Heading
(7) Heading means the required statements in quotation marks listed in paragraphs (c)(2) through (c)(9) of this section, excluding subheadings (as defined in paragraph (a)(9) of this section). (8) Inactive ingredient means any component other than an active ingredient. (9) Subheading means the required statements in quotation marks listed in paragraphs (c)(5)(ii) through (c)(5)(vii) of this section. (10) Drug facts labeling means the title, headings, subheadings, and information required under or otherwise described in paragraph (c) of this section. (11) Title means the heading listed at the top of the required OTC drug product labeling, as set forth in paragraph (c)(1) of this section. (12) Total surface area available to bear labeling means all surfaces of the outside container of the retail package or, if there is no such outside container, all surfaces of the immediate container or container wrapper except for the flanges at the tops and bottoms of cans and the shoulders and necks of bottles and jars.