(1) The color additive zinc oxide is a white or yellow-white amorphous powder manufactured by the French process (described as the indirect process whereby zinc metal isolated from the zinc-containing ore is vaporized and then oxidized). It is principally composed of Zn.
(2) Color additive mixtures for drug use made with zinc oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b)Specifications. Zinc oxide 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:
Zinc oxide (as ZnO), not less than 99 percent.
Loss on ignition at 800 °C, not more than 1 percent.
Cadmium (as Cd), not more than 15 parts per million.
Mercury (as Hg), not more than 1 part per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.
(c)Uses and restrictions. The color additive zinc oxide may be safely used for coloring externally applied drugs, including those used in the area of the eye, in amounts consistent with good manufacturing practice.
(d)Labeling. The color additive and any mixtues prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of § 70.25 of this chapter.
(e)Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from the certifiation pursuant to section 721(c) of the act.
[42 FR 37537, July 22, 1977]
Title 21 published on 2014-04-01
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