Published 09 April 2012
Health Canada has requested Canadian companies to add new risk statements to the packaging and labeling of licensed benzocaine products, to raise awareness of the risks associated with the products.
The risks include a very rare but serious blood condition known as methemoglobinemia that can affect sensitive individuals and the statements provide added instructions with respect to the risk of methemoglobinemia and for safe product use. They also provide guidance on recognizing the signs and symptoms of methemoglobinemia, and child safety.
According to the federal department, the new packaging and labeling will affect products including gels, sprays, swabs, liquids and lotions but not lozenges containing benzocaine, as they are not linked to a risk of methemoglobinemia.
The labels will include the problem symptoms, which include weakness, confusion, headache, difficulty breathing or pale, gray or blue-colored skin and will warn people to stop using the product and seek medical attention if any of the symptoms arise.
Companies are requested to add statements to product packages and labels if they do not already appear, to ensure consistency in the labeled information and to help consumers use these products more safely. Depending on product type, exact wording for some statements may vary.
The label changes will be implemented by the companies over the next six months, during which the products that may not have the updated precautionary statements can remain available on store shelves.
Most benzocaine products, which are also used in healthcare settings during surgical, dental and other medical procedures are available over-the-counter in a range of formulations including gels, sprays, swabs, liquids, lotions, lozenges.
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