FDA.reportPublic FDA data

Traumex

Manufacturer
MediNatura Inc
Effective date
2023-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:20:34

Label at a glance#

ProductTraumex
Active ingredientARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE, ACONITUM NAPELLUS WHOLE, MATRICARIA CHAMOMILLA WHOLE, ACHILLEA MILLEFOLIUM WHOLE, ATROPA BELLADONNA, HYPERICUM PERFORATUM WHOLE, RUTA GRAVEOLENS FLOWERING TOP, COMFREY ROOT
Label structure8 sections

Indications and uses

 For the temporary relief of minor symptoms of bruising and pain.

Dosage and administration

 At first sign of symptoms: Adults and children 4 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Standard dosage: Adults and children 4 years and older: 3 tablets per day, taking 1 tablet every 4-6 hours. Do not exceed 12 tablets in 24 hours. For children under 4 years, consult your health professional. Allow tablets to dissolve completely in the mouth, do ...

Label contents#

Full prescribing information#

Uses:

INDICATIONS & USAGE SECTION

 For the temporary relief of minor symptoms of bruising
and pain.

Warnings:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health
professional before use. Keep out of reach of children.
If symptoms persist or worsen, a health professional
should be consulted. Do not use if known sensitivity to
BHI Traumex® or any of its ingredients exists.–

Directions:

DOSAGE & ADMINISTRATION SECTION

 At first sign of symptoms: Adults and children 4 years
and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then
continue with standard dosage. Standard dosage: Adults and
children 4 years and older: 3 tablets per day, taking 1 tablet every
4-6 hours. Do not exceed 12 tablets in 24 hours. For children
under 4 years, consult your health professional. Allow tablets to
dissolve completely in the mouth, do not swallow

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

 Dextrose, Magnesium
stearate, Maltodextrin

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Purpose

OTC - PURPOSE SECTION

Pain Relief

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

 Each tablet contains: *Arnica
montana 3X 150mg, *Calendula officinalis 2X 10mg,
*Hamamelis virginiana 2X 10mg, *Baptisia tinctoria
2X 6mg, *Bellis perennis 2X 6mg, *Echinacea 2X 6mg,
*Aconitum napellus 3X 30mg, *Chamomilla 2X 3mg,
*Millefolium 2X 2mg, *Belladonna 3X 8mg, *Hypericum
perforatum 3X 8mg, *Ruta graveolens 4X 10mg,
*Arnica montana 6X 21mg, *Symphytum officinale 8X
24mg, *Arnica montana 10X 6mg. *Natural

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TraumexTraumex

Add image transcription here...

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-2302-2Traumex60 in 1 BOTTLETABLET, CHEWABLE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-2302TRAUMEX (ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT) TABLET, CHEWABLE [MEDINATURA INC]1Current NDC, 1 package rows20230322_335c8bec-f0c3-4b95-a6a6-5fda262be0e6.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-230262795-2302-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA WHOLEO80TY208ZWACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BELLIS PERENNIS WHOLE2HU33I03UYACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
COMFREY ROOTM9VVZ08EKQACTIB
DextroseIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
Maltodextrin7CVR7L4A2DIACT

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
TraumexARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc335c8bec-f0c3-4b95-a6a6-5fda262be0e62023-03-20WarningsExact identifier
ndc (package): 62795-2302-2
ndc (product): 62795-2302
ndc11 (package): 62795230202
spl id: b8047305-bf5e-40a9-98b7-cc113890003b
spl set id: 335c8bec-f0c3-4b95-a6a6-5fda262be0e6

Reported adverse events (FAERS/openFDA)#

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