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| column | value |
|---|---|
| 類別 | 藥政管理類,成藥及固有成方製劑管理辦法 |
| 法規性質 | 法規命令 |
| 法規名稱 | 〈成藥及固有成方製劑管理辦法〉附件二 |
| 條文內容 | <p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 18pt;">成藥及固有成方製劑管理辦法第二條附件二修正規定</span></b> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="727"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 545.4pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">劑別</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">主要成分</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">主要效能</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="text-fit: 139.5pt;"><b><span style="letter-spacing: 15.25pt; font-family: 標楷體;">其他規定</span></b></span><b> </b></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">一</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">清涼劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乙醚</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Ether)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯丁醇</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Chlorobutanol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蜂蜜</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Mel)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">葉綠素</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Chlorophyll)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿仙草</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">砂仁</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Amomum Xanthioides)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">豆蔻</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Elettaria Cardamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘草</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">小茴香</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Foenlculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人參</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">木香</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Inula Helenium)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">丁香</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Caryophyllus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Cinnamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">樟腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Camphor)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">龍腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Borneal)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">芍藥</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Paeonia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">山椒</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Xanthoxylum Piperitum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">生薑</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Zingiber)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">胃痛、嘔吐、口臭、清涼、中暑、吐瀉、暈車、暈船、腹痛。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">二</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">外用軟油膏類</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">樟腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Camphor)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">多綠油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Methyl Salicylate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">丁香油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Eugenol)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">切傷、刀傷、創傷、火傷、蟲咬傷、頭暈。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">三</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">外用撒布劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Oleum Cassiae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白陶土</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Kaolin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鋅</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Zinc Carbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鎂</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Magnesium Carbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">滑石粉</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Talc)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澱粉</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Starch)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Boric Acid)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">防止體臭、止癢、吸著、收歛。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">四</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">養毛髮劑</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">脫毛之防止、育毛為目的之外用劑，劑型原則上液劑為準</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">雷鎖辛</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Resorcinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">醇</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Alcohol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Glycerin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蓖麻油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Castor Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">石炭酸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Phenol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">抗組織胺</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Antihistamine)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">育毛、薄毛、圓形脫毛症、止癢、預防脫毛、促進發毛、養毛、脂漏治療（皮脂漏）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">五</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">含藥酒類</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（六）漱口水劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; color: #111111; font-size: 12pt;">氯己定葡糖酸鹽氯己定葡糖酸鹽</span><span style="font-family: 新細明體; font-size: 12pt;">（</span><span style="font-family: times new roman,serif; font-size: 12pt;">Chlorhexidine Gluconate</span><span style="font-family: 新細明體; font-size: 12pt;">） </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">十六烷基氯化砒啶</span><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">（</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium Chloride</span><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">口腔內之殺菌、消毒、清潔、去除口臭。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">1.</span><span style="font-family: 標楷體; font-size: 12pt;">適用範圍：凡以口腔內之清潔殺菌等為目的，且成分含量符合本基準範圍而製成之漱口水劑均適用本基準。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2.</span><span style="font-family: 標楷體; font-size: 12pt;">有效成分之種類含量及配合規則： </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 12pt;">（1）<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 12pt;">有效成分之種類含量： </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="328"> <tbody> <tr style="page-break-inside: avoid; height: 24.05pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 24.05pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center;"><span style="font-family: 標楷體;">有 效 成 分 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 24.05pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體;">含量範圍 (% w/v)</span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.55pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 26.55pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: 標楷體; color: #111111;">氯己定葡糖酸鹽氯己定葡糖酸鹽 </span></p> <p><span style="font-family: 新細明體,serif;">（</span>Chlorhexidine Gluconate<span style="font-family: 新細明體,serif;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 26.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">0.1 <span style="font-family: 新細明體,serif;">＜</span> <span style="font-family: 新細明體,serif;">≦</span> 0.2</p> </td> </tr> <tr style="page-break-inside: avoid; height: 27.8pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 27.8pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: 標楷體; color: #000000;">十六烷基氯化砒啶</span><span style="font-family: 標楷體; color: #000000;">（</span>Cetylpyridinium Chloride<span style="font-family: 標楷體; color: #000000;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 27.8pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">0.045 <span style="font-family: 新細明體,serif;">≦</span> <span style="font-family: 新細明體,serif;">≦</span> 0.1</p> </td> </tr> </tbody> </table> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 12pt;">（2）<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 12pt;">配合規則：限單方製劑。 </span></p> <ol> <li><span style="font-family: 標楷體; font-size: 12pt;">劑型：外用液劑。 </span></li> <li><span style="font-family: 標楷體; font-size: 12pt;">適應症：口腔內之殺菌、消毒、清潔、去除口臭。</span> </li> <li><span style="font-family: 標楷體; font-size: 12pt;">用法及用量：每次以適量之漱口水劑於口腔內漱洗並停留三十秒至六十秒後吐出，可於早晚或需要時使用。本類製劑須刊載具體使用方法及用量。</span> </li> <li><span style="font-family: 標楷體; font-size: 12pt;">注意事項：</span> </li> </ol> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（1） </span><span style="font-family: 標楷體; font-size: 12pt;">為防止兒童誤食請妥善保管。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（2） </span><span style="font-family: 標楷體; font-size: 12pt;">避免陽光直射，宜保存於陰涼之處。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（3） </span><span style="font-family: 標楷體; font-size: 12pt;">未滿六歲兒童不得使用，</span> <span style="font-family: 標楷體; font-size: 12pt;">六歲以上十二歲以下兒童需在大人指導下使用。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（4） </span><span style="font-family: 標楷體; font-size: 12pt;">僅供漱洗，請勿吞服。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（5） </span><span style="font-family: 標楷體; font-size: 12pt;">本產品在正常使用下是安全的，但如有副作用的情形發生時（如灼熱感及刺痛感等），請立即停用。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（6） </span><span style="font-family: 標楷體; font-size: 12pt;">含酒精之本類製劑，增列下述注意事項：本品含酒精</span><span style="font-family: times new roman,serif; font-size: 12pt;">○○%</span><span style="font-family: 標楷體; font-size: 12pt;">，宜審慎使用。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（7） </span><span style="font-family: 標楷體; font-size: 12pt;">口腔潰瘍者，請勿使用含酒精成分之本類製劑。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（8） </span><span style="font-family: 標楷體; font-size: 12pt;">如不慎過量使用及吞服後，感覺不適者，請立即就醫。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（9） </span><span style="font-family: 標楷體; font-size: 12pt;">使用後三十分鐘內請勿進食、吸煙或服用飲料。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體;"><span style="font-size: 18px;">（10）</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 12pt;">含</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium chloride</span><span style="font-family: 標楷體; font-size: 12pt;">之本類製劑，增列下述注意事項：過度使用含</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium chloride</span><span style="font-family: 標楷體; font-size: 12pt;">漱口水劑可能使牙齒染色。</span> </p> </td> </tr> </tbody> </table> <p><span style="font-family: 標楷體;">備註：其他成份視其藥品安全性之程度由衛生署審定加減。</span> </p> </td> </tr> </tbody></table> |
| 發佈日期 | 2013-12-03 |
| 附件檔案 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4490&type=0 |