{"description":["DESCRIPTION Amitriptyline 2% External Cream Base FOR PHARMACY PRESCRIPTION COMPOUNDING ONLY / Rx ONLY Each Equipto - Amitriptyline External Cream Compounding Kit provides 2.4 grams of Amitriptyline powder for incorporation into 117.6 grams of a Base. The resulting mixture is intended for topical use. CAS-No. : 549-18-8 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride chemical structure"],"effective_time":"20180312","how_supplied":["KIT COMPONENTS Kit Components: 1 color coded teal bottle of 2.4g Amitriptyline, 1 bottle of 117.6g Base, 1 stirring rod, and 1 empty white mixing jar. SIZE 120 grams NDC # 15455-0112-2 Amatriptyline 2.4 grams Base 117.6 grams Avoid contact with eyes. Keep container tightly closed. Keep out of reach of children. Protect from light. Dispose of the product after 30 days of being compounded. * Certificate of analysis on file. The FDA has not approved Equipto - Amitriptyline External Cream Compounding Kit to cure, treat, or mitigate disease. Equipto - Amitriptyline External Cream Compounding Kit is intended for preparation in accordance with state and federal regulation governing compounding and is available to patients by prescription only. Rx ONLY Logo"],"how_supplied_table":["<table> <colgroup> <col width=\"319\"/> <col width=\"319\"/> </colgroup> <tbody> <tr> <td styleCode=\"Lrule Rrule Toprule\">SIZE</td> <td styleCode=\"Lrule Rrule Toprule\">120 grams</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">NDC #</td> <td styleCode=\"Lrule Rrule Toprule\">15455-0112-2</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">Amatriptyline</td> <td styleCode=\"Lrule Rrule Toprule\">2.4 grams</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">Base</td> <td styleCode=\"Lrule Rrule Toprule\">117.6 grams</td> </tr> </tbody> </table>"],"id":"673dbedf-def4-96f6-e053-2a91aa0a8a20","instructions_for_use":["INSTRUCTIONS FOR USE insert page 1 insert page 2"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 15455-0112-2 Equipto - Amitriptyline External Cream Compounding Kit Amitriptyline 2% External Cream in Base FOR PRESCRIPTION COMPOUNDING ONLY RX ONLY Carton Label","TDC MAX Cream - Base 117.6 g NDC# 15455-0999-2 FOR PRESCRIPTION COMPOUNDING ONLY Rx ONLY Base 117.6 g","Amatriptyline USP Powder 2.4 g NDC# 15455-9507-7 FOR PRECSRIPTION COMPOUNDING ONLY Rx ONLY Amitriptyline Label 2.4 g"],"set_id":"a01ec799-8919-4aeb-b463-e2245dfea2af","spl_product_data_elements":["Equipto - Amitriptyline External Cream Compounding Kit Amitriptyline Amitriptyline Amitriptyline AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE TDC Max Cream Cream Base POLYSORBATE 60 PEG-150 STEARATE STEARETH-20 WATER CETOSTEARYL ALCOHOL CYCLOMETHICONE 5 METHYLISOTHIAZOLINONE SORBITOL ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE EDETATE DISODIUM METHYLCHLOROISOTHIAZOLINONE ETHYLHEXYL STEARATE"],"storage_and_handling":["STORAGE AND HANDLING Prior to compounding, store Equipto - Amitriptyline External Cream Compounding Kit at room temperature between 15 - 30 degrees C (59 - 86 degrees F). Protect from light. For external use only."],"version":"6","warnings":["WARNINGS Pictogram Signal word Danger Hazard statement(s) H301 Toxic if swallowed. H361 Suspected of damaging fertility or the unborn child. Precautionary statement(s) P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P281 Use personal protective equipment as required. P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician. P308 + P313 IF exposed or concerned: Get medical advice/ attention. P321 Specific treatment (see supplemental first aid instructions on this label). P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents/ container to an approved waste disposal plant. skull and cross bones health hazard pictogram"]}