• Formulating

  lidocaine percentages

  Posted by emily.flemer on November 7, 2017 at 10:46 pm

  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? 

  emily.flemer replied 7 years, 2 months ago 4 Members · 4 Replies
• 4 Replies

• 

  chemicalmatt

  Member

  November 8, 2017 at 3:53 pm

  Federal - see the monograph.

• 

  Bobzchemist

  Member

  November 8, 2017 at 4:50 pm

  Icy Hot sells a 4% lidocaine product OTC. I’ve never seen anything higher without a Rx.

• 

  Chemist5000

  Member

  November 8, 2017 at 11:04 pm

  What are you making?
  Need to look on the FDA website for this…

  Anal Products 2.00-5.00%
  5.00% is the max.

• 

  emily.flemer

  Member

  November 13, 2017 at 8:39 pm

  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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