Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Trigen Laboratories, Inc.
TOPICAL
TL-CermideTM Skin Emulsion is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatitis, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. TL-CermideTM Skin Emulsion helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. TL-CermideTM Skin Emulsion is contraindicated in persons with known hypersensitivity to any of the components of the formulation. Apply a thin layer to the affected areas 2 times per day (or as needed) and massage gently into the skin. If the skin is broken, cover TL-CermideTM Skin Emulsion, with a dressing of choice.
TL-CermideTM Skin Emulsion is available in a 90-gram tube. Product Code: 13811-566-90 STORAGE Store at controlled room temperature 15°C - 30°C (59°F - 86°F). [See USP]. Do not freeze. Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436). KEEP OUT OF THE REACH OF CHILDREN. Rx Only - Prescription Medical Device: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Manufactured for TRIGEN Laboratories, Inc. Sayreville, NJ 08872 www.trigenlab.com
Premarket Notification
TL-CERMIDE SKIN EMULSION- BUR, SURGICAL, GENERAL & PLASTIC SURGERY EMULSION TRIGEN LABORATORIES, INC. ---------- TL-CERMIDE DES CRIPTION TL-Cermide Skin Emulsion is a steroid-free, fragrance-free, ceramide-dominant formulation. INDICATIONS FOR USE TL-Cermide Skin Emulsion is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatitis, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. TL-Cermide Skin Emulsion helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. CONTRAINDICATIONS TL-Cermide Skin Emulsion is contraindicated in persons with known hypersensitivity to any of the components of the formulation. WARNINGS TL-Cermide Skin Emulsion does not contain a sunscreen and should always be used in conjunction with a sunscreen in sun exposed areas. In radiation dermatitis and/or in conjunction with ongoing radiation therapy, apply following radiation therapy. Apply twice daily or as indicated by the radiation therapist. After application, a temporary tingling sensation may occur (10 to 15 minutes). Keep this and similar products out of the reach of children. Follow directions for use. If condition does not improve within 10 to 14 days, consult a physician. PRECAUTIONS AND OBSERVATIONS For the treatment of any dermal wound, consult a physician. Use TL-Cermide Skin Emulsion only as directed. TL-Cermide Skin Emulsion is non-toxic; however, it is for external use only and should not be ingested or taken internally If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of TL-Cermide Skin Emulsion may be continued during the anti-infective therapy If the condition does not improve within 10 to 14 days, consult a physician TL-Cermide Skin Emulsion does not contain a sunscreen and should always be used in conjunction with a sunscreen in sun exposed areas In radiation dermatitis and/or in Přečtěte si celý dokument