Traulevium Pain Relief Gel

Traulevium Pain Relief Gel
SPL v5
SPL
SPL Set ID 692daf7a-11e2-4f08-bdcf-1b9ac866d213
Route
TOPICAL
Published
Effective Date 2016-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (3 [hp_X]) Calendula Officinalis Flowering Top (0.45 g) Hamamelis Virginiana Root Bark/stem Bark (0.15 g) Echinacea, Unspecified (6 [hp_X]) Echinacea Purpurea (0.1 g) Matricaria Recutita (0.09 g) 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 Sodium Hydroxide Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-09-19

Description

    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      


Medication Information

Description

    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
Section 50565-1

Keep out of the reach of children.

Section 51945-4

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)

Section 55105-1

Pain Relief Gel

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.
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

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.

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
   

 

Inactive Ingredients

Inactive ingredients:

Carbopol 980, ethanol, purified water and sodium hydroxide.


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 51945-4 (51945-4)

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)

Section 55105-1 (55105-1)

Pain Relief Gel

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.
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

Other Information (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.

Active Ingredients (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
   

 

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients:

Carbopol 980, ethanol, purified water and sodium hydroxide.


Advanced Ingredient Data


Raw Label Data

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