medication is delivered to the spout. To begin using Kerol AD: Remove the cap. With the first use , prime the chamber by pushing the pump top all the way down and then release. Repeat this four to six times until the chamber inside is filled and the Kerol AD passes through the spout. * To use after the chamber is filled, push the pump top all the way down to dispense one dose of Kerol AD. A precise amount of Kerol AD will be consistently delivered with each use. Apply Kerol AD to the affected area(s). Gently massage Kerol AD into the affected area twice a day or as directed by your physician. Keep Kerol AD away from the eyes, lips or mucous membranes. Replace the cap. * Sample bottles of Kerol AD have a different fill ratio and will need to be pumped eight to ten times to prime the chamber and get the Kerol AD to pass through the spout."],"spl_product_data_elements":["Kerol AD urea urea urea propylene glycol polyethylene glycol 300 water trolamine alpha-tocopherol acetate lactic acid glycerin polysorbate 60 linoleic acid sorbitan monostearate zinc undecylenate titanium dioxide cetyl alcohol edetate disodium xanthan gum"],"spl_unclassified_section":["For external use only. Not for ophthalmic use. Rx only"],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}