349.78—Labeling of eyewash drug products.
(a) Statement of identity.
The labeling of the product identifies the product with one or more of the following terms: “eyewash,” “eye irrigation,” or “eye irrigating solution.”
(b) Indications.
The labeling of the product states, under the heading “Indications,” one of the following phrases:
(1)
“For” (select one of the following: “flushing,” “irrigating,” “cleansing,” “washing,” or “bathing”) “the eye to remove” (select one or more of the following: “loose foreign material,” “air pollutants (smog or pollen),” or “chlorinated water”).
(2)
“For” (select one of the following: “flushing,” “irrigating,” “cleansing,” “washing,” or “bathing”) “the eye to help relieve” (select one or more of the following: “irritation,” “discomfort,” “burning,” “stinging,” “smarting,” or “itching”) “by removing” (select one or more of the following: “loose foreign material,” “air pollutants (smog or pollen),” or “chlorinated water”).
(c) Warnings.
In addition to the warnings in § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for all eyewash products:
(1)
“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.”
(d) Directions.
The labeling of the product contains the following information under the heading “Directions”:
(1) For eyewash products intended for use with an eyecup.
Rinse cup with clean water immediately before each use. Avoid contamination of rim and inside surfaces of cup. Fill cup half full and apply the cup to the affected eye, pressing tightly to prevent the escape of the liquid, and tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash or lotion. Rinse cup with clean water after each use.
(2) For eyewash products intended for use with a nozzle applicator.
Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.