Traumeel Ointment

Manufacturer
MediNatura Inc | Biologische Heilmittel Heel
Effective date
2023-09-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:22:21

Label at a glance#

ProductTraumeel
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

Dosage and administration

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.

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

Warning

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.
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.
Store at room temperature. Protect from light.
Please retain outer carton for full product instructions.
WARNING: This product can expose you to mercury, which is known to
the State of California to cause birth defects or other reproductive harm.
For more information go to www.P65Warnings.ca.gov.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Indications

INDICATIONS & USAGE SECTION

For the temporary relief of muscular pain from sports injuries, bruising.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Traumeel OintmentTraumeel Ointment

Add image transcription here...

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-9487-8Traumeel1 in 1 CARTONOINTMENT13
62795-9487-8Traumeel100 g in 1 TUBEOINTMENT1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-9487TRAUMEEL (ACONITUM 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 AND COMFREY ROOT) OINTMENT [MEDINATURA INC]3Current NDC, Legacy NDC, 2 package rows20230927_c9962e63-3c30-4c62-9caf-91f663c7eeaa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-9487-8GM - Gram62795-94870961366e-d444-4d0a-99b1-50a284f97a4412022-05-04

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-948762795-9487-8

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

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
TraumeelACONITUM 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 AND COMFREY ROOTMediNatura Incc9962e63-3c30-4c62-9caf-91f663c7eeaa2023-09-26WarningsExact identifier
ndc (package): 62795-9487-8
ndc (product): 62795-9487
ndc11 (package): 62795948708
spl id: f3bcc288-eae8-4ad0-b3f2-b0d170d3cf21
spl set id: c9962e63-3c30-4c62-9caf-91f663c7eeaa

Reported adverse events (FAERS/openFDA)#

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