federal_register: 98-4531
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 98-4531 | Ophthalmic Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) ophthalmic drug products. The amendment adds a new warning and revises an existing warning for ophthalmic vasoconstrictor drug products. These products contain the ingredients ephedrine hydrochloride, naphazoline hydrochloride, phenylephrine hydrochloride, or tetrahydrozoline hydrochloride; and they are used to relieve redness of the eye due to minor eye irritations. This proposal is part of the ongoing review of OTC drug products conducted by FDA. | 1998-02-23 | 1998 | 2 | https://www.federalregister.gov/documents/1998/02/23/98-4531/ophthalmic-drug-products-for-over-the-counter-human-use-proposed-amendment-of-final-monograph | https://www.govinfo.gov/content/pkg/FR-1998-02-23/pdf/98-4531.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) ophthalmic drug products. The amendment adds a new warning and revises an existing warning for ophthalmic vasoconstrictor drug products. These... |