医疗器械FDAUDI食品FDA化妆品FDAVCRP注册化妆品CPNP 加拿大化妆品通报ISO13485体系建立medical device purchasing agent, China medical device sourcing, 

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    FDA化妆品标签内容

    • 更新时间0721
    • 文件类型PDF
    • 简要说明美国化妆品标签上重要信息

    详细描述

    What labeling information is required?

    化妆品标签需要什么信息?

    The following information must appear on the principal display panel:

    以下这些信息必须在主要显示面板显示:

    ·         An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].

    一种身份声明,指的是产品的性质和用途,通过通常的名称,一个描述性的名称,一个被公众理解的名字,或者一个插图[21 CFR 701.11]

    ·         An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].

    内容的净数量的精确陈述,以重量、测量、数值计算或数字计数和重量或测量的组合[ 21 CFR 701.13 ]为准。

     

    The following information must appear on an information panel:

    以下这些信息必须在主要信息面板显示:

    ·         Name and place of business. This may be the manufacturer, packer, or distributor. This includes the street address, city, state, and ZIP Code. You may omit the street address if it is listed in a current phone directory or city directory [21 CFR 701.12(a)].

     商业名称和地点。这可能是制造商、包装商或经销商。这包括街道地址、城市、州和邮政编码。如果在当前电话簿或城市目录中列出,您可以省略街道地址[21 CFR 701.12(a)]

    ·         Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by...," or similar wording expressing the facts [21 CFR 701.12(c)].

    经销商声明。如果名称和地址不同于制造商,标签必须注明……制造或类似的措辞表达事实[21 CFR 701.12(c)]

    l  Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.

    材料的事实。没有揭露材料事实是一种误导标签的形式,因此使产品被误导(21 CFR 1.21)。一个例子是安全使用的方向,如果一种产品如果使用不当可能是不安全的。

     

     

     

    ·         Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics.

    警告和警告语句。这些必须突出和突出的。FD&C法案和相关规定指定与特定产品相关的警告和警告声明[21 CFR part 700]。此外,可能对消费者有害的化妆品必须有适当的标签警告[21 CFR 740.1]。这种危险产品的一个例子是易燃化妆品

    l  Ingredients. If the product is sold on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above.

     

    成分:如果产品是在零售基础上销售给消费者,即使是标签为专业使用仅供专业使用的字样,其成分必须出现在信息面板上,以降序排列。(21 CFR 701.3)。记住,如果产品也是一种药物,它的标签必须符合药品和化妆品成分标签的规定,如上所述。

     


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