DENTI BOUNGIORNO PLAQUE CARE TOOTH
Approved
Approval ID
3488b090-c30d-e6d2-e063-6294a90a3569
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
ATOSAFE CO., Ltd
DUNS: 688995680
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Silica, Sodium Fluoride, Tocopheryl Acetate, Tetrasodium Pyrophosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code85601-020
Product Classification
G
Generic Name
Silica, Sodium Fluoride, Tocopheryl Acetate, Tetrasodium Pyrophosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (8)
SODIUM PYROPHOSPHATEActive
Quantity: 0.5 g in 100 g
Code: O352864B8Z
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SILICON DIOXIDEActive
Quantity: 17 g in 100 g
Code: ETJ7Z6XBU4
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.22 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIM
SODIUM COCOYL GLUTAMATEInactive
Code: BMT4RCZ3HG
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEActive
Quantity: 0.2 g in 100 g
Code: 9E8X80D2L0
Classification: ACTIM