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详细处方信息以本药内容附件PDF文件为准
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部分中文 处方资料（仅供参考）

Tri-Luma® Cream is the only FDA-approved melasma treatment with 3 active ingredients, uniquely combined and more effective than treatments containing only two of the ingredients.

Tri-Luma® Cream is a unique triple-combination topical therapy for the short-term (8-week ) treatment of the dark spots associated with moderate-to-severe facial melasma. Fluocinolone acetonide 0.01% is a mild corticosteroid that reduces inflammation. Hydroquinone 4% is a depigmenting agent that interrupts the formation and synthesis of melanin to help lighten the skin. Tretinoin 0.05% works by increasing the skin cell turnover rate, which helps exfoliate the skin.

Tri-Luma® Cream should always be used in conjunction with sun-avoidance measures, like using sunscreens and wearing protective clothing. Tri-Luma® Cream may improve the appearance of melasma but is not a cure.

IMPORTANT SAFETY INFORMATION

Indication: TRI‐LUMA® Cream is indicated for the short‐ erm (up to 8 weeks) treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance, including the use of sunscreens. Adverse Events: In the controlled clinical trials, the most frequently reported events were redness, peeling, burning, dryness, and itching at the site of application. Warnings/Precautions: TRI‐LUMA® Cream contains sulfites which may cause severe, life‐ hreatening allergic reactions in people allergic to sulfites. TRI‐LUMA® Cream contains hydroquinone, which may cause a gradual blue‐lack darkening of the skin. If you are pregnant, nursing or trying to become pregnant you should not use TRI‐LUMA® Cream. Safety and efficacy have not been established in individuals with darker skin. Reversible HPA axis (adrenal function) suppression may result from exposure to the topical corticosteroid, fluocinolone acetonide, so discontinue use if signs and symptoms of this condition occur. Avoid products that may dry or irritate the skin, such as abrasive cleansers, scrubs, or skin‐peeling agents. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. If exposure cannot be avoided, sunscreen products [SPF 30 or more] and protective apparel should be used.

Tri-Luma®(fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05%

MUST BE REFRIGERATED

NDC 0299-5950-30

Rx Only

NET WT. 30g

GALDERMA

For Topical Use Only. Not for Ophthalmic Use.

Usual dosage: Apply a thin film to affected areas once daily at night. See package insert for complete prescribing information. Each gram contains: Active: fluocinolone acetonide 0.01%(0.1mg), hydroquinone 4%(40mg), and tretinoin 0.05% (0.5 mg). Inactive: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol. Storage: Store in a refrigerator, 2° to 8°C (36° to 46°F). Protect from freezing. See carton closure for lot number and expiration date.

TRI-LUMA(fluocinolone acetonide, hydroquinone, tretinoin)cream, 0.01%/4%/0.05% for topical是一种治疗短期或间歇性中度及重度黑斑病的特效药，安全有效，疗效非常显著，使用8个星期，还你亮丽容颜。

Tri-luma（fluocinolone acetonide, hydroquinone, tretinoin，复合氟轻松/氢醌/维甲酸霜乳霜局部用药）是唯一获得FDA批准用于治疗黄褐斑的药物。包含3种有效成分，共同提供有效的治疗。作用是治愈皮肤，阻断黑色素以增强肤色，并提供维生素A来恢复和保护皮肤。常见的副作用包括痤疮，发红，脱皮和灼伤。

Tri-Luma复合乳霜是一种药物，用于局部治疗与面部中度至重度黄褐斑相关的短期治疗。黄褐斑是一种皮肤病，其特征通常是由于荷尔蒙失调引起的皮肤斑片区域，尤其是脸颊和额头。

批准日期：04/01/2012年04月01日 公司：GALDERMA LABORATORIES, L.P.

TRI-LUMA（复合氟轻松/氢醌/维甲酸霜乳霜[fluocinolone acetonide, hydroquinone, tretinoin]）乳霜，局部使用0.01％/4％/0.05％

美国初次批准：2002年

作用机理

TRI-LUMA乳霜中有效成分治疗黄褐斑的作用机理尚不清楚。 适应症和用途

TRI-LUMA面霜是氟轻松龙皮酮（皮质类固醇），对苯二酚（黑色素合成抑制剂）和维甲酸（类维生素A）的组合，可用于存在中度至重度黄褐斑的短期治疗避免阳光的措施，包括使用防晒霜。

剂量和给药

每天至少在睡前30分钟向患处涂一次薄膜。

白天，使用SPF 30的防晒霜，并穿着防护服。避免阳光直射。

剂量形式和强度 乳霜0.01％/4％/0.05％。每克TRI-LUMA霜含0.1毫克氟轻松的丙酮，40毫克对苯二酚和0.5毫克的维甲酸。

禁忌症

TRI-LUMA Cream禁止用于对本产品或其任何成分过敏的人。

警告和注意事项

TRI-LUMA面霜含有偏亚硫酸氢钠，这是一种亚硫酸盐，可能在易感人群中引起过敏性反应，包括过敏性症状和危及生命的哮喘发作。如果发生过敏反应，哮喘或其他临床上明显的超敏反应，请采取适当的治疗措施并停用TRI-LUMA。

TRI-LUMA面霜含有对苯二酚，可能导致外源性时膜变性，使皮肤逐渐蓝黑变黑，一旦出现，应立即中止治疗。

不良反应 最常见的不良反应（发生率> 5％）是红斑，脱屑，灼热，干燥，瘙痒和痤疮。

在特定人群中的使用 TRI-LUMA面霜含有致畸素，维甲酸，可能导致胚胎胎儿死亡，胎儿生长改变，先天畸形和潜在的神经功能缺损。只有在潜在益处证明对胎儿具有潜在风险的情况下，才应在怀孕期间使用TRI-LUMA乳霜。

包装供应/存储和处理方式

TRI-LUMA乳霜为浅黄色，装在30克铝管中，NDC 0299-5950-30。 储存：保持密闭。 存放在2°-8°C（36°-46°F）的冰箱中。 防止冻结。

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详细处方信息以本药内容附件PDF文件为准
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