PreviDent 5000 Kids
PreviDent 5000 ppm Kids
Approved
Approval ID
29a110f3-f407-fdfa-4346-937269ca849b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2023
Manufacturers
FDA
Colgate Oral Pharmaceuticals, Inc.
DUNS: 968801118
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 Code0126-0311
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (15)
SODIUM FLUORIDEActive
Quantity: 6 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
POLOXAMER 338Inactive
Code: F75JV2T505
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
POLYETHYLENE GLYCOL 600Inactive
Code: NL4J9F21N9
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRICALCIUM PHOSPHATEInactive
Code: K4C08XP666
Classification: IACT