21 CFR 74.1208 - D&C Green No. 8.
(1) The color additive D&C Green No. 8 is principally the trisodium salt of 8-hydroxy-1,3,6-pyrene-trisulfonic acid.
(2) Color additive mixtures for use in externally applied drugs made with D&C Green No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.
(b)Specifications. D&C Green No. 8 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 practices:
(c)Uses and restrictions. D&C Green No. 8 may be safely used in externally applied drugs in amounts not exceeding 0.01 percent by weight of the finished product.