Sodium Fluoride 5000 ppm
SODIUM FLUORIDE 5000 PPM DENTAL CREAM
Approved
Approval ID
a7c63ceb-cd8a-4056-ae69-eb6b59248334
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2022
Manufacturers
FDA
Burel Pharmaceuticals LLC
DUNS: 609436204
Products 1
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 Code35573-434
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateFebruary 20, 2020
FDA Product Classification
INGREDIENTS (12)
SODIUM FLUORIDEActive
Quantity: 5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 12000Inactive
Code: VM53EE110J
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
POTASSIUM PYROPHOSPHATEInactive
Code: B9W4019H5G
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT