(1) The package of an over-the-counter medicine intended for retail sale (but including samples and institutional packages) should contain an alphabetical listing of its inactive ingredients, including colors. The listing should be prefaced by language such as "also contains," "other ingredients" or "inactive ingredients" so as to distinguish clearly between active and inactive ingredients. (2) The listing should be legible and visible to consumers at point of purchase. (3) A small product container (one with a total surface area of less than 12 square inches and which is not contained in an outer container, such as a carton) may list its inactive ingredients in accompanying labeling, such as counter or shelf display. (4) Flavors and fragrances may be listed as "flavors" and "fragrances." (5) Ingredients which may be but are not always present in a product should be identified by words such as "or" or "may also contain." (6) An ingredient whose identity is a trade secret need not be disclosed if the inactive ingredient list states "and other ingredients." For purposes of the Guideline, an ingredient constitutes a trade secret if its presence confers a significant competitive advantage on its manufacturer and the identity of the ingredient cannot be determined using modern analytical technology. (7) The name of an inactive ingredient should be taken from the most current edition of the following reference works: (i) United States Pharmacopeia/Natl. Formulary. (ii) USAN and USP Dictionary of Drug Names. (iii) CTFA (Cosmetic, Toiletry and Fragrance Assn.) Cosmetic Ingredient Dictionary. (iv) Food Chemicals Codex. An ingredient not listed in any of the above reference works should be identified by the name generally recognized by consumers, or if none, the chemical or other technical name. (8) Incidental ingredients which are present in the product at insignificant levels and that have no technical or functional effect need not be identified, unless the omission of the incidental ingredient would constitute a failure to reveal a material fact. Voluntary compliance with these Guidelines should begin when the appropriate product labeling is next reprinted. In any event, all products packaged on or After Dec. 1, 1985, should be in compliance.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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