The following Structured Product Label (SPL) was submitted to the FDA by Medinatura Inc for the product Traumeel (NDC 62795-9487). 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 active ingredients, purpose, warning, directions, inactive ingredients, keep out of reach of children, indications, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients: Each 100 g contains:
*Aconitum napellus 1X 0.050g; *Arnica montana, radix 3X 1.50g; *Belladonna 1X 0.050g; *Bellis perennis MT 0.100g; *Calendula officinalis MT 0.450g; *Chamomilla MT 0.150g; *Echinacea MT 0.150g; *Echinacea purpurea MT 0.150g; *Hamamelis virginiana MT 0.450g; Hepar sulphuris calcareum 6X 0.025g; *Hypericum perforatum 6X 0.090g; Mercurius solubilis 6X 0.040g; *Millefolium MT 0.090g; *Symphytum officinale 4X 0.100g.
*Natural Ingredients
Analgesic
Warnings: For external use only. Cetylstearyl alcohol may cause local skin reactions, i.e.
contact dermatitis. Do not apply over large areas of the body. Do not apply over open wounds or
broken skin. If symptoms persist or worsen, or if a rash develops, a physician should be consulted.
Do not use if known sensitivity to Traumeel® ointment or any of its ingredients exists. Keep out of
reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.
Directions: Adults and children 4 years and older: Apply generously to affected areas 2 to 3 times daily, or as directed
by your health professional. Massage thoroughly into skin. Traumeel® may be applied using mild compression bandaging
and/or occlusive bandaging. For children under 4, use as directed by your health professional.
Inactive ingredients:
Paraffin, liquid, Cetostearyl alcohol (type A), emulsifying, Paraffin, white soft, Ethanol (96 per cent)
KEEP OUT OF REACH OF CHILDREN
For the temporary relief of muscular pain from sports injuries, bruising.
* Please review the disclaimer below.
