Oral B Neutra Foam
Oral B Neutra Foam
Approved
Approval ID
3312267e-a1a0-4935-9edb-5792192018e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2023
Manufacturers
FDA
YOUNG DENTAL MANUFACTURING CO 1, LLC
DUNS: 006309355
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 Code0273-0348
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2023
FDA Product Classification
INGREDIENTS (6)
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
Drug Labeling Information
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 10/7/2015
Indication and Usage
A topically applied foaming solution to aid in the prevention of dental caries.
DESCRIPTION SECTION
LOINC: 34089-3Updated: 10/7/2015
Descrption
Oral-B Neutra-Foam ® is a mint flavored neutral aqueous foaming solution of 2.0% w/w sodium fluoride.
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 10/7/2015
Inactives
Purified water,poloxamer 407, cocamidoprophylbetaine, xylitol, sucralose, flavors.