Chlorhexidine Gluconate (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months.

Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after tooth brushing. Usual dosage is 15 ml (marked in cap) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.

HOW SUPPLIED

Product: 50090-0722

NDC: 50090-0722-0 473 mL in a BOTTLE

DESCRIPTION

//medlibrary.org/lib/images-rx/chlorhexidine-gluconate-21/xt-logo-300x108.jpg
(click image for full-size original)

0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1′-hexamethylene bis [5-(p-chlorophenyl) 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:

1XT logo.jpg1

Chlorhexidine Gluconate

Label ImageLabel Image
CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0722(NDC:0116-2001)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
PEG-40 SORBITAN DIISOSTEARATE
ALCOHOL
SACCHARIN SODIUM
FD&C BLUE NO. 1
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0722-0 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077789 06/01/2010
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-0722)

Revised: 05/2021 A-S Medication Solutions

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.