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  7. Rulemaking History for OTC Wart Remover Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Wart Remover Drug Products

Final Monograph (21 CFR part 358 subpart B:)
Miscellaneous External Drug Products for Over-the-Counter Human Use: Wart Remover Drug Products 

OTC Wart Remover Drug Products found on this page:

Wart Remover Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 10/3/1980 45FR65609
    Correction 12/5/1980 45FR80551
Proposed Rule Date FR Citation
Tentative Final Monograph 9/3/1982 47FR39102
    Correction 11/19/1982 47FR52200
Proposed Rule: Revises to be consistent with corn and callus tentative final monograph 3/27/1987 52FR9992
Final Rule Date FR Citation
Final Monograph 8/14/1990 55FR33246
    Correction 9/11/1990 55FR37403
    Technical Amendment: Clarifies that collodoin-like vehicles applied with applicator or
    brush
9/28/1992 57FR44494

Wart Remover Drug Products: Salicylic Acid

Proposed Rule Date FR Citation
Proposed Rule: Revises directions for 15% salicylic acid in karaya gum glycol plaster vehicle 1/28/1994 59FR4015
Final Rule Date FR Citation
Final Rule: Revises directions for 15% salicylic acid in karaya gum glycol plaster vehicle 11/23/1994 59FR60315

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