---
kind: "section"
citation: "21 C.F.R. § 74.3708"
title: "21"
number: "74.3708"
heading: "D&C Yellow No. 8."
url: "https://uscodex.org/cfr/21/74.3708"
---

# §74.3708. D&C Yellow No. 8.

- (a) **Identity and specifications.** The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § [74.1708(a)(1)](/cfr/21/74.1708.md?p=a-1) and [(b)](/cfr/21/74.1708.md?p=a-b).
- (b) **Uses and restrictions.**
  - (1) **D&C Yellow No.** 8 may be safely used for coloring contact lens solution for coloring disposable daily-wear hydrogel-based soft (hydrophilic) contact lenses at a level not to exceed 0.044 percent in the contact lens solution. Following excitation by ultraviolet light, the colored contact lenses fluoresce a yellow-green color. The contact lens solution colored with D&C Yellow No. 8 is distributed by prescription only and used in accordance with the supplied directions for use. Contact lens solutions containing D&C Yellow No. 8 are intended for use only for coloring contact lenses that are worn for infrequent, celebratory occasions, and not for regular or daily use.
  - (2) Authorization for this use shall not be construed as waiving any of the requirements of sections [510(k)](/cfr/21/510.md?p=k), [515](/cfr/21/515.md), and [520(g)](/cfr/21/520.md?p=g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens solution in which the color additive is used.
- (c) **Labeling.** The label of the color additive shall conform to the requirements of [§ 70.25](/cfr/21/70.25.md) of this chapter.
- (d) **Certification.** All batches of D&C Yellow No. 8 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Amendments

[83 FR 48375, Sept. 25, 2018]

### 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

[83 FR 48375, Sept. 25, 2018]