ODAN-BENZYDAMINE MOUTHWASH/GARGLE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BENZYDAMINE HYDROCHLORIDE

Available from:

ODAN LABORATORIES LTD

ATC code:

A01AD02

INN (International Name):

BENZYDAMINE

Dosage:

0.15%

Pharmaceutical form:

MOUTHWASH/GARGLE

Composition:

BENZYDAMINE HYDROCHLORIDE 0.15%

Administration route:

BUCCAL

Units in package:

250ML

Prescription type:

Prescription

Therapeutic area:

MOUTHWASHES AND GARGLES

Product summary:

Active ingredient group (AIG) number: 0113801001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-04-13

Summary of Product characteristics

_Product Monograph –ODAN-BENZYDAMINE_
_Page 1 of 13_
PRODUCT MONOGRAPH
PR
ODAN-BENZYDAMINE
Benzydamine Mouthwash, BP
benzydamine hydrochloride 1.5 mg/mL (0.15% w/v)
LOCAL ANALGESIC
Odan Laboratories Limited
325 Stillview Avenue
Pointe-Claire, QC,
Canada, H9R 2Y6
Date of Preparation:
April 13, 2017
Submission Control No: 189026
_Product Monograph –ODAN-BENZYDAMINE_
_Page 2 of 13_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
DOSAGE AND ADMINISTRATION
................................................................................4
OVERDOSAGE
..................................................................................................................4
ACTION AND CLINICAL PHARMACOLOGY
..............................................................5
STORAGE AND STABILITY
............................................................................................5
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................5
PART II: SCIENTIFIC INFORMATION
.................................................................................6
PHARMACEUTICAL
INFORMATION............................................................................6
CLINICAL TRIALS
............................................................................................................7
DETAILED PHARMACOLOGY
.......................................................................................7
TOXICOLOGY
.......................................................................................................