---
kind: "section"
citation: "21 C.F.R. § 74.1254"
title: "21"
number: "74.1254"
heading: "D&C Orange No. 4."
url: "https://uscodex.org/cfr/21/74.1254"
---

# §74.1254. D&C Orange No. 4.

- (a) **Identity.**
  - (1) the color additive D&C Orange No. 4 is principally the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic acid.
  - (2) **Color additive mixtures for use in externally applied drugs made with D&C Orange No.** 4 may contain only those diluents that are suitable and that are listed in [part 73](/cfr/21/part73.md) of this chapter for use in color additive mixtures for coloring externally applied drugs.
- (b) **Specifications.** D&C Orange No. 4 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. 4 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice.
- (d) **Labeling.** 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](/cfr/21/70.25.md) of this chapter.
- (e) **Certification.** All batches of D&C Orange No. 4 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Amendments

[42 FR 52396, Sept. 30, 1977, as amended at 43 FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, 1981]

### Authority

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

### Source

Source: 42 FR 15654, Mar. 22, 1977, unless otherwise noted.

### Amendments

[42 FR 52396, Sept. 30, 1977, as amended at 43 FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, 1981]