CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATE ORAL RINSE USP 0.12%
Approved
Approval ID
0348006f-b818-4465-a896-bc0d42294cf4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2019
Manufacturers
FDA
Lyne Laboratories, Inc.
DUNS: 053510459
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 Code0374-5080
Application NumberANDA074291
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorhexidine gluconate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2019
FDA Product Classification
INGREDIENTS (10)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB