The agency is also asking companies to stop selling the products and said it will take official action to remove them from stores.
“In addition to our letters to companies who make these products, we urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain,” FDA Commissioner Scott Gottlieb said in a statement Wednesday.
Benzocaine is used in products to treat not just teething, but also sore throats, canker sores, and other oral irritations. It is sold as gels, sprays, ointments, and lozenges. Some of the more common brand names are Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel, and Topex.
The FDA previously warned consumers about the risks of benzocaine, which include a chance of getting a disease known as methemoglobinemia, which can raise the levels of methemoglobin in the blood while dangerously lowering blood oxygen levels. It can be fatal.
Symptoms of methemoglobinemia can happen within minutes of using benzocaine. They include pale, gray- or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; headache; lightheadedness; and a rapid heart rate.