TRI-LUMA CREAM

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

Available from:

GALDERMA SINGAPORE PRIVATE LIMITED

ATC code:

D11AX

Dosage:

0.1 mg/g

Pharmaceutical form:

CREAM

Composition:

FLUOCINOLONE ACETONIDE 0.1 mg/g; HYDROQUINONE 40 mg/g; TRETINOIN 0.5 mg/g

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

HILL DERMACEUTICALS, INC.

Authorization status:

ACTIVE

Authorization date:

2004-10-19

Patient Information leaflet

TRI-LUMA SINGAPORE 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: (6·,1‚,16·)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-
methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione.  
The molecular formula is C24H30F2O6 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 C6H6O2 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 C20H28O2 and
molecular weight is 300.44. 
Tretinoin has the following structural formula:  
 

Summary of Product characteristics

TRI-LUMA Singapore 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-[(1methylethylidene)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