BACTROBAN CREAM
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-02-2017
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Active ingredient:
MUPIROCIN (MUPIROCIN CALCIUM)
Available from:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
ATC code:
D06AX09
INN (International Name):
MUPIROCIN
Dosage:
2%
Pharmaceutical form:
CREAM
Composition:
MUPIROCIN (MUPIROCIN CALCIUM) 2%
Administration route:
TOPICAL
Units in package:
15G
Prescription type:
OTC
Therapeutic area:
ANTIBIOTICS
Product summary:
Active ingredient group (AIG) number: 0117081001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2020-07-24
Summary of Product characteristics
_ _
_Product Monograph: _
_July 6, 2016_
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
BACTROBAN
® CREAM
Mupirocin Cream USP 2% (w/w) as mupirocin calcium
TOPICAL ANTIBIOTIC
GlaxoSmithKline Consumer Healthcare Inc
7333 Mississauga Road North
Mississauga, Ontario
L5N 6L4
Date of Preparation:
July 6, 2016
Submission Control No: 194464
® Bactroban is a registered trademark, used under license by
GlaxoSmithKline Consumer Healthcare Inc.
_ _
_Product Monograph: _
_July 6, 2016_
_ _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
..........................................................................................10
SPECIAL HANDLING INSTRUCTIONS
.......................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
...............................................................................11
PHARMACEU
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