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Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Henry Schein Acclean 4-oz Chlorhexidine Gluconate 0.12% Oral Rinse, USP

Approved
Approval ID

4a2a6bb8-85b0-6c36-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 6, 2022

Manufacturers
FDA

Xttrium Laboratories, Inc.

DUNS: 007470579

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0116-6720
Application NumberANDA077789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate 0.12% Oral Rinse
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2022
FDA Product Classification

INGREDIENTS (7)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/28/2025

NDC 0404-6720-04

REF 112-6720

ACCLEAN ®

Chlorhexidine Gluconate

0.12% Oral Rinse, USP

Anti-Microbial Rinse,

Mint

DIRECTIONS FOR USE: Swish 1 tablespoon (15 ml) in mouth undiluted for 30 seconds, then**spit out.**Use after breakfast and before bedtime. Or, use as prescribed.

NOTE: To minimize medicinal taste, do not rinse with water immediately after use.

KEEP OUT OF REACH OF CHILDREN

1999HS04EZCD

by HENRY SCHEIN®

4 oz. (118 ml)

INGREDIENTS: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1.

To open, press down while turning cap. To reseal, turn cap past "clicks" until tightly locked.

CAUTION, CONSULT ACCOMPANYING DOCUMENTS

Rx Only

Acclean PDP

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DESCRIPTION SECTION

LOINC: 34089-3Updated: 5/21/2025

ACCLEAN is an oral rinse containing 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorphenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:

Chemical Structure

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