---
kind: "section"
citation: "21 C.F.R. § 74.1705"
title: "21"
number: "74.1705"
heading: "FD&C Yellow No. 5."
url: "https://uscodex.org/cfr/21/74.1705"
---

# §74.1705. FD&C Yellow No. 5.

- (a) **Identity and specifications.**
  - (1) **The color additive FD&C Yellow No.** 5 shall conform in identity and specifications to the requirements of § [74.705 (a)(1)](/cfr/21/74.705.md?p=a-1) and [(b)](/cfr/21/74.705.md?p=a-b).
  - (2) **FD&C Yellow No.** 5 Aluminum Lake shall be prepared in accordance with the requirements of [§ 82.51](/cfr/21/82.51.md) of this chapter.
  - (3) **Color additive mixtures for drug use made with FD&C Yellow No.** 5 may contain only those diluents that are suitable and are listed in [part 73](/cfr/21/part73.md) of this chapter as safe for use in color additive mixtures for coloring drugs.
- (b) **Uses and restrictions.**
  - (1) **FD&C Yellow No.** 5 may be safely used for coloring drugs generally, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.
  - (2) **FD&C Yellow No.** 5 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, when prepared in accordance with [§ 82.51](/cfr/21/82.51.md) of this chapter.
- (c) **Labeling requirements.**
  - (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of [§ 70.25](/cfr/21/70.25.md) of this chapter.
  - (2) The label of OTC and prescription drug products intended for human use administered orally, nasally, rectally, or vaginally, or for use in the area of the eye, containing FD&C Yellow No. 5 shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive using the names FD&C Yellow No. 5 and tartrazine. The label shall bear a statement such as “Contains FD&C Yellow No. 5 (tartrazine) as a color additive” or “Contains color additives including FD&C Yellow No. 5 (tartrazine).” The labels of certain drug products subject to this labeling requirement that are also cosmetics, such as: antibacterial mouthwashes and fluoride toothpastes, need not comply with this requirement provided they comply with the requirements of [§ 701.3](/cfr/21/701.3.md) of this chapter.
  - (3) **For prescription drugs for human use containing FD&C Yellow No.** 5 that are administered orally, nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by [§ 201.100(d)](/cfr/21/201.100.md?p=d) of this chapter shall, in addition to the label statement required under [paragraph (c)(2)](#c-2) of this section, bear the warning statement “This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions” section of the labeling.
- (d) **Certification.** All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Amendments

[42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979; 50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov. 29, 1994]

### 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 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979; 50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov. 29, 1994]