TOPICORT CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DESOXIMETASONE

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

D07AC03

INN (International Name):

DESOXIMETASONE

Dosage:

0.05%

Pharmaceutical form:

CREAM

Composition:

DESOXIMETASONE 0.05%

Administration route:

TOPICAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0112434002; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-11-10

Summary of Product characteristics

_Pr_
_TOPICORT _
_®_
_ Desoximetasone Cream, Gel and Ointment Product Monograph Page 1 of
23 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TOPICORT
®
Desoximetasone cream, USP
Cream 0.05% w/w and 0.25% w/w
Desoximetasone gel, USP
Gel 0.05% w/w
Desoximetasone ointment, USP
Ointment 0.25% w/w
Topical Corticosteroid
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Initial Authorization:
June 10, 1996
Date of Revision:
May 31, 2022
Submission Control Number: 260348
_ _
_Pr_
_TOPICORT _
_®_
_ Desoximetasone Cream, Gel and Ointment Product Monograph Page 2 of
23 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
05/2022
1 INDICATIONS, 1.1 Pediatrics
05/2022
1 INDICATIONS, 1.2 Geriatrics
05/2022
4 DOSAGE AND ADMINISTRATION
05/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing
Considerations
05/2022
7 WARNINGS AND PRECAUTIONS
05/2022
7 WARNINGS AND PRECAUTIONS, Endocrine and
Metabolism
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
05/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1