TRI-LUMA CREAM

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

Disponible depuis:

ZUELLIG PHARMA SDN BHD

DCI (Dénomination commune internationale):

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

Unités en paquet:

3gm mcg/mL; 15gm mcg/mL

Fabriqué par:

Hill Dermaceuticals Inc

Notice patient

TRI-LUMA
TM CREAM
Fluocinolone acetonide/ Hydroquinone/Tretinoin (0.01% w/w / 4% w/w /
0.05% w/w)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What TRI-LUMA Cream is used for
2.
How TRI-LUMA Cream works
3.
Before you use TRI-LUMA Cream
4.
How to use TRI-LUMA Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TRI-LUMA
Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TRI-LUMA CREAM_ _IS USED FOR
TRI-LUMA cream is indicated for short
term intermittent treatment of moderate to
severe melasma (dark skin patches) of the
face, in the presence of measures for sun
avoidance,
including
the
use
of
sunscreens.
HOW TRI-LUMA CREAM_ _WORKS
TRI-LUMA
Cream,
a
combination
of
three
active
ingredients
fluocinolone
acetonide
(anti-inflammatory),
hydroquinone (depigmenting agent) and
tretinoin (form of Vitamin A) that work
together to lighten the dark spots.
BEFORE YOU USE TRI-LUMA CREAM
-
_When you must not use it _
_ _
Do not use TRI-LUMA Cream if you
have a history of hypersensitivity, allergy,
or intolerance to this product or any of its
components.
_ _
Do not use TRI-LUMA Cream
_ _
if you are
pregnant
or
thinking
of
becoming
pregnant.
TRI-LUMA
Cream
contains
tretinoin, which may cause harm to the
baby. Your doctor can give you more
information.
If you are a nursing mother, ask your
doctor or pharmacist for advice before
using any medicine.
-
_Before you start to use it _
Consult your doctor or pharmacist if you
are using any other medicines or topical
creams before using TRI-LUMA Cream.
For
nursing
mother,
avoid
contact
between the baby being nursed and TRI-
LUMA
Cream
during
the
use
of
this
medicine.
-
_Taking other medicines _
_ _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy,
supermarket
or
health
food
shop.
You should avoid medicated or abrasive
cleansers,
soaps
and
cosmetics
with
drying
effects,
products
with
high
concentration of alcohol a

Résumé des caractéristiques du produit

TRI-LUMA Malaysia Package Insert
For External Use Only Not for Ophthalmic Use Rx only
DESCRIPTION:
TRI-LUMA™
Cream
(fluocinolone
acetonide
0.01%,
hydroquinone
4%,
tretinoin
0.05%)
contains
fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in
a hydrophilic cream base for topical application.
Fluocinolone acetonide is a synthetic fluorinated corticosteroid for
topical dermatological use and is classified therapeutically
as an anti-inflammatory. It is a white crystalline powder that is
odourless and stable in light.
The
chemical
name
for
fluocinolone
acetonide
is:(6α-,11β,16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-
methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione.
The molecular formula is C
24
H
30
F
2
O
6
and molecular weight is 452.50.
Fluocinolone acetonide has the following structural formula:
Hydroquinone is classified therapeutically as a depigmenting agent. It
is prepared from the reduction of p-benzoquinone
with sodium bisulfite. It occurs as fine white needles that darken on
exposure to air.
The chemical name for hydroquinone is: 1,4-benzenediol.
The molecular formula is C
6
H
6
O
2
and molecular weight is 110.11.
Hydroquinone has the following structural formula:
Tretinoin is all-trans-retinoic acid formed from the oxidation of the
aldehyde group of retinene to a carboxyl group. It
occurs as yellow to light-orange crystals or crystalline powder with a
characteristic odor of ensilage. It is highly reactive to
light and moisture and should be stored at a cool temperature.
Tretinoin is classified therapeutically as a keratolytic. The
chemical name for tretinoin is:
(all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic
acid. The
molecular formula is C
20
H
28
O
2
and molecular weight is 300.44.
Tretinoin has the following structural formula:
Each gram of TRI-LUMA Cream contains Active: fluocinolone acetonide
0.01% (0.1 mg), hydroquinone 4% (40 mg), and
tretinoin 0.05% (0.5 mg). Inactive: butylated hydroxytoluene, cetyl
alcohol, citric acid, glycerin, m