RETIN-A CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRETINOIN

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

D10AD01

INN (International Name):

TRETINOIN

Dosage:

0.1%

Pharmaceutical form:

CREAM

Composition:

TRETINOIN 0.1%

Administration route:

TOPICAL

Units in package:

30 G

Prescription type:

Prescription

Therapeutic area:

CELL STIMULANTS AND PROLIFERANTS

Product summary:

Active ingredient group (AIG) number: 0112395004; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-02-02

Summary of Product characteristics

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_RETIN-A_
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_ Product Monograph Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RETIN-A
®
Tretinoin Cream and Gel, Mfr. Std.
Gel 0.025% w/w and 0.01% w/w
Cream 0.1% w/w, 0.05% w/w, 0.025% w/w and 0.01% w/w
COMEDOLYTIC AGENT
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear Blvd. West
Laval (Quebec) H7L 4A8
Canada DATE OF REVISION:
January 24, 2022
Submission Control Number: 255590
®
Registered trademark used under license of Bausch Health Companies.
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_RETIN-A_
_®_
_ Product Monograph Page 2 of 21_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
3
1
INDICATIONS..............................................................................................................
3
1.1.1
Pediatrics
........................................................................................................
3
1.1.2
Geriatrics
........................................................................................................
3
2
CONTRAINDICATIONS
...............................................................................................
3
4
DOSAGE AND ADMINISTRATION
..............................................................................
3
4.2
Recommended Dose and Dosage Adjustment
.................................................... 3
4.4
Administration.....................................................................................................
4
5
OVERDOSAGE
...........................................................................................................
4
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........................ 4
7
WARNINGS AND PRECAUTIONS
..............................................................................
5
7.1
Special Populations
...........