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Chlorhexidine Gluconate

CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP

Approved
Approval ID

d42b0f1d-8930-4b69-9624-8d6c500caba8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 23, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-025
Application NumberANDA077789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2010
FDA Product Classification

INGREDIENTS (6)

CHLORHEXIDINE GLUCONATEActive
Quantity: 0.12 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Chlorhexidine Gluconate - FDA Drug Approval Details