TRAULEVIUM PAIN RELIEF DROPS

Manufacturer
Medical Technology Products, Inc.
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:18

Label at a glance#

ProductTRAULEVIUM Pain Relief Drops
Active ingredientARNICA MONTANA ROOT, ACONITUM NAPELLUS, MATRICARIA RECUTITA, ATROPA BELLADONNA, COMFREY ROOT, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, CALCIUM SULFIDE, MERCURIUS SOLUBILIS
Label structure8 sections

Indications and uses

Uses** For the temporary relief of: Joint Pain Back Pain Muscular Pain

Dosage and administration

 Adults and children 12 years & older 30 drops per day, taking 10 drops every 4 to 6 hours.   Children under 12 years Consult your healthcare provider.   If used in children below 18 years for more than 14 days, contact a healthcare provider as these drops contain alcohol.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (HPUS*)

Each 100ml contains: Arnica Rad 3X 10ml, Aconitum Nap 3X 5ml, Chamomilla 3X 5ml, Belladonna 4X 5ml, Symphytum 8X 5ml, Bellis 2X 2ml, Calendula 2X 2ml, Echinacea 2X 2ml, Echinacea Purp 2X 2ml, Hamamelis 2X 2ml, Hypericum 3X 2ml, Millefolium 3X 2ml, Hepar Sulph Calc 8X 2ml, Merc Solub 8X 2ml.

Purpose** Relieves joint pain, back pain, muscular pain.

USES

INDICATIONS & USAGE SECTION

Uses**

For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain

WARNINGS

WARNINGS SECTION

Warnings

  • If symptoms worsen or persist for more than a week, a healthcare provider should be consulted.
  • Do not use if known sensitivity to Traulevium or any of its ingredients exists.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a healthcare provider before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

 Adults and children 12 years & older30 drops per day, taking 10 drops every 4 to 6 hours. 
 Children under 12 yearsConsult your healthcare provider. 

 If used in children below 18 years for more than 14 days, contact a healthcare provider as these drops contain alcohol.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

Do not use if tamper evident neck seal is broken or missing. Store tightly closed at room temperature. Protect from light and moisture.

**These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.

*The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients

Ethanol, Purified Water

QUESTIONS

OTC - QUESTIONS SECTION

Questions?

Call 1.866.440.7703 or email info@traulevium.com

Made in the USA. Manufactured exclusively for Medical Technology Products, Inc. by OHM pharma Inc.

Medical Technology Products, Inc.

Riviera Beach, FL 33407, USA.

www.traulevium.com

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MTP

NDC 70857-003-02

Traulevium™

PAIN RELIEF DROPS

Homeopathic Medicine

Compare to Traumeel®. Traumeel is a brand name owned by Biologische Heilmittel Heel GmbH. Traulevium is not associated with the brand owner.

Oral Drops

2 fl oz (59 mL)

Alcohol 25%

2oz bottle label2oz bottle label

OTC - PURPOSE SECTION

Pain Relief Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70857-003-02TRAULEVIUMPain Relief Drops59 mL in 1 BOTTLE, DROPPERLIQUID594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70857-003TRAULEVIUM PAIN RELIEF DROPS (ARNICA RAD, ACONITUM NAP, CHAMOMILLA, BELLADONNA, SYMPHYTUM, BELLIS, CALENDULA, ECHINACEA, ECHINACEA PURP, HAMAMELIS, HYPERICUM, MILLEFOLIUM, HEPAR SULPH CALC, MERC SOLUB.) LIQUID [MEDICAL TECHNOLOGY PRODUCTS, INC.]4Current NDC, Legacy NDC, 1 package rows20211230_1f9efd2d-16e2-4c34-b62a-3745d3c53c6b.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70857-00370857-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
TRAULEVIUM Pain Relief DropsARNICA RAD, ACONITUM NAP, CHAMOMILLA, BELLADONNA, SYMPHYTUM, BELLIS, CALENDULA, ECHINACEA, ECHINACEA PURP, HAMAMELIS, HYPERICUM, MILLEFOLIUM, HEPAR SULPH CALC, MERC SOLUB.Medical Technology Products, Inc.1f9efd2d-16e2-4c34-b62a-3745d3c53c6b2021-12-29WarningsExact identifier
ndc (package): 70857-003-02
ndc (product): 70857-003
ndc11 (package): 70857000302
spl id: d44c5766-13f6-e9cf-e053-2995a90a16b5
spl set id: 1f9efd2d-16e2-4c34-b62a-3745d3c53c6b

Reported adverse events (FAERS/openFDA)#

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