Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
ZUELLIG PHARMA SDN BHD
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
3gm mcg/mL; 15gm mcg/mL
Hill Dermaceuticals Inc
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 Přečtěte si celý dokument
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 Přečtěte si celý dokument