FDA-Drug2024-12-25Class II
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.
Keystone Industries
Hazard
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Sold states
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Manufactured in
480 S Democrat Rd, Gibbstown, NJ, United States
Products
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0145-2025Don't want to check this manually?
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