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Indications And Usage (To Understand Fully The Indication For This Product, Please Read The Entire Indications And Usage Section Of The Labeling.) Refissa [Tretinoin Cream, Usp (Emollient) 0.05%] Is Indicated As An Adjunctive Agent (See Second Bullet Point Below) For Use In The Mitigation (Palliation) Of Fine Wrinkles, Mottled Hyperpigmentation, And Tactile Roughness Of Facial Skin In Patients Who Do Not Achieve Such Palliation Using Comprehensive Skin Care And Sun Avoidance Programs (See Bullet 3 For Populations In Which Effectiveness Has Not Been Established). Refissa Does Not Eliminate Wrinkles, Repair Sun-Damaged Skin, Reverse Photoaging, Or Restore A More Youthful Or Younger Dermal Histologic Pattern. Many Patients Achieve Desired Palliative Effects On Fine Wrinkling, Mottled Hyperpigmentation, And Tactile Roughness Of Facial Skin With The Use Of Comprehensive Skin Care And Sun Avoidance Programs Including Sunscreens, Protective Clothing, And Emollient Creams Not Containing Tretinoin. Tretinoin Cream, Usp (Emollient) 0.05% Has Demonstrated No Mitigating Effect On Significant Signs Of Chronic Sun Exposure Such As Coarse Or Deep Wrinkling, Skin Yellowing, Lentigines, Telangiectasia, Skin Laxity, Keratinocytic Atypia, Melanocytic Atypia, Or Dermal Elastosis. Refissa Should Be Used Under Medical Supervision As An Adjunct To A Comprehensive Skin Care And Sun Avoidance Program That Includes The Use Of Effective Sunscreens (Minimun Spf Of 15) And Protective Clothing When Desired Results On Fine Wrinkles, Mottled Hyperpigmentation, And Roughness Of Facial Skin Have Not Been Achieved With A Comprehensive Skin Care And Sun Avoidance Program Alone. The Effectiveness Of Refissa [Tretinoin Cream, Usp (Emollient) 0.05%] In The Mitigation Of Fine Wrinkles, Mottled Hyperpigmentation, And Tactile Roughness Of Facial Skin Has Not Been Established In People Greater Than 50 Years Of Age Or In People With Moderately To Heavily Pigmented Skin. In Addition, Patients With Visible Actinic Keratoses And Patients With A History Of Skin Cancer Were Excluded From Clinical Trials Of Tretinoin Cream, Usp (Emollient) 0.05%. Thus The Effectiveness And Safety Of Refissa In These Populations Are Not Known At This Time. Neither The Safety Nor The Effectiveness Of Refissa For The Prevention Or Treatment Of Actinic Keratoses Or Skin Neoplasms Has Been Established. Neither The Safety Nor The Efficacy Of Using Refissa Daily For Greater Than 48 Weeks Has Been Established, And Daily Use Beyond 48 Weeks Has Not Been Systematically And Histologically Investigated In Adequate And Well-Controlled Trials. (See Warnings Section.)
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