[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR82.1255]
[Page 443]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 82 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS--
Subpart C Drugs and Cosmetics
Sec. 82.1255 D&C Orange No. 5.
(a) The color additive D&C Orange No. 5 shall conform in identity
and specifications to the requirements of Sec. 74.1255(a)(1) and (b) of
this chapter. D&C Orange No. 5 is restricted to the uses described in
this section.
(b) The color additive D&C Orange No. 5. may be safely used for
coloring externally applied drugs in amounts not exceeding 5 milligrams
per daily dose of the drug. The color additive D&C Orange No. 5 may be
safely used for coloring lipsticks and other cosmetics intended to be
applied to the lips in amounts not exceeding 5.0 percent by weight of
the finished cosmetic products, and for coloring mouthwashes,
dentifrices, and externally applied cosmetics in amounts consistent with
current good manufacturing practice.
[49 FR 13343, Apr. 4, 1984]
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