FDA-Drug2024-02-07Class II

OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.

Den-Mat Holdings, LLC
Hazard

CGMP Deviations: products may not conform to the labeled specifications.

Sold states
Nationwide in the US
Affected count
344 tubes
Manufactured in
1017 W Central Ave, Lompoc, CA, United States
Products
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0286-2024

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