KOLORZ SIXTY SECOND FLUORIDE
kolorz Sixty Second Fluoride Gel
Approved
Approval ID
21fa26f2-0162-4044-aec0-d5360be3f3e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2019
Manufacturers
FDA
DMG AMERICA, LLC
DUNS: 106792427
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25047-775
Product Classification
G
Generic Name
SODIUM FLUORIDE
Product Specifications
Route of AdministrationDENTAL
Effective DateMarch 28, 2019
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIB
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25047-774
Product Classification
G
Generic Name
SODIUM FLUORIDE
Product Specifications
Route of AdministrationDENTAL
Effective DateMarch 28, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIB
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25047-771
Product Classification
G
Generic Name
SODIUM FLUORIDE
Product Specifications
Route of AdministrationDENTAL
Effective DateMarch 28, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIB
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25047-772
Product Classification
G
Generic Name
SODIUM FLUORIDE
Product Specifications
Route of AdministrationDENTAL
Effective DateMarch 28, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25047-773
Product Classification
G
Generic Name
SODIUM FLUORIDE
Product Specifications
Route of AdministrationDENTAL
Effective DateMarch 28, 2019
FDA Product Classification
INGREDIENTS (5)
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT