(a) The manufacturer labeling the product for ultimate sale or use selects the type of label and must locate it as follows:

(1) Affixed to the device or its carrying case; and

(2) Affixed to primary panel of the product packaging if the label complying with §211.204-3(a)(1) is not visible at the point of ultimate purchase or the point of distribution to users.

(b) Labeling with a minimum sized label will occur as follows:

(1) If the protector is individually packaged and so displayed at the point of ultimate purchase or distribution to the prospective user, the package must be labeled as follows:

(i) If the primary panel of the package has dimensions greater than 3.8 × 5.0 cm (approximately 11⁄2 × 2 in) the label must be presented on the primary panel.

(ii) If the primary panel of the package is equal to or smaller than 3.8 × 5.0 centimeters, a label at least 3.8 × 5.0 centimeters must be affixed to the package by means of a tag.

(2) If the protector is displayed at the point of ultimate purchase or distribution to prospective users in a permanent or disposable bulk container or dispenser, even if the protector is individually packaged within the dispenser and labeled as above, the container or dispenser itself must be labeled. The label must be readily visible to the ultimate purchaser or prospective user.