Tretinoin cream, USP (emollient) 0.05%, 20 g and 40 g tube
Active Ingredients:tretinoin cream, USP
Indications and Usage:
Refissa® is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patient who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone. Neither the safety nor the effectiveness of Tretinoin Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established. (Please see third bullet point in this section of the full prescribing information for additional populations in which effectiveness has not been established.) Refissa® DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTO-AGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Refissa® should only be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sunscreens (minimum 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. Neither the safety nor the efficacy of using TREINOIN CREAM, USP (EMOLLIENT) 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 wellcontrolled trials.
Side Effects and Contraindications:
Adverse Reactions: Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy.
Contraindications: This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.
Suneva Medical, Inc.
Clinical Pearls & Key Features:
- The only branded tretinoin cream with a 0.05% strength, fragrance-free, emollient base on the market today with a broad indication for fine facial lines, hyperpigmentation and tactile roughness.
- Refissa® should be applied once a day to the face, preferably before bed. Instruct the patient to only use enough to cover the affected area. A pea-sized amount of cream can cover the entire face.
"Retinoids have by far the greatest level of evidence of any cosmetic supporting their use as an anti-aging agent. One of the limiting factors is the anticipated 'retinoid dermatitis' experience by most, if not all, users. The emollient base employed by Refissa® helps compensate for the expected irritation and dryness experienced with the tretinoin, enhancing patient compliance and ultimately efficacy."
Adam Friedman, MD, FAAD
Assistant Professor of Medicine (Dermatology)/Physiology and Biophysics
Director of Dermatologic Research
Montefiore - Albert Einstein College of Medicine