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DENTI BOUNGIORNO GUM CARE TOOTH

Approved
Approval ID

3495fc79-32b4-249d-e063-6394a90a396e

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85601-030
Product Classification
G
Generic Name
Silica, Sodium Fluoride, Tocopheryl Acetate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (7)

SILICON DIOXIDEActive
Quantity: 15 g in 100 g
Code: ETJ7Z6XBU4
Classification: ACTIB
SODIUM COCOYL GLUTAMATEInactive
Code: BMT4RCZ3HG
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.22 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIM
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEActive
Quantity: 0.2 g in 100 g
Code: 9E8X80D2L0
Classification: ACTIM

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DENTI BOUNGIORNO GUM CARE TOOTH - FDA Drug Approval Details