[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.20]
 
[Page 16]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                          SERVICES (CONTINUED)
 
PART 201--LABELING--Table of Contents
 
                 Subpart A--General Labeling Provisions
 
Sec. 201.20  Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
 
    (a) The label for over-the-counter and prescription drug products
intended for human use administered orally, nasally, rectally, or
vaginally, or for use in the area of the eye, containing FD&C Yellow No.
5 as a color additive using the names FD&C Yellow No. 5 and tartrazine.
The labeling for over-the-counter and prescription drug products shall
bear a statement such as ``Contains FD&C Yellow No. 5 (tartrazine) as a
color additive'' or ``Contains color additives including FD&C Yellow No.
5 (tartrazine)''. The labels of certain drug products subject to this
labeling requirement that are also cosmetics, such as antibacterial
mouthwashes and fluoride toothpastes, need not comply with this
requirement provided they comply with the requirements of Sec. 701.3 of
this chapter.
    (b) For prescription drugs for human use containing FD&C Yellow No.
5 that are administered orally, nasally, vaginally, or rectally, or for
use in the area of the eye, the labeling required by Sec. 201.100(d)
shall bear the warning statement ``This product contains FD&C Yellow No.
5 (tartrazine) which may cause allergic-type reactions (including
bronchial asthma) in certain susceptible persons. Although the overall
incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general
population is low, it is frequently seen in patients who also have
aspirin hypersensitivity.'' This warning statement shall appear in the
``Precautions'' section of the labeling.
    (c) The label for over-the-counter drug products intended for human
use administered orally, nasally, rectally, or vaginally containing FD&C
Yellow No. 6 shall specifically declare the presence of FD&C Yellow No.
6 by listing the color additive using the name FD&C Yellow No. 6. The
labeling for over-the-counter and prescription drug products containing
FD&C Yellow No. 6 shall declare the presence of FD&C Yellow No. 6. The
labels of certain drug products subject to this labeling requirement
that are also cosmetics, such as antibacterial mouthwashes and fluoride
toothpastes, need not comply with this requirement provided they comply
with the requirements of Sec. 701.3 of this chapter.
 
[45 FR 60422, Sept. 12, 1980, as amended at 51 FR 41783, Nov. 19, 1986;
52 FR 21509, June 8, 1987; 59 FR 60898, Nov. 29, 1994]
 
    Effective Date Note: At 53 FR 49138, Dec. 6, 1988, Sec. 201.20(c)
was suspended pending further agency action.