SPECTRO ECZEMACARE MEDICATED CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOBETASONE BUTYRATE

Available from:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC code:

D07AB01

INN (International Name):

CLOBETASONE

Dosage:

0.05%

Pharmaceutical form:

CREAM

Composition:

CLOBETASONE BUTYRATE 0.05%

Administration route:

TOPICAL

Units in package:

30G

Prescription type:

OTC

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0113261001; AHFS:

Authorization status:

APPROVED

Authorization date:

2002-02-04

Summary of Product characteristics

_ September 2019 _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SPECTRO ECZEMACARE MEDICATED CREAM
Clobetasone Cream, B.P., 0.05% w/w
Topical Corticosteroid
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, ON
L5N 6L4
Date of Revision:
September 27, 2019
Submission Control No: 221795
_ _
_September 2019 _
_Page 2 of 26_
TABLE OF CONTENTS
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
DOSAGE AND ADMINISTRATION
................................................................................
4
3.1
Dosage
..................................................................................................................
4
3.2
Administration
........................................................................................................
5
4
OVERDOSAGE
...............................................................................................................
5
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 5
6
WARNINGS AND PRECAUTIONS
.................................................................................
6
6.1
Special Populations
...............................................................................................
8
6.1.1
Pregnant Women
...............................................................................