NERISALIC OILY CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIFLUCORTOLONE VALERATE; SALICYLIC ACID

Available from:

GLAXOSMITHKLINE INC

ATC code:

D07XC04

INN (International Name):

DIFLUCORTOLONE

Dosage:

0.1%; 3.0%

Pharmaceutical form:

CREAM

Composition:

DIFLUCORTOLONE VALERATE 0.1%; SALICYLIC ACID 3.0%

Administration route:

TOPICAL

Units in package:

30G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0224404001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2012-02-21

Summary of Product characteristics

_2010-04-23/131-pristine-english-Nerisalic.doc _
_Page 1 of 14 _
PRODUCT MONOGRAPH
NERISALIC
®
(0.1% diflucortolone valerate and 3% salicylic acid)
OILY CREAM
THERAPEUTIC CLASSIFICATION
TOPICAL CORTICOSTEROID-KERATOLYTIC
GlaxoSmithKline Inc.
Date of Preparation:
7333 Mississauga Road
May 11, 2010
Mississauga, Ontario
L5N 6L4
www.stiefel.ca
Control Number: 138393
_©_
_2010 GlaxoSmithKline Inc., All Rights Reserved _
_®_
_NERISALIC used under license by GlaxoSmithKline Inc. _
_2010-04-23/131-pristine-english-Nerisalic.doc _
_Page 2 of 14 _
PRODUCT MONOGRAPH
NERISALIC
®
(0.1% diflucortolone valerate and 3% salicylic acid)
OILY CREAM
THERAPEUTIC CLASSIFICATION
TOPICAL CORTICOSTEROID-KERATOLYTIC
ACTIONS AND CLINICAL PHARMACOLOGY
NERISALIC
®
(0.1% diflucortolone valerate and 3% salicylic acid) Oily Cream
combines
the anti-inflammatory, anti-pruritic and vasoconstrictive activity of
diflucortolone valerate
and the keratolytic effects of salicylic acid.
Both diflucortolone valerate and its split ester are topically active.
INDICATIONS AND CLINICAL USE
NERISALIC
®
(0.1% diflucortolone valerate and 3% salicylic acid) Oily Cream is
indicated
in the topical treatment of chronic eczema, psoriasis vulgaris,
neuro-dermatitis and scaly
crusty dermatoses which respond to corticosteroid therapy.
NERISALIC
®
Oily Cream is not suitable for the treatment of perioral dermatitis
and
rosacea.
CONTRAINDICATIONS
NERISALIC
®
(0.1%
diflucortolone
valerate
and
3%
salicylic
acid)
Oily
Cream
is
contraindicated in patients who have shown hypersensitivity, allergy
or intolerance to
diflucortolone valerate or other corticosteroids or salicylic acid or
to any excipients in the
preparation. NERISALIC
®
Oily Cream should not be applied to skin areas with fissures,
erosions, scratches or excoriations.
_2010-04-23/131-pristine-english-Nerisalic.doc _
_Page 3 of 14 _
Topical steroids are contraindicated in untreated bacterial and/or
fungal skin infections.
Topical steroids should not be applied in cases of tuberculosis of the
skin, or syphilit