Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution BAJAJ MEDICAL, LLC
Approved
Approval ID
d44f4e79-e684-a1ef-e053-2995a90a4620
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
Bajaj Medical, LLC
DUNS: 078774921
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61037-469
Application NumberANDA075561
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Product Specifications
Route of AdministrationDENTAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (7)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT