to explode [0.05:/=1% of the patients in clinical studies comparing Evoclin and its vehicle is presented below: Selected Adverse Events Occurring in >/=1% of Subjects Adverse Event Number (%) of Subjects Evoclin Foam N = 439 Vehicle Foam N = 154 Headache 12 (3%) 1 (1%) Application site burning 27 (6%) 14 (9%) Application site pruritus 5 (1%) 5 (3%) Application site dryness 4 (1%) 5 (3%) Application site reaction, not otherwise specified 3 (1%) 4 (3%) In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to Evoclin. Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally. Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS ). Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin. Overdosage Topically applied Evoclin may be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ). Dosage and Administration Apply Evoclin once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Use enough to cover the entire affected area. To Use Evoclin: 1. Do not dispense Evoclin directly onto your hands or face, because the foam will begin to melt on contact with warm skin. 2. Remove the clear cap. Align the black mark with the nozzle of the actuator. 3. Hold the can at an upright angle and then press firmly to dispense. Dispense an amount directly into the cap or onto a cool surface. Dispense an amount of Evoclin that will cover the affected area(s). If the can seems warm or the foam seems runny, run the can under cold water. 4. Pick up small amounts of Evoclin with your fingertips and gently massage into the affected areas until the foam disappears. Throw away any of the unused medicine that you dispensed out of the can. Avoid contact of Evoclin with eyes. If contact occurs, rinse eyes thoroughly with water. How Supplied Evoclin containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following sizes: 100 gram can - NDC 63032-061-00 and 50 gram can - NDC 63032-061-50 STORAGE AND HANDLING Store at controlled room temperature 20 -25 C (68 -77 F). FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120 F (49 C). Keep out of reach of children. Manufactured for Printed in USA Connetics Corporation November 2004 Palo Alto, CA 94304 USA For additional information: 1-888-500-DERM or visit www.evoclin.com AW No: AW-0317-r4 U.S. Patent Pending DELIVERED IN VersaFoam Evoclin, and the interlocking C design are trademarks, and VersaFoam and Connetics are registered trademarks of Connetics Corporation. 2004 Connetics Corporation Print this page] FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates which in retrospect
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