FDA Label for Traumeel
View Indications, Usage & Precautions
Traumeel Product Label
The following document was submitted to the FDA by the labeler of this product Heel Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Traumeel Ear Drops Rx is a liquid homeopathic drug for otic administration. Each 0.45 ml vial contains Active Ingredients: Arnica montana, radix 3X 9.9 mcl, Belladonna 3X 9.9 mcl, Aconitum napellus 3X 9.54 mcl, Hypericum perforatum 3X 2.97 mcl, Calendula officinalis 2X 0.99 mcl, Chamomilla 3X 0.99 mcl, Millefolium 3X 0.99 mcl, Hepar sulphuris calcareum 6X 0.99 mcl, Symphytum officinale 6X 0.99 mcl, Bellis perennis 2X 0.495 mcl, Mercurius solubilis 6X 0.495 mcl, Echinacea 2X 0.247 mcl, Echinacea purpurea 2X 0.247 mcl, Hamamellis virginiana 1X 0.099 mcl Inactive Ingredients: Isotonic Sodium Chloride Solution.
Indications And Usage
Traumeel Ear Drops Rx is indicated for the treatment of pain due to inflammation of otitis media and externa.
Dosage And Administration
Adults and children 6 years and over: pour contents of 1 vial directly into the affected ear up to 3 times daily. Infants and children under 6 years: pour 1/2 of the contents of 1 vial into the affected ear up to 3 times daily.
Warnings And Precautions
No harmful or potentially harmful side effects are known. Traumeel ear drops is generally well-tolerated, however if symptoms persist or worsen, discontinue use.To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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