{"effective_time":"20140811","id":"853a9772-976e-4e61-adda-be512964c26e","openfda":{},"package_label_principal_display_panel":["Principal Display Panel NDC 43093-103-01 Rx only FusePaq™ Compounding Kit for Topical Ointment Store kit at room temperature, 15-30°C (59-86°F) MAXITRIL™ (erythromycin/bacitracin ointment - compounding kit) Description: This kit contains active and inactive bulk materials to compound an erythromycin/bacitracin zinc topical ointment. The included instructions describe how to prepare the compounded ointment. Active Ingredients: 0.31 g erythromycin, USP 28.35 g (1 oz) bacitracin zinc ointment, USP Inactive Ingredients: Mineral oil, USP Mixing jar Spatula Syringe Instructions CAUTION: For manufacturing, processing, or repacking. Federal law prohibits dispensing without prescription. U.S. Patents Pending Do not use if safety seal is broken Fusion Pharmaceuticals, LLC 768 Calle Plano Camarillo, CA 93012 CS56-A1 rev 1 Maxitril Box Erythromycin Label Insert Page 1 Insert Page 2 Bacitracin Display Panel Bacitracin Drug Facts Mineral Oil Display Panel"],"set_id":"9d70e7f2-fb49-4200-85f9-ae331e7f3ec2","spl_product_data_elements":["Maxitril Erythromycin/Bacitracin Ointment Erythromycin Erythromycin Erythromycin Erythromycin Bacitracin Zinc Bacitracin Zinc Bacitracin Zinc Bacitracin Petrolatum Light Mineral Oil Light Mineral Oil Light Mineral Oil"],"spl_unclassified_section":["Drug Label Do not use if seal is broken Erythromycin, USP Powder C 37 H 67 NO 13 CAS# 114-07-8 Net contents: 0.31 g Caution: For manufacturing, processing, or repacking Repackaged by Fusion Pharmaceuticals, LLC, Camarillo, CA 93012 CS53-A1 rev 1","Instructions Insert NDC 43093-103-01 Rx only FusePaq™ MAXITRIL™ (erythromycin/bacitracin ointment - compounding kit) FusePaq™ compounding kits provide a convenient approach to rapidly compound prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practice (cGMP). For Prescription Compounding Only Description: This kit contains active and inactive bulk materials to compound an erythromycin/bacitracin zinc topical ointment. These instructions describe how to prepare approximately 30 grams of ointment. Active Ingredients: 0.31 g erythromycin, USP 28.35 g (1 oz) bacitracin zinc ointment, USP Inactive Ingredients: Mineral oil, USP Mixing jar Spatula Syringe Instructions Instructions for Compounding 1 Remove and Inspect the Contents of the Kit Ensure that all components are present. Verify that the mixing jar containing the erythromycin is fully sealed. If components are missing or the mixing jar is not sealed, do not use the kit. 2 Prepare for Mixing Wear gloves and eye protection during compounding operations. Break the seal on the erythromycin mixing jar. Remove the bacitracin zinc ointment tube from its box. Remove the syringe from its packaging. 3 Dissolve the Erythromycin Open the mineral oil bottle and the erythromycin jar. Using the syringe, withdraw 3 mL of mineral oil. Transfer the 3 mL mineral oil to the erythromycin jar. Using the spatula, mix the mineral oil and the erythromycin powder. Stir the mixture until the erythromycin is fully dissolved. 4 Complete the Mixing Process Squeeze the entire contents of the bacitracin zinc ointment tube into the mixing jar. Using the spatula, mix the contents. Vary the mixing direction to ensure that the ointment is mixed homogeneously and that all parts of the ointment are included in the mixing process. Homogeneity of the resulting ointment is dependent upon the thoroughness of the mixing process. 5 Re-label the Compounded Ointment Label the compounded ointment per the pharmacy's standard practice. Remove or obscure the erythromycin label, since the label is no longer accurate once compounding is completed. Discard the remaining mineral oil. Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the compounded ointment between 15-30°C (59-86°F). U.S. Patents Pending Manufactured by: Fusion Pharmaceuticals, LLC 768 Calle Plano Camarillo, CA 93012 CS54-A1 rev 1","Bacitracin Display Panel E. FOUGERA & CO. A division of Nycomed US Inc., Melville, New York 11747 Bacitracin Zinc Ointment USP First Aid Antibiotic NET WT 28.35G (1 Oz)","Bacitracin Drug Facts NDC 0168-0011-31 Bacitracin Zinc Ointment USP Drug Facts Active ingredient (in each gram) Purpose Bacitracin Zinc (equal to 500 bacitracin units) Antibiotic Uses first aid to help prevent infection in minor cuts scrapes burns Warnings For external use only Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns When using this product do not use longer than 1 week unless directed by a doctor Stop use and ask a doctor if the condition persists or gets worse if a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage Other information do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal store at room temperature see crimp of tube for Lot No. and Exp. Date Inactive ingredient white petrolatum Questions or comments? call toll free 1-800-645-9833","Mineral Oil Display Panel Topical Light Mineral Oil USP (sterile) NOT FOR PARENTERAL USE not intended for oral internal use 25mL THIS PRODUCT IS INTENDED FOR USE AS A TOPICAL LUBRICANT OR TOPICAL DRESSING Stabilized with Vitamin E CONTENTS STERILE UNLESS SEAL IS OPENED OR DAMAGED NDC 54162-185-25 Geritrex Corp: 144 Kingsbridge Road East, Mount Vernon, NY 10550 T: 914.668.4003 F: 914.668.4047 info@geritrex.com | www.geritrex.com"],"version":"8"}