TARO-BENZOYL PEROXIDE / CLINDAMYCIN KIT GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE); BENZOYL PEROXIDE

Available from:

TARO PHARMACEUTICALS INC

ATC code:

D10AF51

INN (International Name):

CLINDAMYCIN, COMBINATIONS

Dosage:

1%; 5%

Pharmaceutical form:

GEL

Composition:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 1%; BENZOYL PEROXIDE 5%

Administration route:

TOPICAL

Units in package:

10G (CLINDA) & 2 OZ (BENZ. PEROX))

Prescription type:

Prescription

Therapeutic area:

ANTIBIOTICS

Product summary:

Active ingredient group (AIG) number: 0242561001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-05-31

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
TARO-BENZOYL PEROXIDE / CLINDAMYCIN KIT
TOPICAL GEL
benzoyl peroxide and clindamycin gel, 5% / 1%, w/w
(as clindamycin phosphate)
Acne Vulgaris Therapy
ATC Code: D10AF
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
August 17, 2018
Submission Control No.: 216759
_Page 2 of 20_
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
...........................................................................................................
6
DOSAGE AND ADMINISTRATION
.......................................................................................
7
OVERDOSAGE
.........................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
8
STORAGE AND STABILITY
...................................................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 8
PART II: SCIENTIFIC INFORMATION
.................................................................................
9
PHARMACEUTICAL INFORMATION
...................................................................................
9
CLINICAL TRIALS
.................................................