Traulevium Pain Relief Ointment

Traulevium Pain Relief Ointment
SPL v3
SPL
SPL Set ID 797f448f-a4c7-4c7a-980d-7c3b074e6499
Route
TOPICAL
Published
Effective Date 2016-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Root (3 [hp_X]) Calendula Officinalis Flowering Top (225 mg) Hamamelis Virginiana Root Bark/stem Bark (75 mg) Echinacea, Unspecified (6 [hp_X]) Echinacea Purpurea (50 mg) Matricaria Recutita (45 mg) Comfrey Root (4 [hp_X]) Bellis Perennis (1 [hp_X]) Hypericum Perforatum Achillea Millefolium Aconitum Napellus Atropa Belladonna Mercurius Solubilis Calcium Sulfide
Inactive Ingredients
Water Alcohol Petrolatum Paraffin Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-10-12
Description

    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      

Medication Information

Description

    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
Section 50565-1

Keep out of the reach of children.

Section 55105-1

Pain Relief Ointment

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.
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.

 

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)

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.

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
   

 

Inactive Ingredients

Inactive ingredients:

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

Structured Label Content

Uses (USES)

Uses** For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain
Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 55105-1 (55105-1)

Pain Relief Ointment

Warnings (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.
Directions (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.

 

Questions? (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 (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)

Other Information (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.

Active Ingredients (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
   

 

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients:

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:05.000179 · Updated: 2026-03-14T23:15:16.706940