Chlorhexidine Gluconate
CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP
Approved
Approval ID
fedf45d6-5dc8-4ed5-ad69-3f24ee428366
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3722
Application NumberANDA077789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2010
FDA Product Classification
INGREDIENTS (6)
CHLORHEXIDINE GLUCONATEActive
Quantity: 0.12 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT