{"effective_time":"20160721","id":"c107b5b2-6eba-429b-a8de-d713b791d3fe","instructions_for_use":["Instructions for Preparation Page 1 Page 2 NDC 70332-101-01 For Prescription Compounding Only Rx only RapidPaq™ Ketophene™ (20% Ketoprofen topical cream kit) RapidPaq™ kits provide a convenient approach to rapidly prepare prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practices (cGMP). Description: This kit contains active and inactive materials to prepare approximately 167 grams of ketoprofen topical cream. This kit may only be used for prescription compounding by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient. Active Ingredients: - 33.5 g Ketoprofen, USP Inactive Ingredients: - 100 g RapidPaq Cream Base (D.I Water, Cetearyl Alcohol, Cyclomethicone, Polysorbate-60, Sorbitol, Phenoxyethanol(and)ethylhexlglycerin, Tocopheryl Acetate, Aloe Barbadensis, Disodium EDTA,) - 33.5 g ethoxy diglycol - Spatula -Instructions Pharmacist instructions for Preparation 1 Remove and Inspect the Contents of the Kit Ensure that all components are present. Ensure that the safety seals are present on the Ketoprofen, ethoxy diglycol and RapidPaq Cream Base. If components are missing or not intact, do not use the kit. 2 Prepare for Mixing Wear gloves and eye protection during mixing operations. Remove cap and seal from the RapidPaq Cream Base. Break the seal and remove the cap from the Ketoprofen and ethoxy diglycol. 3 Dissole the Ketoprofen Transfer approximately 2/3 of the ethoxy diglycol to the Ketoprofen jar. With the supplied spatula, mix them together until they are mostly dissolved. Transfer the Ketoprofen mix to the jar of RapidPaq Cream Base. Transfer the remaining 1/3 of ethoxy diglycol to the Ketoprofen jar and repeat the mixing process. transfer the remaining Ketoprofen mix to the jar of RapidPaq Cream Base. 4 Complete the Mixing Process Using the spatula, mix the RapidPaq Crean base jar that now contains the ethoxy diglycol and Ketoprofrn ingredients thoroughly for about 2 minutes or until fully dissolved. 5 Relabel the Resulting Cream Label the resulting topical cream as required for prescription products. Ensure that the original RapidPaq Cream Base label is removed or obscured, since the original label is no longer accurate once the cream is prepared. Discard the spatula. Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the topical cream between 15-30°C (59-86°F). The resulting final topical cream is stable for up to eight weeks. U.S. Patents Pending Repacked and Distributed by: California Pharmaceuticals, LLC 768 Calle Plano Camarillo, CA 93012 CS113-A1 rev 2 California PHARMACEUTICALS LLC Ketophehe Kit Instructions 1 Ketophehe Kit Instructions 2"],"openfda":{},"package_label_principal_display_panel":["RapidPaq™ Cream Base product label Do not use if seal is broken California PHARMACEUTICALS LLC RapidPaq™ Cream Base Net contents: 100g Ingredients: (D.I Water, Cetearyl Alcohol, Cyclomethicone, Polysorbate-60, Sorbitol, Phenoxyethanol(and)ethylhexlglycerin, Tocopheryl Acetate, Aloe Barbadensis, Disodium EDTA RX Only Manufactured For California Pharmaceuticals, LLC, Camarillo, CA 93012 RapidPaq Label","Ethoxy Diglycol product label Do not use if safety seal is broken Ethoxy Diglycol Diethyl Glycol Monoethly Ether CAS # 111-90-0 Net contents 33.5 g Rx Only Repackaged By; California Pharmaceuticals, LLC Camarillo, Ca 93012 California PHARMACEUTICALS LLC cs112-A1 rev 1 Ethoxy Diglycol Label","Ketoprofen, USP product label Do not use if seal is broken Ketoprofen, USP C16H14O3 CAS # 22071-15-4 Net contents: 33.5 g California PHARMACEUTICALS RX Only Repackaged by California Pharmaceuticals, LLC, Camarillo, CA 93012 CS110-A1 rev 1 Ketoprofen USP Label","Ketophene Kit product label NDC 70332-101-01 Rx only RapidPaq™ Kit for Topical Cream KETOPHENE™ (20% ketoprofen cream kit) Non-Steroid Anti-Inflammatory Store kit at room temperature, 15-30°C (59-86°F0 Description: This kit contains active and inactive materials to prepare approximately 167 grams of Ketoprofen topical cream. This kit may only be used for prescription compounding by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient. Active Ingredients: - 33.5 g Ketoprofen, USP Inactive Ingredients: - 100 g RapidPaq Cream Base (D.l Water, Cetearyl Alcohol, Cyclomethicone, Polysorbate-60, Sorbitol, Phenoxyethanol (and) ethylhexylglycerin, Tocopheryl Acetate, Aloe Barbadensis, Disodium EDTA) - 33.5g ethoxy diglycol - Spatula - Instrustions U. S. Patents Pending Do not use if safety seal is broken California PHARMACEUTICALS Repacked and Distributed By: California Pharmaceuticals, LLC 768 Calle Plano Camarillo, CA 93012 CS114-A1 rev 2 Ketophene Kit"],"set_id":"271e6176-698a-30dd-e054-00144ff88e88","spl_product_data_elements":["KETOPHENE KETOPHENE ETHOXYDIGLYCOL DIETHYLENE GLYCOL MONOETHYL ETHER DIETHYLENE GLYCOL MONOETHYL ETHER KETOPROFEN KETOPROFEN KETOPROFEN KETOPROFEN RapidPaq Cream Base RapidPaq Cream Base WATER CETOSTEARYL ALCOHOL CYCLOMETHICONE POLYSORBATE 60 SORBITOL PHENOXYETHANOL ETHYLHEXYLGLYCERIN .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF EDETATE SODIUM"],"version":"4"}