PANOXYL 10 GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BENZOYL PEROXIDE

Available from:

GLAXOSMITHKLINE INC

ATC code:

D10AE01

INN (International Name):

BENZOYL PEROXIDE

Dosage:

10%

Pharmaceutical form:

GEL

Composition:

BENZOYL PEROXIDE 10%

Administration route:

TOPICAL

Units in package:

60G

Prescription type:

Prescription

Therapeutic area:

KERATOLYTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0107205003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-10-01

Summary of Product characteristics

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PRESCRIBING INFORMATION
PR
PANOXYL
® 10, 20 GEL
benzoyl peroxide gel USP, 10%, 20%, w/w
PANOXYL
® WASH 5%
benzoyl peroxide lotion 5% w/w
PANOXYL
® 5 BAR
benzoyl peroxide soap 5% w/w
PR
PANOXYL
® 10 BAR
benzoyl peroxide soap 10% w/w
ACNE THERAPY
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.stiefel.ca
Date of Revision:
December 20, 2013
Submission Control No: 169917
_©_
_ 2013 GlaxoSmithKline Inc. All Rights Reserved_
_®_
_PANOXYL is a registered trademark of Stiefel Laboratories, Inc., used
under license by GlaxoSmithKline Inc._
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PR
PANOXYL
® 10, 20 GEL
benzoyl peroxide gel USP, 10%, 20%, w/w
PANOXYL
® WASH 5%
benzoyl peroxide lotion 5% w/w
PANOXYL
® 5 BAR
benzoyl peroxide soap 5% w/w
PR
PANOXYL
® 10 BAR
benzoyl peroxide soap 10% w/w
THERAPEUTIC CLASSIFICATION
Acne therapy
ACTION AND CLINICAL PHARMACOLOGY
Benzoyl peroxide is a highly lipophilic oxidizing agent with
bacteriocidal activity
against
_Propionibacterium acnes_ (_P. acnes_) which is present in the
acne-affected
pilosebaceous unit. Additionally, benzoyl peroxide has demonstrated
keratolytic
effects.
INDICATIONS AND CLINICAL USE
PANOXYL
®
(benzoyl peroxide USP) is indicated for the treatment of mild to
moderate acne vulgaris.
CONTRAINDICATIONS
PANOXYL
®
is contraindicated in patients with known hypersensitivity to benzoyl
peroxide or to any of the ingredients
in the formulation. For a complete listing,
see Description and Composition section.
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WARNINGS AND PRECAUTIONS
For external use only. Contact with the eyes, eyelids, mouth, lips,
other mucous
membranes (i.e., nostrils) and broken skin should be avoided. If
contact occurs,
rinse thoroughly with water.
During the first weeks of treatment, a sudden increase in peeling and
reddening
will occur in most patients and will normally subside in a day or two
if trea