(a) The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of § 74.1255(a)(1) and (b) of this chapter. D&C Orange No. 5 is restricted to the uses described in this section.

(b) The color additive D&C Orange No. 5. may be safely used for coloring externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug. The color additive D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be applied to the lips in amounts not exceeding 5.0 percent by weight of the finished cosmetic products, and for coloring mouthwashes, dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice.