(1) The color additive aluminum powder shall be composed of finely divided particles of aluminum prepared from virgin aluminum. It is free from admixture with other substances.
(2) Color additive mixtures for external drug use made with aluminum powder may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b)Specifications. Aluminum powder 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:
Fineness, 100 percent shall pass through a 200-mesh screen and 95 percent shall pass through a 325-mesh screen.
Mercury, not more than 1 part per million.
Arsenic, not more than 3 parts per million.
Lead, not more than 20 parts per million.
Aluminum, not less than 99 percent.
(c)Uses and restrictions. Aluminum powder is safe for use in externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(d)Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 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 certification pursuant to section 721(c) of the act.
[42 FR 38563, July 29, 1977]
Title 21 published on 2014-04-01
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