The Mentholatum Co.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1541-2020Class IIIRed Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle July 31, 2020
D-0018-2016Class IIWellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large PatcheSeptember 17, 2015
D-1037-2014Class IIROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13January 16, 2014
D-1040-2014Class IIROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness ReJanuary 16, 2014
D-1041-2014Class IIROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mJanuary 16, 2014
D-1039-2014Class IIROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 January 16, 2014
D-1038-2014Class IIROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 January 16, 2014