§201.130. Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU). — Inbound Citations

(1) A nonprescription drug product with an ACNU must comply with applicable labeling requirements for nonprescription drug products under this part, including the format and content requirements for nonprescription drug product labeling under § 201.66 and the statements specified in § 201.130(a) and (b).

(1) A nonprescription drug product with an ACNU must comply with applicable labeling requirements for nonprescription drug products under this part, including the format and content requirements for nonprescription drug product labeling under § 201.66 and the statements specified in § 201.130(a) and (b).

(d) The statement about the ACNU specified in § 201.130(b)(1) must meet all format requirements as follows:

(1) The statement about the ACNU must appear on the principal display panel (see § 201.60) and the immediate container surface that the consumer is most likely to view when seeking information about the drug product. If the immediate container is a bottle, the statement about the ACNU must appear on the surface that the consumer is most likely to consider the front of the bottle. If the immediate container is a blister card (including a card that contains more than one blister unit), the statement about the ACNU must appear on the blister card surface that the consumer would most likely view when removing the drug product from the blister card. If the blister card contains more than one blister unit (e.g., perforated blister card where individual blister units can be separated from one another), the statement about the ACNU does not need to be included on each blister unit of a blister card. However, the statement about the ACNU must remain intact and be readable on the blister card when the drug product is removed from each blister unit.

(2) The statement about the ACNU must appear in boldface and black type.

(3) The statement about the ACNU must appear in a yellow background banner. No other information or statements may be included within the yellow background banner.

(4) The statement about the ACNU must be in one of the following font sizes, whichever is greater:

(i) At least 25 percent as large as the font size of the largest printed words on the principal display panel and immediate container; or

(ii) At least 12-point font (1 point = 0.0138 inches).

(5) An applicant may request an exception to the minimum font size requirement specified in paragraph (d)(4) of this section for containers where its size would render compliance with this requirement impractical. FDA may allow such an exception upon request by an applicant if FDA determines an exception is warranted.

(1) It does not comply with the labeling requirements specified in paragraphs (c) and (d) of this section and § 201.130(a) through (c); or