Traulevium Ointment
FDA Label NDC 70857-001

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 70857-001). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, questions?, 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*) Purpose**
 Each 50 g of ointment contains: 
 Arnica Montana, Radix 3X 750 mg Reduces joint & back pain
 Calendula Officinalis MT (N) 225 mg Relieves pain
 Hamamelis Virginiana MT (N) 225 mg Relieves joint & muscle soreness 
 Echinacea MT (N) 75 mg Relieves pain
 Echinacea Purpurea MT (N) 75 mg Relieves pain 
 Chamomilla MT (N) 75 mg Soothing pain relief 
 Symphytum Officinale 4X (Final concentration 6X) 50 mg Relieves joint pain 
 Bellis Perennis MT (M) 50 mg Relieves joint & muscle soreness 
 Hypericum Perforatum 6X 45 mg Relieves pain 
 Millefolium MT (N) 45 mg Relieves pain 
 Aconitum Napellus 1X (Final concentration 4X) 25 mg Reduces joint & back pain 
 Belladonna 1X 25 mg Reduces back pain 
 Mercurius Solubilis 6X 20 mg Reduces joint & back pain 
 Hepar Sulphuris Calcareum 6X 12.5 mg Relieves pain
  

 

Uses

Uses** For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain

Warnings

Warnings

For external use only.

  • Do not apply over open wounds or broken skin.
  • If symptoms worsen or persist for more than a week, or if a rash develops, a healthcare provider should be consulted.
  • In rare cases, allergic skin reactions may develop.
  • Do not use if known sensitivity to Traulevium 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, consult a healthcare provider before use.
  • Contraindications: Known allergy (hypersensitivity) to one of the ingredients, including plants of the daisy family (Asteraceae) such as Arnica montana (arnica), Calendula officinalis (pot marigold), Chamomilla (German chamomile), Echinacea (coneflower), Achillea millefolium (yarrow), Bellis perennis (daisy) and emulsifying cetylstearyl alcohol.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Directions

 
Adults and children 4 years and olderApply generously to affected areas 2 to 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. 
Children under 4Consult your healthcare provider.

 

Other Information

Other information

Tamper evident: Do not use if protective seal under cap is broken. Store at room temperature. Protect from light. Please retain outer carton for full product instructions.

**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:

Cetylstearyl alcohol, ethanol, paraffin, purified water and white petrolatum.

Questions?

Questions?

Call 1.866.440.7703 or e-mail [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 Labeling

NDC 70857-001-50

Traulevium™

Pain Relief Ointment

Homeopathic Medicine

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

Net Wt. 1.76 oz (50 g)

Otc - Purpose

Pain Relief Ointment

* Please review the disclaimer below.