Ingrown toenail relief drug products for over-the-counter human use. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule establishing 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 amends the regulation that lists nonmonograph active ingredients in OTC drug products for ingrown toenail relief by removing sodium sulfide from that list. This final rule is part of FDA's ongoing review of OTC drug products.
D006801:Humans; D009263:Nails, Ingrown / Q000188:drug therapy*; D004366:Nonprescription Drugs / Q000009:adverse effects / Q000145:classification / Q000627:therapeutic use; D011356:Product Labeling / Q000331:legislation & jurisprudence; D013440:Sulfides / Q000009:adverse effects / Q000145:classification* / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
D004366:Nonprescription Drugs; D013440:Sulfides