Methemoglobinemia Warning OK’d for Benzocaine Products

The FDA announced that it will allow manufacturers of over-the-counter (OTC) oral health care products containing benzocaine to include a product label warning regarding the risks of methemoglobinemia associated with these products.

The decision is based on a request from the Consumer Healthcare Products Association in 2012 for the FDA to exercise enforcement discretion for methemoglobinemia warnings on the labels for OTC oral benzocaine products in liquid, spray, lozenge, and topical gel forms. Currently, this warning is outside the current label specifications in the FDA’s Tentative Final Monograph for Oral Health Care Drug Products for OTC Use but the agency will not object the addition of this warning to product labels.

RELATED: FDA Warns of Methemoglobinemia with Benzocaine Topical Products

The approved warning states that use of these products may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Consumers are advised to cease use and seek immediate medical attention if they or a child in their care develop:

  • Pale, gray, or blue colored skin (cyanosis)
  • Headache
  • Rapid heart rate
  • Shortness of breath
  • Dizziness or lightheadedness
  • Fatigue or lack of energy

Benzocaine is an anesthetic indicated for oral mucosa in individuals ≥4 months of age. The FDA may change or reverse this decision as new information about OTC products containing benzocaine and methemoglobinemia becomes available.

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