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FDA Approval

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

CompanyHenry Schein, Inc. (DUNS: 012430880)

Effective Date

June 17, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Chlorhexidine(1.2 mg in 1 mL)

Registrants (1)

Xttrium Laboratories, Inc.

DUNS Number

007470579

Manufacturing Establishments (1)

Xttrium Laboratories, Inc.

Labeler

Henry Schein, Inc.

Registrant

Xttrium Laboratories, Inc.

DUNS Number

007470579

Products (1)

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

NDC Product Code

0404-4075

Application Number

ANDA077789

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 17, 2022

Ingredients

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

PEG-40 SORBITAN DIISOSTEARATEInactive

Code: JL4CCU7I1GClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

ChlorhexidineActive

Code: MOR84MUD8EClass: ACTIBQuantity: 1.2 mg in 1 mL

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