CREST ORAL DISCLOSING TABLETS
Received Mar 18, 2009 · Event occurred Feb 18, 2009
Report MW5010380 · MDR key 1346811
Device
Product problems
- Labelling, Instructions for Use or Training Problem
- Nonstandard Device
- Other (for use when an appropriate device code cannot be identified)
Patient
6 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
MY DAUGHTER RECEIVED CREST ORAL DISCLOSING TABLETS FROM HER SCHOOL. NO UNIQUE IDENTIFYING LOGO ON TABLET FACE. NO CHILD RESISTANT PACKAGING. IS THIS PRODUCT REGULATED? COULD NOT FIND IT LISTED IN ORANGE BOOK. IS IT EVEN APPROVED? SOME TABLET INGREDIENTS ARE LISTED BY PROPRIETARY NAME -EMDEX, EXPLOTAB, CHERRY FLAVOR, D&C RED 28 DYE, MAGNESIUM STEARATE- . . . THOSE NAMES WOULD MEAN NOTHING TO A LAY PERSON. DYE ADHERES TO PLAQUE ON TEETH AS INDICATOR OF POOR TEETH BRUSHING. ACCOMPANYING LITERATURE STATES "CREST SUPER TABS" YET PRODUCT FOIL POUCH IS LABELED CREST NON DISCLOSING TABLETS. NOT SURE IF THESE ARE TECHNICALLY CONSIDERED A DRUG/DIAGNOSTIC DEVICE?? I DOUBT IT IS A VITAMIN/FOOD PRODUCT. NO ONE AT THE FDA CAN ANSWER MY QUESTION. FDA SUGGESTED THAT I FILL OUT A MEDWATCH REPORT. LITERATURE STATES TO USE UNDER SUPERVISION OF ADULT YET PRODUCT IS TARGETED TO CHILDREN -1ST GRADE- BY CREST AND IS PACKAGED IN NON-CR PACKAGING. DOSE OR AMOUNT: 1 TABLET. FREQUENCY: AFTER BRUSHING. ROUTE: DENTAL. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: TO SHOW AREAS OF POOR BRUSHING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.