lidocaine percentages

Has anyone found a regulation regarding lidocaine and how high of a percentage can be used before it crosses over from OTC to prescription?
Is this possibly a state by state regulation? 


  • Federal - see the monograph.
  • Icy Hot sells a 4% lidocaine product OTC. I've never seen anything higher without a Rx.
    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • What are you making?
    Need to look on the FDA website for this...

    Anal Products 2.00-5.00%
    5.00% is the max.
  • Topical for cosmetic procedures.
    Monograph seems to state 5%. What about combining lidocaine with something like menthol to increase the potency? Has anyone found anything stating possible OTC limits on that?
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