Chlorhexidine Gluconate 0.12% Oral Rinse
Chlorhexidine Gluconate 0.12% Oral Rinse
Approved
Approval ID
3c754532-d9a5-f876-00c4-05a4c9b21efa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2022
Manufacturers
FDA
Sage Products LLC
DUNS: 054326178
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CHLORHEXIDINE GLUCONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53462-003
Application NumberANDA077789
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORHEXIDINE GLUCONATE
Product Specifications
Route of AdministrationBUCCAL
Effective DateMarch 22, 2022
FDA Product Classification
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB