On April 7, 2011, the U.S. Food and Drug Administration (FDA) warned the public about the use of over-the-counter (OTC) products containing benzocaine, an ingredient used to reduce pain in the mouth and gums. Benzocaine use may cause a rare, but serious condition where the amount of oxygen that can be carried through the blood stream is greatly reduced. This condition is called methemoglobinemia. FDA is particularly concerned about the use of OTC benzocaine products in children for relief of pain from teething because of the serious outcomes, including death, that may be associated with methemoglobinemia, as well as the difficulty parents or consumers may have in recognizing the signs and symptoms of methemoglobinemia when using these products at home. Furthermore, symptoms of methemoglobinemia may not always be evident or attributed to the condition.
Parents and caregivers should not use OTC benzocaine products on children under two years of age, except under the advice and supervision of a healthcare professional. If benzocaine products are used, it should be used sparingly and only when needed, but not more than four times a day.