Traumeel Ointment RX

Manufacturer
MediNatura Inc | Biologische Heilmittel Heel
Effective date
2021-10-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:31:35

Label at a glance#

ProductTraumeel Rx
Active ingredientACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM, COMFREY ROOT
Label structure8 sections

Indications and uses

Indications: Traumeel ointment is an analgesic/antiflammatory homeopathic drug product indicated for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.

Dosage and administration

Standard Dosage: Adults, children and infants: Apply generously to affected areas 2 to 3 times daily, or as needed. Rub gently into the skin. Traumeel ® may be applied using mild compression bandaging and/or occlusive bandaging.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

 Analgesic & Anti-inflammatory

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Indications:

Traumeel ointment is an analgesic/antiflammatory homeopathic drug product indicated for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.

WARNINGS

WARNINGS SECTION

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Standard Dosage:

Adults, children and infants: Apply generously to affected areas 2 to 3 times daily, or as needed. Rub gently into the skin. Traumeel® may be applied using mild compression bandaging and/or occlusive bandaging.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Paraffin, liquid, Cetostearyl alcohol (type A), emulsifying, Paraffin, white soft, Ethanol (96 per cent)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Traumeel Rx ointment.jpg
Traumeel Rx ointment.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50114-9482-8GM - Gram50114-9482621570ff-4232-461e-93b7-bb8f3a55895d12016-12-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50114-948250114-9482-8, 50114-9482-6, 50114-9482-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
08b99591-f7a1-42b4-a356-3bdd01a4755a21c372fc-dadb-43e4-8c1d-9ddf05e3362d2021-10-18WarningsExact identifier
spl id: 08b99591-f7a1-42b4-a356-3bdd01a4755a
spl set id: 21c372fc-dadb-43e4-8c1d-9ddf05e3362d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.