Acclean Chlorhexidine Gluconate 0.12% Oral Rinse
Approved
Approval ID
f4d86f9d-2a8d-35ea-e053-2995a90a6fe5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Henry Schein, Inc.
DUNS: 012430880
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 Code0404-0178
Application NumberANDA075561
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationDENTAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (7)
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT