Country: Canada
Language: English
Source: Health Canada
DESOXIMETASONE
BAUSCH HEALTH, CANADA INC.
D07AC03
DESOXIMETASONE
0.05%
GEL
DESOXIMETASONE 0.05%
TOPICAL
15G/50G
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0112434002; AHFS:
APPROVED
2000-11-10
_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 ................................................................................... 2 TABLE OF CONTENTS ......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.............................................................. 4 1 INDICATIONS............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .............................................................................................. 4 4 DOSAGE AND ADMINISTRATION ............................................................................. 4 4.1 Read the complete document