Burkhart
Approved
Approval ID
47142a7d-3095-4ea6-b977-80e9f2cc8958
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2022
Manufacturers
FDA
Burkhart Dental Supply Inc
DUNS: 027532357
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Stannous Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43498-201
Product Classification
G
Generic Name
Stannous Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateFebruary 2, 2022
FDA Product Classification
INGREDIENTS (5)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 0.3408 g in 284 g
Code: 3FTR44B32Q
Classification: ACTIM