| Document Date: 2009-03-31 15:48:59
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City Paul / / Company Empi Inc. / NH CO / Ames / / Event FDA Phase / Product Issues / / IndustryTerm repeat applications / sterile nonpyrogenic solution / similar products / local anesthetic solutions / implanted devices / intended treatment site / / MedicalCondition Bruise / severe coronary artery disease / double vision / tremors / severe hepatic disease / headache / liver dysfunction / seizures / unconsciousness / hives / cerebral hemorrhage / nausea / tremor / numbness / drowsiness / injury / pulmonary edema / bradycardia / burns / tachycardia / hypersensitivity / cardiac arrest / Renal dysfunction / hepatic disease / hypotension / light-headedness / hypertensive vascular disease / peripheral vascular disease / hypertension / bronchospasm / petechiae / dyspnea / skin abnormalities / shock / Carcinogenesis / cardiac arrhythmias / severe prolonged hypertension / skin irritation / erythema / itching / hypesthesia / vomiting / pain / severe eye irritation / local skin irritation / concomitant disease / urticaria / angioedema / Allergic Reactions / telangiectases / respiratory depression / irritation / dizziness / Inflammation / paresthesia / tinnitus / local tissue injury / / MedicalTreatment drug therapy / Dialysis / / Organization FDA / / Position Dupel Iontophoretic Controller / Precautions General / / Product sodium chloride / lidocaine hydrochloride and epinephrine / Epinephrine / Lidocaine / Lidocaine Hydrochloride / NOT FOR INJECTION / polysporin / for / 2H5 / cardiovascular function / renal function / / ProvinceOrState South Dakota / / Technology Geriatrics / Pharmacokinetics / PHARMACODYNAMICS / Dialysis / /
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FDA Labeling – Approval October 26, 2004 Page 1 of 14 Tradename (Lidocaine HCl 2% and Epinephrine 1:100,000 Solution for Topical Iontophoretic System) Clinical Pharmacology