{"abstract":"The Food and Drug Administration (FDA) is issuing a proposed rule to establish conditions under which over-the-counter (OTC) ingrown toenail relief drug products containing sodium sulfide 1 percent in a gel vehicle are generally recognized as safe and effective and not misbranded. This rule also proposes to amend the regulation that lists nonmonograph active ingredients in OTC drug products for ingrown toenail relief by removing sodium sulfide from that list. This proposal is part of FDA's ongoing review of OTC drug products.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2002/10/04/02-25251.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21},{"chapter":null,"citation_url":null,"part":358,"title":21}],"citation":"67 FR 62218","comment_url":null,"comments_close_on":"2002-12-03","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments by December 3, 2002. Please see section IX of this document for the effective date of any final rule that may publish based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. 02N-0359"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2002-10-04","updated_at":"2025-05-12T19:55:46.834-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2002-N-0056-0001","allow_late_comments":false,"id":"FDA-2002-N-0056-0001","comment_end_date":"2002-12-04","regulations_dot_gov_open_for_comment":false},{"comment_count":0,"comment_start_date":"2002-10-04","updated_at":"2025-05-12T19:55:47.180-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2002-N-0056-0002","allow_late_comments":false,"id":"FDA-2002-N-0056-0002","comment_end_date":"2002-12-04","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2002-N-0056","title":"Ingrown Toenail Relief drug products OTC human use"}],"document_number":"02-25251","effective_on":null,"end_page":62221,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2002/10/04/02-25251.xml","html_url":"https://www.federalregister.gov/documents/2002/10/04/02-25251/ingrown-toenail-relief-drug-products-for-over-the-counter-human-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/02-25251?publication_date=2002-10-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2002-10-04/02-25251/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1144,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2002-10-04/pdf/02-25251.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2002-10-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2002/10/04/02-25251.txt","regulation_id_number_info":{"0910-AA01":{"issue":"200310","html_url":"https://www.federalregister.gov/regulations/0910-AA01/over-the-counter-otc-drug-review","title":"Over-the-Counter (OTC) Drug Review","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200310&RIN=0910-AA01&operation=OPERATION_EXPORT_XML","priority_category":"Routine and Frequent"}},"regulation_id_numbers":["0910-AA01"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2002-N-0056","supporting_documents_count":0,"docket_id":"FDA-2002-N-0056","document_id":"FDA-2002-N-0056-0002","regulation_id_number":null,"title":"Ingrown Toenail Relief drug products OTC human use","checked_regulationsdotgov_at":"2025-05-14T02:55:03Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":62218,"subtype":null,"title":"Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use","toc_doc":"Ingrown toenail relief products (OTC)","toc_subject":"Human drugs:","topics":[],"type":"Proposed Rule","volume":67}