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Benzocaine
Trade Name:
Orajel teething products
Manufacturer/Distributor:
Church & Dwight
Status:
discontinued
Date Marketed in Canada (yyyy/mm/dd):
2018/05/23
Presentation:
Liquid: regular strength 7.5%. NPN:02229697
Gel: regular strength 7.5%. NPN: 00075876
Gel: extra strength for nighttime 10%. NPN: 02256401
Comments:
Based on the May 23, 2018 communication from the U.S. Food and Drug Administration (FDA) regarding over-the-counter (OTC) teething products containing benzocaine, the company is proactively discontinuing the distribution and sale of Orajel™ teething products containing benzocaine. Orajel™ teething products containing benzocaine and labeling have complied with applicable Health Canada and FDA requirements since the company acquired the brand in 2008. The discontinuation is effective immediately and includes Orajel™ Regular Strength Gel for Teething (9.5G) and Orajel™ Extra Strength Gel for Nighttime (9.5G).
Further Information:
Health Canada safety information: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2012/13671a-eng.php
FDA Communication: https://www.fda.gov/Drugs/DrugSafety/ucm608265.htm
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