Drugs
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Benzocaine Information
Benzocaine is a local anesthetic. It is the active ingredient in many over-the-counter (OTC) products used to relieve pain in the mouth and gums from a variety of conditions. OTC benzocaine products come in the form of gels, sprays, liquids, and lozenges.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
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Information on Benzocaine Gels and Liquids
FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
4/7/2011FDA Drug Safety Podcast for Healthcare Professionals: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
4/2011Comunicado de la FDA sobre la seguridad de los medicamentos: Informes sobre un efecto adverso raro pero grave y potencialmente fatal del uso de benzocaína en gel o líquido de venta libre que se aplica a las encías o la boca Questions & Answers: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
4/7/2011- Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia
MedWatch Alert (4/7/2011) - Risk of methemoglobinemia in the medicine cabinet -- Patients need to know about benzocaine (PDF - 510KB)
Pharmacy Today article (1/2012) (used with permission from the American Pharmacists Association) Benzocaine and Babies: Not a Good Mix
FDA Consumer Update (5/2012)Caution Required When Using Over-The-Counter Oral Pain Relievers (PDF - 883KB)
Short consumer article (9/2011)- HealthyChildren.org - Teething: 4 to 7 months
Consumer article
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Information on Benzocaine Sprays
FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures
4/7/2011FDA Drug Safety Podcast for Healthcare Professionals: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures
4/2011Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia
MedWatch Alert (4/7/2011)- FDA Denial of Citizen Petition on Benzocaine Spray
2/14/2012 (Click on the pdf icon to view the document) - FDA's Information for Healthcare Professionals: Benzocaine Sprays (PDF - 616KB)
Public Health Advisory: Benzocaine Sprays marketed under different names, including Hurricaine, Topex, and Cetacaine
2/10/2006Patient Safety News: Advisory on Benzocaine Sprays and Methemoglobinemia
FDA Patient Safety News (2006)- Anesthetic Sprays and Methemoglobinemia
FDA Patient Safety News (2003) - ISMP Medication Safety Alert: Benzocaine-containing topical sprays and methemoglobinemia
Institute for Safe Medication Practices (2002)
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Contact FDA
1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
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