Country: Canada
Language: English
Source: Health Canada
BENZOYL PEROXIDE
GLAXOSMITHKLINE INC
D10AE01
BENZOYL PEROXIDE
10%
SOAP BAR
BENZOYL PEROXIDE 10%
TOPICAL
100G
Prescription
KERATOLYTIC AGENTS
Active ingredient group (AIG) number: 0107205003; AHFS:
APPROVED
2010-05-28
_2013-12-20/131-pristine-english-panoxyl.doc _ _ _ _ _ _Page 1 of 12_ 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._ _2013-12-20/131-pristine-english-panoxyl.doc _ _ _ _ _ _Page 2 of 12_ 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. _2013-12-20/131-pristine-english-panoxyl.doc _ _ _ _ _ _Page 3 of 12_ 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 Read the complete document