The principal display panel is that portion of the label which is intended
to be displayed, presented, shown, or examined under customary conditions
for retail sales. The area of the principal display panel is considered to
be:
In the case of a rectangular package, the height x width of one side;
In the case of a cylindrical or nearly cylindrical package, 40% of height
x circumference; or
In the case of any other shapes, 40% of the total surface area of the
container, unless a more prominent site exists.
The statement of identity of the device must be listed on
the principal display panel.
It must list the common name of the device followed by a statement
of its principal intended action(s);
Indications for use must be listed in the directions for use;
and
The statement must be in bold type, reasonably related in size
to the most prominent printed matter on the display panel, and
must be in lines generally parallel to the base of the package
on which it rests.
The label of an over-the-counter (OTC) device in package form
must contain a statement of net quantity of contents in terms
of weight, measure, numerical count; or a combination of numerical
count and weight, measure, or size, which are described below:
Count - If the declaration by count does not give accurate information
as to the quantity, it shall be augmented by statements of weight,
measure, or size;
Measure - In cases of established customer usage and trade custom
where units of linear measure or measure of area are used, they
shall be augmented when necessary with statements of weight measure
or size. Liquid measure is to be expressed in terms of the U.S.
gallon of 231 cu. In. And quart, ping, and fluid ounce subdivisions,
and shall express the volume at 68 degrees Fahrenheit; and
Weight - Terms of weight are to be expressed in avoirdupois
pound and ounce. Units of metric weight or measure are considered
supplemental. The declaration may contain common or decimal fractions.
Common fractions shall be reduced to their lowest terms.
Placement - The declaration shall appear as a separate
item on each principal display panel; and be separated by at least a
space equal to the height of the lettering used in the declaration,
from other information appearing above and below, and separated by at
least twice the width of the letter "N" from labeling to the
left or right.