Description of Event or Problem · 0
THIS CASE WAS RECEIVED BY COLGATE PALMOLIVE COMPANY FROM A CONSUMER WHO REPORTED REGARDING ONE OF OUR COSMETIC PRODUCT (TOM'S TP NATURAL TODDLER TRAINING) WE HAVE RECORDED THE CASE INTO OUR SAFETY SYSTEM WITH ID "(B)(4)" WE ARE USING MEDWATCH PORTAL TO SUBMIT THIS COSMETIC CASE TO USFDA. THIS IS A SPONTANEOUS REPORT RECEIVED FROM A MOTHER REGARDING HER 2-YEAR-OLD SON ON (B)(6) 2023 WHO USED TOM'S TP NATURAL TODDLER TRAINING AND EXPERIENCED ALLERGIC REACTION, EYES PUFFY AND PALE. THE CHILD'S MEDICAL HISTORY INCLUDED "A LOT OF ALLERGIES" (DAIRY, PEANUTS, SOME TREE NUTS, SESAME, PEACH AND BANANA) AND CELIAC SENSITIVITY. ON (B)(6) 2023, CONSUMER'S SON STARTED USING A NEW TUBE OF TOM'S TP NATURAL TODDLER TRAINING (LOT NO: 3195UST11D) AND USED "A LITTLE BIT LIKE A GRAIN OF RICE" ONLY ONCE TO BRUSH HIS TEETH. ALMOST IMMEDIATELY AFTER BRUSHING, THE CHILD EXPERIENCED AN ALLERGIC REACTION WITH HIS EYES APPEARING PUFFY AND PALE. AN EPIPEN (EPINEPHRINE) WAS ADMINISTERED AT HOME, AND HE WAS TRANSPORTED TO THE EMERGENCY ROOM (ER (EMERGENCY ROOM)). HE WAS MONITORED FOR 4 HOURS AT THE ER (EMERGENCY ROOM). THE MOTHER REPORTED HER SON WAS FEELING BETTER 1 HOUR AFTER RECEIVING EPINEPHRINE. HIS VITALS WERE WITHIN NORMAL LIMITS, AND HE WAS RELEASED TO HOME WHERE HIS MOTHER STATED THAT HE WAS DOING FINE. THE CHILD'S MOTHER REPORTED HE HAD USED TOM'S TOOTHPASTES PREVIOUSLY DUE TO HIS ALLERGIES. TOM'S TP NATURAL TODDLER TRAINING WAS DISCONTINUED AFTER ONE USE. AT THE TIME OF REPORT CONSUMER HAD RECOVERED FROM THE EVENTS.