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CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse

Approved
Approval ID

0d950be9-9d25-202c-e063-6294a90ada7d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 28, 2023

Manufacturers
FDA

Safco Dental Supply LLC

DUNS: 020417380

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 Code67239-0225
Application NumberANDA075561
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 28, 2023
FDA Product Classification

INGREDIENTS (7)

CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
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
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

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