Sodium Fluoride 1.1%
SODIUM FLUORIDE 1.1%DENTAL GEL
Approved
Approval ID
6e021467-08b3-40b3-9a39-2e9d9830085d
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 Code35573-435
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateFebruary 20, 2020
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT