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DASH Chlorhexidine Gluconate 0.12% Oral Rinse

Chlorhexidine Gluconate Oral Rinse USP 0.12%

Approved
Approval ID

12a11cd7-5087-4eb8-aa52-4fad402450f7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 4, 2023

Manufacturers
FDA

Natco Pharma USA LLC

DUNS: 079590418

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chlorhexidine Gluconate 0.12% Oral Rinse

PRODUCT DETAILS

NDC Product Code69339-138
Application NumberANDA074291
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 30, 2023
Generic NameChlorhexidine Gluconate 0.12% Oral Rinse

INGREDIENTS (8)

PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB

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DASH Chlorhexidine Gluconate 0.12% Oral Rinse - FDA Drug Approval Details