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U.S. Department of Health and Human Services

Drugs

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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 [PDF] 10/3/1980 45FR65609
    Correction [PDF] 12/5/1980 45FR80551
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 9/3/1982 47FR39102
    Correction [PDF] 11/19/1982 47FR52200
Proposed Rule: Revises to be consistent with corn and callus tentative final monograph [PDF] 3/27/1987 52FR9992
Final Rule Date FR Citation
Final Monograph [PDF] 8/14/1990 55FR33246
    Correction [PDF] 9/11/1990 55FR37403
    Technical Amendment: Clarifies that collodoin-like vehicles applied with applicator or brush [PDF] 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 [PDF] 1/28/1994 59FR4015
Final Rule Date FR Citation
Final Rule: Revises directions for 15% salicylic acid in karaya gum glycol plaster vehicle [PDF] 11/23/1994 59FR60315
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