DIFFERIN CREAM 0.1%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ADAPALENE

Available from:

GALDERMA SINGAPORE PRIVATE LIMITED

ATC code:

D10AD03

Dosage:

0.10%

Pharmaceutical form:

CREAM

Composition:

ADAPALENE 0.1%

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

LABORATOIRES GALDERMA

Authorization status:

ACTIVE

Authorization date:

1999-09-16

Patient Information leaflet

Product code: P22660-3
Product description: DIFFERIN
Market: EX2
Article: Leaflet
Flat size: 135x210
Fold size: 135x26,25
_LAUNCHING DEPARTMENT - Z.I. Galderma_
_74540 ALBY-SUR-CHERAN - FRANCE_
PMS 432U
DIELINES
Artwork approved by:
Date:
Signature:
Pharmacode: 349
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DIFFERIN
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A D A P A L E N E  
G E L   A N D   C R E A M
PRODUCT INFORMATION
COMPOSITION
Differin Gel contains 0.1% w/w adapalene (BAN, INN, USAN), as the active ingredient in a gel base containing carbomer, propylene
glycol, poloxamer 182, disodium edetate, methyl parahydroxybenzoate, phenoxyethanol, sodium hydroxyde to adjust the pH to 5 and
purified water to complete the formulation.
Differin Cream contains 0.1% w/w adapalene (BAN, INN, USAN), as the active ingredient in a cream base containing carbomer, PEG-20
methylglucose sesquistearate, glycerol, natural squalane, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium
edetate, methylglucose sesquistearate, phenoxyethanol, cyclomethicone, sodium hydroxide to adjust the pH to 6.5 ± 0.2 and purified
water to complete the formulation.
PHARMACOLOGICAL PROPERTIES
Adapalene is a retinoid-like compound which, in _in vivo _and _in vitro _models of inflammation, has been demonstrated to possess anti-
inflammatory properties; Adapalene is essentially stable to oxygen and light and is chemically non-reactive. Mechanistically, adapalene
binds like tretinoin to specific retinoic acid nuclear receptors but, unlike tretinoin, not to cytosolic receptor binding proteins.
Adapalene applied cutaneously is comedolytic in the rhino mouse model and 

Summary of Product characteristics

D I F F E R I N
®
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C R E A M
NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
Product code: MOCK UP
Product description: DIFFERIN CRE
Market: EX2
Article: Leaflet
Flat size: 180x315
Font size: 10 pt
Fold size: 180x26,25
Pharmacode: TBD
DIELINES
PMS 432U
_GRAPHIC DESIGNER: Guillaume ANDRÉ_
_INDUSTRIALIZATION DEPARTMENT_
_LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE_
PRODUCT INFORMATION
COMPOSITION
Differin Cream contains 0.1% w/w adapalene (BAN, INN, USAN), as the
active ingredient in a cream base containing carbomer, PEG-20
methylglucose
sesquistearate,
glycerol,
natural
squalane,
methyl
parahydroxybenzoate,
propyl
parahydroxybenzoate,
disodium
edetate,
methylglucose
sesquistearate, phenoxyethanol, cyclomethicone, sodium hydroxide to
adjust the pH to 6.5 ± 0.2 and purified water to complete the
formulation.
PHARMACOLOGICAL PROPERTIES
Adapalene is a retinoid-like compound which, in _in vivo_ and _in
vitro_ models of inflammation, has been demonstrated to possess
antiinflammatory
properties; Adapalene is essentially stable to oxygen and light and is
chemically non-reactive. Mechanistically, adapalene binds like
tretinoin to
specific retinoic acid nuclear receptors but, unlike tretinoin, not to
cytosolic receptor binding proteins. Adapalene applied cutaneously is
comedolytic
in the rhino mouse model and also has effects on the abnormal
processes of epidermal keratinization and differentiation, both of
which are present
in the pathogenesis of acne vulgaris. The mode of action of adapalene
is suggested to be a normalisation of differentiation of follicular
epithelial
cells resulting in decreased microcomedone formation.
Adapalene is superior to reference retinoids in standard
anti-inflammatory assays, both _in vivo_ and _in vitro_.
Mechanistically, it inhibits chemotactic and
chemokinetic responses of human polymorphonuclear leucocytes and also
the metabolism by lipoxidation of arachidonic acid to pro-inflammatory
mediators. This profile suggests that the cell mediated