Traumeel
FDA Label NDC 50114-7110

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Heel Inc for the product Traumeel (NDC 50114-7110). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, dosage and administration, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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