Sodium Fluoride and Potassium Nitrate
SODIUM FLUORIDE 5000 ppm Sensitive
Approved
Approval ID
7a051d80-879d-4995-96ef-77b60dad26b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2022
Manufacturers
FDA
Westminster Pharmaceuticals, LLC
DUNS: 079516651
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 Code69367-318
Product Classification
G
Generic Name
Sodium Fluoride and Potassium Nitrate
Product Specifications
Route of AdministrationDENTAL
Effective DateJune 15, 2022
FDA Product Classification
INGREDIENTS (15)
SODIUM FLUORIDEActive
Quantity: 5.8 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
POTASSIUM NITRATEActive
Quantity: 57.5 mg in 1 mL
Code: RU45X2JN0Z
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM PYROPHOSPHATEInactive
Code: O352864B8Z
Classification: IACT
GLYCERIN 2-METHYL ETHERInactive
Code: 3GSZ82L6KV
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
GLYCERIN 1-METHYL ETHERInactive
Code: 4G03VY2NKP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT