Identity. The color additive D&C Green No. 6 is 1,4-bis[(4-methylphenyl)amino]-9,10-anthracenedione (CAS. Reg. No. 128-80-3).
Specifications. The color additive D&C Green No. 6 for use in coloring externally applied drugs shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:
Uses and restrictions. The color additive D&C Green No. 6 may be safely used for coloring externally applied drugs in amounts consistent with current good manufacturing practice.
Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.
Certification. All batches of D&C Green No. 6 shall be certified in accordance with regulations promulgated under part 80 of this chapter.
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