ActivaPatch Buffered Electronic Iontophoresis Drug Delivery System

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Contraindications (Iontophoresis is contraindicated for patients with):

• Cardiac pacemakers or other electrically-sensitive implanted devices
• Known sensitivity to the ionic solutions to be administered
• Known adverse reactions to the application of electrical current

Warning and Precautions:

• Do not use an ActivaPatch that appears to have been altered or damaged in any way
• Do not use on damaged skin or recent scar tissue
• Do not use across the temporal regions or for the treatment of the orbital region
• Only use with negatively-charged solutions 
• The ActivaPatch can be worn during normal activity, however, excessive motion where the ActivaPatch has been placed can cause poor contact between the skin and the electrodes
• This may result in uneven distribution of current, increasing the risk of skin irritation
• Do not shave the application site area
• If necessary, clip the hair
• Before giving an iontophoretic treatment, the patient should be advised of the potential for skin irritation or burns
• An area of transient erythema, characterized by a uniform red pattern, can occur under the ground and active electrodes
• The redness should resolve within a few hours
• Advise the patient to remove the ActivaPatch and immediately report any burning sensation or discomfort
• Do not allow any metals to come in contact with any of the electrodes
• Advise patient to remove all jewelry and metallic piercings around the treatment site
• Discard immediately after each treatment
• Do not get electrodes wet, as this may cause the electrode to short

Specification

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