Drugs

Rulemaking History for OTC Topical Antifungal Drug Products

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:

 


Topical Antifungal Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]3/23/198247FR12480disclaimer icon
    Correction [PDF]4/23/198247FR17575disclaimer icon
    Correction [PDF]12/7/198247FR54981disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]12/12/198954FR51136disclaimer icon
    Correction [PDF]1/9/199055FR797disclaimer icon
    Correction [PDF]1/22/199055FR2202disclaimer icon
Final RuleDateFR Citation
Final Rule: Nonmonograph labeling claims [PDF]

9/2/1993

58FR46744disclaimer icon
Final Monograph [PDF]9/23/199358FR49890disclaimer icon

Topical Antifungal Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as non-monograph [PDF]8/25/199257FR38568disclaimer icon
    Correction [PDF]9/8/199257FR40944disclaimer icon
    Technical Amendment: Correct an ingredient name [PDF]10/1/199257FR45295disclaimer icon
    Correction [PDF]11/9/199257FR53300disclaimer icon
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as non-monograph [PDF]5/10/199358FR27636disclaimer icon

Topical Antifungal Drug Products: Clotrimazole
Proposed RuleDateFR Citation
Proposed Rule: Adds clotrimazole as GRASE active ingredient [PDF]5/29/200166FR29059disclaimer icon
Final RuleDateFR Citation
Final Rule [PDF]2/8/200267FR5942disclaimer icon

Topical Antifungal Drug Products: Diaper Rash
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/7/198247FR39464disclaimer icon
Extension of Comment Period [PDF]12/28/198247FR57738disclaimer icon
Proposed RuleDateFR Citation
Proposed Rule: Classifies diaper rash claim as nonmonograph [PDF]6/20/198955FR25240disclaimer icon
Correction [PDF]7/19/199055FR29453disclaimer icon
Final RuleDateFR Citation
Final Rule [PDF]12/18/199257FR60430disclaimer icon

Topical Antifungal Drug Products: Indications
Proposed RuleDateFR Citation
Proposed Rule: Revises "cures" to "cures most" and "treats" to "treats most" [PDF]7/22/199964FR39452disclaimer icon
Final RuleDateFR Citation
Final Rule [PDF]8/29/200065FR52302disclaimer icon

Topical Antifungal Drug Products: Treatment of Tinea Pedis
Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Advisory Committee meeting on effectiveness and labeling [PDF]3/30/200469FR16582disclaimer icon
Correction [PDF]4/22/200469FR21838disclaimer icon

Topical Antifungal Drug Products: Vaginal Drug Products
Proposed RuleDateFR Citation
Reopening of Administrative Record [PDF]11/19/199762FR61710disclaimer icon

 

Page Last Updated: 06/12/2017
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