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Rulemaking History for OTC Wart Remover Drug Products
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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:

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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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Date created: December 28, 2006; Last updated: May 4, 2007

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