PreviDent
Colgate PreviDent5000 ppm
Approved
Approval ID
b028cfff-4946-49e8-b8bb-197ab99d0d35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2019
Manufacturers
FDA
Colgate Oral Pharmaceuticals, Inc.
DUNS: 968801118
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium fluoride and Potassium nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0126-0070
Product Classification
G
Generic Name
Sodium fluoride and Potassium nitrate
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 9, 2019
FDA Product Classification
INGREDIENTS (17)
SODIUM FLUORIDEActive
Quantity: 5.8 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POTASSIUM NITRATEActive
Quantity: 57.5 mg in 1 mL
Code: RU45X2JN0Z
Classification: ACTIB
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
POLYETHYLENE GLYCOL 600Inactive
Code: NL4J9F21N9
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT