CONTRAINDICATIONS Coresatin® Nonsteroidal Cream – Theraphy for Dermatitis nonsteroidal skin repair barrier cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PRECAUTIONS Coresatin® Nonsteroidal Cream – Therapy for Dermatitis is a soothing skin repair barrier cream that promotes skin’s natural healing process. It is specially formulated with allantoin, natural seabuckthorn oil, peppermint oil, vitamin B6 , vitamin E and panthenol. Patients who have been diagnosed with a form of dermatitis have skin barrier dysfunctionality. Skin’s defense functions are localized in the stratum corneum layer; a brick wall, with the corneocytes as bricks and lipid lamellae acting as mortar. It has approximately nine to fifteen corneocyte cell layers that consist of packing of keratin filaments and filaggrin of corneodesmosomes. The lipid lamellae consist of 50% ceramide, 25% cholesterol, and long-chain free fatty acids. When a patient is genetically predisposed to have mutations in the filaggrin gene, together with environmental offenders, patient’s skin barrier function is easily compromised due to functionality loss of the stratum corneum. As a result, sphingosine, (a ceramide metabolite that exhibits antimicrobial activity in vitro) is no longer active; this in return predisposes patient’s skin to pathogen colonization. Coresatin® Nonsteroidal Cream – Therapy for Dermatitis works by restoring this functionality to the stratum corneum with proprietary composition. Its special formulation forms a film over the surface of the affected areas on the skin and prevents excess evaporation of water, keeping it well moisturized and smooth, promoting the healing process. Skin is no longer permeable to irritants, allergens, and microorganisms. Coresatin® controls the scaling and irritation of the skin and improves pruritus. Coresatin®Nonsteroidal Cream – Therapy for Dermatitis restores skin’s natural barrier and comfort level. INDICATIONS Coresatin® Nonsteroidal Cream – Therapy for Dermatitis is indicated for of all types of dermatitis (contact dermatitis, atopic dermatitis, seborrheic dermatitis) that present with skin rashes, lesions, erythema (redness), irritation, pruritus (itching) and discomfort related with skin barrier dysfunctionality. Coresatin® Nonsteroidal Cream – Therapy for Dermatitis is indicated for insect bites. Coresatin®’s cortisone-free formula is safe for daily use and is also recommended as a preventive therapy for bacterial and fungal infections for patients who are diagnosed with dermatitis. • For external use only. • Read the package insert (US)/patient information leaflet (EU) carefully before using the product. • When using this product avoid eye contact, in case of eye contact rinse eyes thoroughly with water. • Stop use and consult your doctor if local irritation/rash occurs or your condition worsens after regular use of this product as directed. • Keep out of sight and reach of children. • Coresatin® does not protect against sun damage. Use of a broad range sunscreen is recommended while using this product. DIRECTIONS TO USE Apply to the affected area 3 to 6 times daily depending on the severity of the condition, massaging gently into the skin. HOW SUPPLIED Coresatin® Nonsteroidal Cream - Therapy for Dermatitis is supplied in 30 gram tubes . STORAGE Store at room temperature 20°–25°C (68°–77°F). Keep the tube tightly closed Protect from freezing. Store away from heat. Contact your doctor or pharmacist for any other questions. For topical dermatological use only. Coresatin® Nonsteroidal Cream –Therapy for Dermatitis is classified as Class IIa medical device according to 93/42/EEC. www.coresatin.com 0029 Corena Therapeutics Sarl. Avenue de la Gare 2 Neuchatel - Switzerland Rev.02/09.01.2014