The agency now wants teething products off the market as it has been alerting people about the products for a decade.
The American Academy of Pediatrics has informed parents to use alternatives such as hard rubber teething products.
The FDA said that benzocaine can have a rare, but serious side effect on children, and especially those under 2 years old.
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.
If you can see that the teeth are breaking through the surface, Logan says you can also give your child a small dose of Tylenol. The over-the-counter benzocaine products is a sample of a product that poses a serious safety risk with not apparent demonstrated benefit. Symptoms include shortness of breath, headache and rapid heart rate.
Federal health officials in the USA warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers. Other Orajel products that are meant for adult use would not be stopped, the spokesperson added.
Benzocaine, a local anesthetic agent is also found in over-the-counter products that are used for mouth sores, mouth ulcers, toothaches, cold sores etc.
The FDA said that if companies that make these products do not stop selling them, it will take regulatory action to get the products out of stores.
Symptoms of methemoglobinemia can happen within minutes of using benzocaine. All drug products, including local anesthetics, should be stored out of reach of children.
If lidocaine is used, healthcare staff should be familiar with appropriate dosing, proper administration techniques, and safety monitoring; benzocaine sprays are not FDA-approved to numb mucous membranes of the mouth and throat or to suppress the gag reflex during medical procedures. In 2011, the agency warned consumers about the methemoglobinemia potential of the products.