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The safety of all our customers and their children is Beutlich Pharmaceuticals highest priority. On May 23, 2018 the U.S. Food and Drug Administration released a public safety communication regarding over-the-counter (OTC) products containing benzocaine. This communication called for the immediate removal of benzocaine products which are intended to be used on children under 2 years of age for pain relief due to teething.
Based on the U.S. Food and Drug Administration communication, Beutlich is taking immediate actions to revise all HurriCaine product labeling to make it clear that our HurriCaine products are not to be used on children under the age of 2 years old under any circumstance.
Additionally, although all HurriCaine products currently warn against a rare, but known, condition called methemoglobinemia, which can be associated with the use of benzocaine products, Beutlich intends to revise all HurriCaine product labels to more clearly identify the risks and symptoms presented in accordance with FDA recommendations.
For more information, please visit www.fda.gov or call our Consumer Service hotline at 1-800-238-8542.