21 CFR 74.1260 - D&C Orange No. 10.
(1) The color additive D&C Orange No. 10 is a mixture consisting principally of 4′,5′-diiodofluorescein, 2′,4′,5′-triiodofluorescein, and 2′,4′,5′,7′-tetraiodofluorescein.
(2) Color additive mixtures for drug use made with D&C Orange No. 10 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.
(b)Specifications. D&C Orange No. 10 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:
(c)Uses and restrictions. D&C Orange No. 10 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice.
(d)Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
Title 21 published on 2015-12-03
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 74 after this date.
Title 21 published on 2015-12-03.
The following are only the Rules published in the Federal Register after the published date of Title 21.
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