{"description":["FOR PRESCRIPTION COMPOUNDING ONLY DESCRIPTION Gabapentin, Pentoxifylline, AmantadineHCL, Bupivacaine HCL, Diclofenac Sodium, Baclofen, Cyclobenzaprine HCL. Each Alvix- Gapeam Budibac Compounding Ingredients provides 16.5 grams of Gabapentin USP, 16.5 grams of Pentoxifylline USP, 13.2 grams of Amantadine HCL USP, 8.25 grams of Bupivacaine HCL USP, 4.9 grams of Diclofenac Sodium USP, 3.25 grams of Baclofen USP, 3.25 grams of Cyclobenzaprine HCL USP for incorporation into 99.15 grams of TDC Max Cream Base."],"effective_time":"20180312","id":"673dc8db-626f-c569-e053-2a91aa0ae7f6","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 15455-0717-1 RX ONLY Alvix-Gapeam Budibac™ Amantadine HCl, Baclofen, Bupivacaine HCl, Cyclobenzaprine HCl, Diclofenac Sodium, Gabapentin, and Pentoxifylline Compounding Ingredients FOR PRESCRIPTION COMPOUNDING ONLY 165 grams as dispensed Carton Label"],"set_id":"44c4d672-450a-434e-8b1f-6cc4b54916e3","spl_patient_package_insert":["PACKAGE INSERT Insert Page 1 Insert Page 2"],"spl_product_data_elements":["Gapeam Budibac Amantadine HCl, Baclofen, Bupivacaine HCl, Cyclobenzaprine HCl, Diclofenac Sodium, Gabapentin, and Pentoxifylline AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE AMANTADINE BACLOFEN BACLOFEN BACLOFEN BACLOFEN BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE ANHYDROUS BUPIVACAINE CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE DICLOFENAC SODIUM DICLOFENAC SODIUM DICLOFENAC SODIUM DICLOFENAC GABAPENTIN GABAPENTIN GABAPENTIN GABAPENTIN PENTOXIFYLLINE PENTOXIFYLLINE PENTOXIFYLLINE PENTOXIFYLLINE Cream Base Cream Base WATER CETOSTEARYL ALCOHOL POLYSORBATE 60 PEG-150 STEARATE STEARETH-20 CYCLOMETHICONE 5 ETHYLHEXYL STEARATE SORBITOL ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE EDETATE DISODIUM METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE"],"spl_unclassified_section":["API LABELS Gabapentin Label Pentoxifyline Label Amantadine label Bupivacaine Label Diclofenac Label Baclogen Label Cyclobenzaprine Label TDC Max Cream Label"],"storage_and_handling":["STORAGE AND HANDLING Prior to compounding, store Alvix- Gapeam Budibac Compounding Ingredients at room temperature between 15 - 30 degrees C (59 - 86 degrees F). For non-sterile use only. Avoid contact with eyes. Keep container tightly closed. Keep out of reach of children. Protect from light. Dispose of product after 30 days of being compounded."],"version":"3"}