[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1208]

[Page 401]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                            Subpart B--Drugs
 
Sec. 74.1208  D&C Green No. 8.

    (a) Identity. (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:

Volatile matter (at 135 [deg]C), not more than 15 percent.
Water-insoluble matter, not more than 0.2 percent.
Chlorides and sulfates (calculated as sodium salt), not more than 20 
percent.
The trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 
percent.
The tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 
1 percent.
Pyrene, not more than 0.2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 65 percent.

    (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.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec. 70.25 of this chapter.
    (e) Certification. All batches of D&C Green No. 8 shall be certified 
in accordance with regulations in part 80 of this chapter.