What is the maximum concentration of topical lidocaine that can be compounded in California?

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Last updated: February 14, 2025View editorial policy

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From the FDA Drug Label

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton TopCare® health COMPARE TO ICY HOT® ACTIVE INGREDIENTS* MAXIMUM STRENGTH LIDOCAINE Cold & Hot Pain Relieving Lidocaine Cream 4% Lidocaine • 1% Menthol LIDOCAINE 4% / TOPICAL ANALGESIC MENTHOL 1% / TOPICAL ANALGESIC Helps to Numb Away Pain Non-Greasy Maximum Strength External Analgesic with 4% Lidocaine NET WT 2.7 OZ (77 g)

The maximum concentration of topical lidocaine mentioned in the label is 4%. However, this does not necessarily indicate the maximum concentration that can be compounded in California.

  • The label does not provide information on compounding regulations or maximum allowable concentrations for topical lidocaine in California.
  • Therefore, based on the provided label, no conclusion can be drawn about the maximum concentration of topical lidocaine that can be compounded in California 1.

From the Research

Maximum Concentration of Topical Lidocaine

  • The maximum concentration of topical lidocaine that can be compounded is not explicitly stated in the provided studies as being specific to California.
  • However, study 2 mentions the use of a 30% lidocaine gel compound, which suggests that high concentrations of lidocaine can be used topically.
  • Study 3 states that lidocaine is effective at concentrations between 5% and 20% when used as a single agent.
  • Study 4 evaluates the permeability of 2.5 and 5% lidocaine hydrochloride in human skin using iontophoresis technique, but does not provide information on the maximum concentration that can be compounded.

Relevant Concentrations

  • Study 5 compares the absorption of five commonly-available lidocaine preparations, including a 4% lidocaine preparation and a preparation containing 6% lidocaine.
  • Study 6 discusses the use of lidocaine in skin surgery, but does not provide information on the maximum concentration of topical lidocaine that can be compounded.
  • It is worth noting that the concentration of lidocaine that can be safely used topically may depend on various factors, including the individual patient and the specific application site 2.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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