|Labeler Name||Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC|
|Dosage & Substance||gel echinacea angustifolia; echinacea purpurea; aconitum napellus; arnica montana; calendula officinalis flowering top; hamamelis virginiana root bark/stem bark; atropa belladonna; bellis perennis; chamomile; achillea millefolium; hypericum oil; comfrey root;|
|Date First Marketed||November 11, 2011|
INDICATIONS AND USAGE
The drug is indicated for the relief of symptoms, including pain and inflammation associated with arthritis or trauma (such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic, edema, post surgical edema, hematoma, general swelling of joints and soft tissues) to areas such as hand, wrist elbow, shoulder, neck, back, knees, ankles, feet and toes.
This drug should not be used by those sensitive to Arnica or any of the other listed ingredients.
Rarely, allergic skin reactions may occur. These effects are transient and will clear after a few days.
WARNINGS AND PRECAUTIONS
For external use only. direct patient not to ingest TRANZEL and to avoid contact with they eyes, mucous membranes, wounds, and damaged skin. If a rash develops, patient should discontinue use until rash clears. After the disappearance of rash, patient can try TRANZGEL again on a test area and monitor the site for additional results. If no rash or redness results, then patient can resume use. However, if the rash persists or redevelops, use should be discontinued.
Direct the patient to keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.
In the homeopathic concentrations used to make TRANZGEL, there are no known or expected interactions with other drugs or laboratory tests. In addition, the homeopathic concentrations used are below any levels with known or suspected toxicities.
According to toxicology studies, a patient would have to orally ingest a minimum of 22 bottles of TRANZGEL to experience any initial toxic effects.
A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations.