{"data":{"id":"us/21-cfr-349.75","jurisdiction":"us","citation":"21 CFR 349.75","heading":"Labeling of ophthalmic vasoconstrictor drug products.","body":"(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 “redness reliever” or “vasoconstrictor (redness reliever)” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).”\n(b) Indications. The labeling of the product states, under the heading “Indications,” the following phrase: “Relieves redness of the eye due to minor eye irritations.”\n(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 § 349.18:\n(1) “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.”\n(2) “Ask a doctor before use if you have [in bold type] narrow angle glaucoma.”\n(3) “Overuse of this product may produce increased redness of the eye.”\n(4) “If solution changes color or becomes cloudy, do not use.”\n(5) “When using this product [in bold type] pupils may become enlarged temporarily.”\n(d) 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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE","Subpart C—Labeling"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"4ecb119a9ed7fdd9a721816bfe38068cecb4d49d1df7d7e5cbf0a15f7dbe5308","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-349.70","next":"us/21-cfr-349.78"},"notice":"GroundRules: Original legal text. Not legal advice."}