Overview

• ANMAT reaffirmed that the use, distribution and sale of Colgate Total Clean Mint remain prohibited in Argentina across all presentations, sizes and lots.
• The agency first ordered a nationwide withdrawal on July 22 under Disposición Nº 5126 and issued today’s alert after continued adverse-reaction reports.
• Nearly 11,500 cases were reported in Brazil involving a product with the same formula and manufacturing origin as the units sold in Argentina.
• Reported symptoms include oral lesions, pain, burning or tingling, gum inflammation and lip swelling, with some users incurring medical costs and functional difficulties.
• Coverage links the issue to a recent formulation change involving stannous fluoride under regulatory review, and ANMAT invites reports via its cosmetovigilance form or [email protected].