FDA-Drug2024-09-18Class III

Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1

Elevate Oral Care
Hazard

LABELING: LABEL MIX-UP.

Sold states
120 direct customers, Nationwide US. No foreign, DOD/VA.
Manufactured in
342 Pike Rd Ste 23, West Palm Beach, FL, United States
Products
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0658-2024

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