Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Trigen Laboratories, LLC
TOPICAL
AVO CreamTM Topical Emulsion is indicated for use in: - Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers - Superficial Wounds - 1st and 2nd Degree Burns, including Sunburns - Dermal Donor and Graft Site Management - Radiation Dermatitis - Minor Abrasions AVO CreamTM Topical Emulsion is contraindicated for use on bleeding wounds, skin rashes related to food or medicine allergies, and when an allergy to one of the ingredients is known. AVO CreamTM Topical Emulsion is for topical use only as directed by a healthcare professional. Wounds, Abrasions, Full Thickness Wounds, Dermal Graft Site Management and Donor Site Management. - Wash the affected area(s) with saline, clean water, or a suitable wound cleanser. - Apply AVO CreamTM Topical Emulsion on and around the affected area(s) in thick layers 1/4 to 1/2 inch thick. - If applying gauze dressing, moisten the dressing lightly before application. - Reapply AVO CreamTM Topical Emulsion as described above every 24 to 48 hours or as
AVO CreamTM Topical Emulsion is supplied in a: 45 gram tube Product Code: 13811-565-45 90 gram tube Product Code: 13811-565-90 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, LLC Sayreville, NJ 08872 www.trigenlab.com Rev. 01/15
Premarket Notification
AVO CREAM- BUR, SURGICAL, GENERAL & PLASTIC SURGERY EMULSION TRIGEN LABORATORIES, LLC ---------- AVO CREAM TOPICAL EMULSION DESCRIPTION AVO Cream Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream Topical Emulsion provides an optimum moist environment for the healing process and provides temporary wound protection from harmful germs and other external contamination. INDICATIONS FOR USE AVO Cream Topical Emulsion is indicated for use in: Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers Superficial Wounds 1st and 2nd Degree Burns, including Sunburns Dermal Donor and Graft Site Management Radiation Dermatitis Minor Abrasions CONTRAINDICATIONS AVO Cream Topical Emulsion is contraindicated for use on bleeding wounds, skin rashes related to food or medicine allergies, and when an allergy to one of the ingredients is known. WARNINGS In radiation therapy, AVO Cream Topical Emulsion may be applied as directed by the treating physician. Do not apply 4 hours prior to a radiation session. Do not apply AVO Cream Topical Emulsion to dermal grafts until after the graft has successfully taken. Keep out of the reach of children. PRECAUTIONS AND OBSERVATIONS For the treatment of any dermal wound, consult a physician. Use AVO Cream Topical Emulsion only as directed. AVO Cream Topical Emulsion is non-toxic. It is for topical use only and should not be ingested or taken internally. AVO Cream Topical Emulsion does not contain a sunscreen and should not be used prior to extended exposure to the sun. The use of AVO Cream Topical Emulsion on skin rashes due to allergies has not been studied sufficiently and therefore is not recommended. Following the application of AVO Cream Topical Emulsion a temporary tingling sensation may occur (10 to 15 minutes). If clinical signs of infection are presen Les hele dokumentet