FDA Label for Traulevium
View Indications, Usage & Precautions
Traulevium 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*) | 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 older | Apply 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 4 | Consult 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.
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.