Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Topical Antifungal Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Topical Antifungal Drug Products
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Final Monograph**(21 CFR part 333 subpart C)**:***Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Topical Antifungal Drug Products*



OTC Topical Antifungal Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonmonograph Ingredients
	Clotrimazole
	Diaper Rash
	Indications
	Treatment of Tinea Pedis
	Vaginal Drug ProductsTopical Antifungal Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking [PDF]
			3/23/1982
			47FR12480Correction [PDF]
			4/23/1982
			47FR17575Correction [PDF]
			12/7/1982
			47FR54981Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			12/12/1989
			54FR51136Correction
			1/9/1990
			55FR797Correction
			1/22/1990
			55FR2202Final Rule
			Date
			*FR* CitationFinal Rule: Nonmonograph labeling claims
			9/2/1993
			58FR46744Final Monograph
			9/23/1993
			58FR49890

Topical Antifungal Drug Products: Nonmonograph Ingredients

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as non-monograph
			8/25/1992
			57FR38568Correction
			9/8/1992
			57FR40944Technical Amendment: Correct an ingredient name
			10/1/1992
			57FR45295Correction
			11/9/1992
			57FR53300**Final Rule**
			**Date**
			**FR Citation**Final Rule: Classifies category II and III ingredients without data as non-monograph
			5/10/1993
			58FR27636

Topical Antifungal Drug Products: Clotrimazole

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds clotrimazole as GRASE active ingredient
			5/29/2001
			66FR29059Final Rule
			Date
			*FR* CitationFinal Rule
			2/8/2002
			67FR5942

Topical Antifungal Drug Products: Diaper Rash

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			9/7/1982
			47FR39464Extension of Comment Period
			12/28/1982
			47FR57738Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies diaper rash claim as nonmonograph
			6/20/1989
			55FR25240Correction
			7/19/1990
			55FR29453Final Rule
			Date
			*FR* CitationFinal Rule
			12/18/1992
			57FR60430

Topical Antifungal Drug Products: Indications

Proposed Rule
			Date
			*FR* CitationProposed Rule: Revises "cures" to "cures most" and "treats" to "treats most"
			7/22/1999
			64FR39452Final Rule
			Date
			*FR* CitationFinal Rule
			8/29/2000
			65FR52302

Topical Antifungal Drug Products: Treatment of Tinea Pedis

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationNotice: Advisory Committee meeting on effectiveness and labeling
			3/30/2004
			69FR16582Correction
			4/22/2004
			69FR21838Topical Antifungal Drug Products: Vaginal Drug Products

Proposed Rule
			Date
			*FR* CitationReopening of Administrative Record
			11/19/1997
			62FR61710

                                                                                  Content current as of:
      06/12/2018Historical Status of OTC Rulemakings
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop