[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR82.1255]

[Page 446]
 
                        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--Table of Contents
 
                     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]