As used in this part 12: (1) "Over-the-counter drug" means a drug that is a personal care product that contains a label that identifies the product as a drug, as required by and meeting the labeling requirements of 21 CFR 201.66. (2) (a) "Personal care product" means: (I) Any article intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance of a person; and (II) Any item intended to be used as a component of an article listed in subparagraph (I) of this paragraph (a). (b) "Personal care product" does not include prescription drugs. (3) "Plastic" means a synthetic material made by linking monomers through a chemical reaction to create an organic polymer chain that can be molded or extruded at high heat into various solid forms that retain their defined shapes during the life cycle and after disposal. (4) "Synthetic plastic microbead" means an intentionally added, nonbiodegradable, solid plastic particle measuring less than five millimeters in size intended to aid in exfoliating or cleansing as part of a rinse-off product.
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