§349.55. Labeling of ophthalmic astringent drug products.
21 C.F.R. § 349.55
Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “astringent” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).”
Indications. The labeling of the product states, under the heading “Indications,” the following phrase: “For the temporary relief of discomfort from minor eye irritations.”
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 § 349.10:
“If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.”
“If solution changes color or becomes cloudy, do not use.”
Directions. The labeling of the product contains the following information under the heading “Directions”: Instill 1 to 2 drops in the affected eye(s) up to four times daily.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source
Source: 53 FR 7090, Mar. 4, 1988, unless otherwise noted.