{"description":["DESCRIPTION Each Nazirex Compounding Kit provides 3 grams of Levocetirizine Dihydrochloride USP, 3 grams of Loratadine USP, and 54 grams of Base. The resulting mixture is intended for topical use."],"effective_time":"20150714","how_supplied":["TO THE PHARMACIST: Kit Components: 1 color coded light green bottle of 3g of Levocetirizine Dihydrochloride, 1 color coded sand bottle of 3g of Loratadine, and 1 bottle of 54g Base. Equipment needed: mill, spatula, mixing bowl, and Topi-Pump TM . SIZE 60 grams NDC # 15455-9003-9 Levocetirizine Dihydrochloride, USP 3 grams Loratadine, USP 3 grams Base 54 grams Prior to compounding, store Nazirex Compounding Kit at room temperature between 20 - 25 degrees C (68 - 77 degrees F). Protect from light. Nazirex Compounding Kit components have a two-year expiration date. For external 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. * Certificate of analysis on file. The FDA has not approved Nazirex to cure, treat, or mitigate disease. Nazirex is intended for preparation in accordance with state and federal regulation governing compounding and is available to patients by prescription only. Rx ONLY Alvix Laboratories, LLC Ocean Springs, MS 39564 1(888)526-5449 www.Alvix.com logo logo"],"how_supplied_table":["<table> <col width=\"319\"/> <col width=\"319\"/> <tbody> <tr> <td styleCode=\"Lrule Rrule Toprule\">SIZE</td> <td styleCode=\"Lrule Rrule Toprule\">60 grams</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">NDC #</td> <td styleCode=\"Lrule Rrule Toprule\">15455-9003-9</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">Levocetirizine Dihydrochloride, USP</td> <td styleCode=\"Lrule Rrule Toprule\">3 grams</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">Loratadine, USP</td> <td styleCode=\"Lrule Rrule Toprule\">3 grams</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">Base</td> <td styleCode=\"Lrule Rrule Toprule\">54 grams</td> </tr> </tbody> </table>"],"id":"1ae147f6-b554-63d4-e054-00144ff8d46c","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 15455-9003-9 RX ONLY Nazirex Compounding Kit Levocetirizine Dihydrochloride, USP ..... 3 grams Loratadine, USP .................................. 3 grams Cream Base ....................................... 54 grams FOR PRESCRIPTION COMPOUNDING ONLY 60 grams as dispensed Carton"],"set_id":"0d9eca3f-0a35-4783-bd81-c39cc35cf9da","spl_product_data_elements":["Nazirex Compounding Kit Levocetirizine Dihydrochloride and Loratadine Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE Loratadine Loratadine LORATADINE LORATADINE Cream Base Cream Base CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALOE VERA LEAF ALLANTOIN BUTYLPARABEN DIAZOLIDINYL UREA EDETATE DISODIUM ETHYLPARABEN GLYCERETH-20 GLYCERETH-26 GLYCERIN ISOPROPYL MYRISTATE LECITHIN, SOYBEAN MAGNESIUM ALUMINUM SILICATE METHYLPARABEN MINERAL OIL CERESIN PANTHENOL PHENOXYETHANOL POLYSORBATE 20 POLOXAMER 407 POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN SODIUM BENZOATE SORBIC ACID STEARETH-2 TITANIUM DIOXIDE TROLAMINE WATER"],"spl_unclassified_section":["FOR PRESCRIPTION COMPOUNDING ONLY"],"version":"2"}