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Current as of January 02, 2025 | Updated by Findlaw Staff
(a) Identity. The color additive 2–[[2,5–diethoxy–4–[ (4–methylphenyl)thio]phenyl]azo]–1,3,5–benzenetriol is formed in situ in soft (hydrophilic) contact lenses.
(b) Uses and restrictions. The color additive 2–[[2,5–diethoxy–4–[ (4–methylphenyl)thio]phenyl]azo]–1,3,5–benzenetriol may be safely used to mark soft (hydrophilic) contact lenses with the letter R or the letter L for identification purposes subject to the following restrictions:
(1) The quantity of the color additive does not exceed 1.1x10−7 grams in a soft (hydrophilic) contact lens.
(2) When used as specified in the labeling, there is no measurable migration of the color additive from the contact lens to the surrounding ocular tissue.
(3) Authorization for this use shall not be construed as waiving any of the requirements of section 510(k) and 515 of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.73.3115 2–[[2,5–Diethoxy–4–[ (4–methylphenyl) thiol]phenyl]azo]–1,3,5–benzenetriol - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-73-3115/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
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