Safety Information on Benzocaine-Containing Products

Benzocaine is in many oral drug products currently used to relieve pain in the mouth and gums from a variety of conditions, or for numbing the throat or airway for medical procedures. Benzocaine oral drug products come in the form of gels, sprays, liquids, and lozenges. Benzocaine sprays are not FDA-approved to numb the mucous membranes of the mouth and throat, or to suppress the gag reflex during minor medical and surgical procedures.

Additionally, benzocaine is an active ingredient in non-oral over-the-counter (OTC) drug products, as well as prescription drug products used to treat other conditions, such as numbing pain on skin.

Benzocaine can cause a serious condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, is life-threatening and can result in death. Therefore, the FDA is warning that OTC oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug facts label. These products carry serious risks and provide little to no benefit for the treatment of oral pain including teething.

Due to the significant safety risk of methemoglobinemia, FDA notified makers of OTC benzocaine oral health products that they should stop marketing these products for treating teething in infants and children younger than 2 years. We have also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to add to include a warning about methemoglobinemia, contraindications stating “do not use” in children under 2 years of age, and update directions for use stating “do not use” in children under 2 years of age on the drug facts label.

FDA is also requiring all prescription local anesthetics, such as lidocaine, to standardize warning information about methemoglobinemia in the prescribing information across this class of drug products.

FDA urges consumers and health care professionals to report adverse reactions involving benzocaine or other medicines to the FDA’s MedWatch program.

FDA will continue to monitor the safety of benzocaine products and will take additional actions if needed.

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Page Last Updated: 06/25/2018
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