PANOXYL AQUAGEL 2.5%

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BENZOYL PEROXIDE

Available from:

GLAXOSMITHKLINE INC

ATC code:

D10AE01

INN (International Name):

BENZOYL PEROXIDE

Dosage:

2.5%

Pharmaceutical form:

GEL

Composition:

BENZOYL PEROXIDE 2.5%

Administration route:

TOPICAL

Units in package:

60G

Prescription type:

OTC

Therapeutic area:

KERATOLYTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0107205004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2012-02-27

Summary of Product characteristics

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PRESCRIBING INFORMATION
PANOXYL™ 5 GEL
benzoyl peroxide gel USP, 5% w/w
PR
PANOXYL™ 10, 20 GEL
benzoyl peroxide gel USP, 10%, 20%, w/w
PANOXYL™ AQUAGEL 2.5%, 5%
benzoyl peroxide gel USP, 2.5%, 5%, w/w
PANOXYL™ WASH 5%
benzoyl peroxide lotion 5% w/w
PANOXYL™ 5 BAR
benzoyl peroxide soap 5% w/w
ACNE THERAPY
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.stiefel.ca
Date of Revision:
December 8, 2011
Submission Control No: 149066
_©_
_ 2011 GlaxoSmithKline Inc. All Rights Reserved_
_™ PANOXYL is a trademark of Stiefel Laboratories, Inc., used under
license by GlaxoSmithKline Inc._
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PANOXYL™ 5 GEL
benzoyl peroxide gel USP, 5% w/w
PR
PANOXYL
TM 10, 20 GEL
benzoyl peroxide gel USP, 10%, 20%, w/w
PANOXYL™ AQUAGEL 2.5%, 5%
benzoyl peroxide gel USP, 2.5%, 5%, w/w
PANOXYL
TM WASH 5%
benzoyl peroxide lotion 5% w/w
PANOXYL
TM 5 BAR
benzoyl peroxide soap 5% 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,