FDA Label for Traulevium Pain Relief Gel
View Indications, Usage & Precautions
Traulevium Pain Relief Gel 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 100 g of gel contains: | |
| Arnica Montana, Radix 3X 1500 mg | Reduces joint & back pain |
| Calendula Officinalis MT (N) 450 mg | Relieves pain |
| Hamamelis Virginiana MT (N) 450 mg | Relieves joint & muscle soreness |
| Echinacea MT (N) 150 mg | Relieves pain |
| Echinacea Purpurea MT (N) 150 mg | Relieves pain |
| Chamomilla MT (N) 150 mg | Soothing pain relief |
| Symphytum Officinale 4X (Final concentration 6X) 100 mg | Relieves joint pain |
| Bellis Perennis MT (M) 100 mg | Relieves joint & muscle soreness |
| Hypericum Perforatum 6X 90 mg | Relieves pain |
| Millefolium MT (N) 90 mg | Relieves pain |
| Aconitum Napellus 1X (Final concentration 4X) 50 mg | Reduces joint & back pain |
| Belladonna 1X 50 mg | Reduces back pain |
| Mercurius Solubilis 6X 40 mg | Reduces joint & back pain |
| Hepar Sulphuris Calcareum 6X 25 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.
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 around the pump is broken or missing. Store at room temperature. Protect from light.
**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:
Carbopol 980, ethanol, purified water and sodium hydroxide.
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 Label.Principal Display Panel
NDC 70857-004-16
Traulevium™
Pain Relief Gel
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. 16oz (454 g)
Otc - Purpose
Pain Relief Gel
* Please review the disclaimer below.