(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a ``hypertonicity'' (select one of the following: ``eye'' or ``ophthalmic'') ``(insert dosage form, e.g., drops).''
(b) Indications. The labeling of the product states, under the heading ``Indications,'' the following phrase: ``For the temporary relief of corneal edema.''
(c) Warnings. In addition to the warnings in Sec. 349.50, the labeling of the product contains the following warnings under the heading ``Warnings'' for products containing any ingredient identified in Sec. 349.16:
(1) ``Do not use this product except under the advice and supervision of a doctor. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor.''
(2) ``This product may cause temporary burning and irritation on being instilled into the eye.''
(3) ``If solution changes color or becomes cloudy, do not use.''
(d) Directions. The labeling of the product contains the following information under the heading ``Directions'': Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a doctor.