21 CFR 74.1261 - D&C Orange No. 11.
(a) Identity. (1) The color additive D&C Orange No. 11 is a mixture consisting principally of the disodium salts 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. 11 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. The color additive D&C Orange No. 11 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:
(c) Uses and restrictions. D&C Orange No. 11 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.
(e) Certification. All batches of D&C Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter.