1. A drug or device shall be deemed to be misbranded unless its label bears:
(a) Adequate directions for use; and
(b) Such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration or administration or application, in such manner and form as are necessary for the protection of users.
2. Where any requirement of paragraph (a) of subsection 1, as applied to any drug or device, is not necessary for the protection of the public health, the Commissioner shall promulgate regulations exempting such drug or device from such requirements.