FDA Label for Traulevium Pain Relief Drops

View Indications, Usage & Precautions

Traulevium Pain Relief Drops Product Label

The following document was submitted to the FDA by the labeler of this product Medical Technology Products, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.