Code of Federal Regulations Title 21. Food and Drugs § 21.349.70 Labeling of ophthalmic hypertonicity drug products

(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 § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for products containing any ingredient identified in § 349.16:

(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.