Traulevium Liquid
FDA Label NDC 70857-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medical Technology Products, Inc. for the product Traulevium (NDC 70857-003). 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, uses, warnings, directions, other information, inactive ingredients, questions, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

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

Uses**

For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain

Warnings

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.

Directions

 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 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 ingredients

Ethanol, Purified Water

Questions

Questions?

Call 1.866.440.7703 or email [email protected]

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

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%

Otc - Purpose

Pain Relief Drops

* Please review the disclaimer below.