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§107.20 婴儿配方粉食用说?Directions for use)

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放大字体缩小字体2011-04-22 04:05:27 来源:GPO 浏览次数9span id="hits">3649
核心提示:除了本章第101部分?05部分中有关的标注要求外,产品标签上还必须附有下列内容:配制和食用指南;在靠近“配制和食用指南”处画上配制婴儿配方粉的主要步骤图示;“在_以前食用”,空格内填上使用期限,用年、月表示;对于浓缩的或者即食的婴儿配方粉,在主要展示版面上加注“加水”或“不加水”说明并加图示;警告式的说明文字放在“配制和食用指南”的下面或附近,以防止对婴儿配方粉的不正确配制和食用;关于家长应该向内科医生请教婴儿配方粉食用的说明。例如:“按医生嘱咐使用”、/div>
发布单位
FDA
FDA
发布文号 50 FR 1840
发布日期 1985-01-14 生效日期 暂无
有效性状?/th> 废止日期 暂无
备注 除了本章?01部分?05部分中有关的标注要求外,产品标签上还必须附有下列内容:配制和食用指南;在靠近“配制和食用指南”处画上配制婴儿配方粉的主要步骤图示;“在_以前食用”,空格内填上使用期限,用年、月表示;对于浓缩的或者即食的婴儿配方粉,在主要展示版面上加注“加水”或“不加水”说明并加图示;警告式的说明文字放在“配制和食用指南”的下面或附近,以防止对婴儿配方粉的不正确配制和食用;关于家长应该向内科医生请教婴儿配方粉食用的说明。例如:“按医生嘱咐使用”、/td>

更多关于婴儿配方粉的法规,请详见美国FDA 21 CFR ?07部分关于婴儿配方粉的法规汇怺/font>、br />
   107.20 Directions for use.

  In addition to the applicable labeling requirements in parts 101 and 105 of this chapter, the product label shall bear:

  (a Under the heading Directions For Preparation and Use directions for:

  ? Storage of infant formula before and after the container has been opened, including a statement indicating that prolonged storage at excessive temperatures should be avoided;

  ? Agitating liquid infant formula before opening the container, such as Shake Well Before Opening:/p>

  ? Sterilization of water, bottle, and nipples when necessary for preparing infant formula for use;

  ? Dilution of infant formula, when appropriate. Directions for powdered infant formula shall contain the weight and volume of powdered formula to be reconstituted.

  (b In close proximity to the Directions for Preparation and Use a pictogram depicting the major steps for preparation of that infant formula, such as (for a concentrated formula(



  (c A Use by ___ date, the blank to be filled in with the month and year selected by the manufacturer, packer, or distributor of the infant formula on the basis of tests or other information showing that the infant formula, until that date, under the conditions of handling, storage, preparation, and use prescribed by label directions, will: ? when consumed, contain not less than the quantity of each nutrient, as set forth on its label; and ? otherwise be of an acceptable quality (e.g., pass through an ordinary bottle nipple?

  (d The statement Add Water or Do Not Add Water as appropriate, to appear on the principal display panel of concentrated or ready-to-feed infant formulas. In close proximity to the statement Add Water a symbol such as



  if the addition of water is necessary. The symbol shall be placed on a white background encircled by a dark border.

  (e A warning statement beneath or in close proximity to the Directions For Preparation and Use that cautions against improper preparation or use of an infant formula, such as THE HEALTH OF YOUR INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND USE、/p>

  (f A statement indicating that parents should consult their physicians about the use of infant formulas, such as USE AS DIRECTED BY A PHYSICIAN、/p>

  [50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002]

地区9/font>美国
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