§ 349.65 Labeling of ophthalmic emollient drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a “lubricant” or “emollient (lubricant)” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., ointment).” (b) Indications. The labeling of the product states, under the heading “Indications,” one or more of the following phrases: (1) “For the temporary relief of burning and irritation due to dryness of the eye.” (2) “For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.” (3) “For use as a protectant against further irritation or to relieve dryness of the eye.” (4) “For use as a lubricant to prevent further irritation or to relieve dryness of the eye.” (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 § 349.14: “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.” (d) Directions. The labeling of the product contains the following information under the heading “Directions”: Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.