{"contraindications":["CONTRAINDICATIONS VERRUNEX® Topical Cream, as dispensed, is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation."],"description":["DESCRIPTION VERRUNEX® is comprised of 0.5 g of Fluorouracil USP and 1.2 g of Salicylic Acid USP, for dermatological use. VERRUNEX® also contains a Cream Base containing purified water, white petrolatum, sorbitol solution, cetearyl alcohol, propylene glycol, ceteareth-20, simethicone, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid and BHT. When mixed as instructed, the final product provides a homogeneous cream mixture containing Fluorouracil, and Salicylic Acid comparable to the active ingredients (Efudex® 5% and Compound W® 17%) contained in VERRUNEX®. Certificate of analysis on file This product is not manufactured by Valeant Pharmaceuticals, manufacturer of Efudex®, or by Prestige Brands Inc., manufacturer of Compound W®."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The pharmacist must mix contents of each container with appropriate amount of Cream Base yielding a final volume of 10 grams at the time of dispensing. Pharmacist may utilize appropriate diluents if needed from the respective active component Material Safety Data Sheet only. For dermatological use only. This product should not be administered orally, intravaginally or into the eyes. CAUTION: Observe and exercise appropriate precautions for handling, preparing, and administering cytotoxic drugs."],"drug_interactions":["DRUG INTERACTIONS Consult your pharmacist. Keep a list of all your medications with you, and share the list with your doctor and pharmacist."],"effective_time":"20150721","how_supplied":["HOW SUPPLIED VERRUNEX® Cream, as dispensed, is supplied as a four component package: two containers which contain the active components Fluorouracil 0.5 g and Salicylic Acid 1.2 g (respectively), a separate package of Cream Base and a stirring apparatus. The pharmacist must mix contents of each active component container with appropriate amount of Cream Base such that the QS volume yields 10 grams (final weight) at the time of dispensing. Pharmacist may utilize appropriate diluents if needed from the respective active component Material Safety Data Sheet only. Pharmacist must only use appropriate amount of Cream Base such that the final volume yields 10 grams inclusive of all drug substances, any diluents that may have been added, and Cream Base. Pharmacist may dispense final product upon reconstituting and mixing into a dispensing container of their choice or as directed by prescriber. Mix for 5 minute before dispensing. May use a mixing aid, if necessary. Shake well before using. Store between 15° and 30°C (59° and 86°F) in tightly closed containers prior to mixing. Store final product at refrigerated temperature, 2°-8°C (36°-46°F). For dermatological use only. Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Protect from light. Protect from freezing. VERRUNEX® Cream, as dispensed, is stable for at least 30 days at refrigerated temperature upon mixing as recommended under USP 795 Guidelines. U.S. Patent Pending Distributed By: Accumix Pharmaceuticals East Windsor, NJ 08520 CAUTION: Observe and exercise appropriate precautions for handling, preparing, and administering cytotoxic drugs Rx ONLY For External Use Only Issued: October 2014 v1"],"how_supplied_table":["<table styleCode=\"Noautorules\" width=\"500\"> <tbody> <tr> <td styleCode=\"bold Toprule Botrule Rrule Lrule\">CAUTION: Observe and exercise appropriate precautions for handling, preparing, and administering cytotoxic drugs</td> </tr> </tbody> </table>"],"id":"8760397f-4c0b-476d-819e-b64f5acce6ad","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - NDC: 69167-3255-1 - Carton Label Verrunex Topical Cream Carton Label"],"precautions":["PRECAUTIONS Consult your pharmacist."],"set_id":"4633289c-a36e-481e-969d-43a460071067","spl_product_data_elements":["Verrunex fluorouracil and salicylic acid Fluorouracil fluorouracil FLUOROURACIL FLUOROURACIL Salicylic Acid salicylic acid SALICYLIC ACID SALICYLIC ACID Cream Base cream WATER PETROLATUM SORBITOL CETOSTEARYL ALCOHOL PROPYLENE GLYCOL POLYOXYL 20 CETOSTEARYL ETHER DIMETHICONE GLYCERYL MONOSTEARATE POLYETHYLENE GLYCOLS SORBIC ACID BUTYLATED HYDROXYTOLUENE"],"spl_unclassified_section":["USES Consult your pharmacist.","HOW TO USE Consult your pharmacist.","SIDE EFFECTS Consult your pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.","MISSED DOSE Consult your pharmacist.","NOTES No Monograph available at this time."],"version":"2"}