traulevium pain relief drops

traulevium pain relief drops
SPL v4
SPL
SPL Set ID 1f9efd2d-16e2-4c34-b62a-3745d3c53c6b
Route
oral
Published
Effective Date 2019-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
arnica montana root (3 [hp_X]) aconitum napellus (4 [hp_X]) matricaria recutita (8 [hp_X]) atropa belladonna (2 [hp_X]) comfrey root bellis perennis calendula officinalis flowering top echinacea angustifolia echinacea purpurea hamamelis virginiana root bark/stem bark hypericum perforatum achillea millefolium calcium sulfide mercurius solubilis
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2016-10-11

Description

Active ingredients (HPUS*) Each 100ml contains: Arnica Rad 3X 10ml, Aconitum Nap 3X 5ml, Chamomilla 3X 5ml, Belladonna 4X 5ml, Symphytum 8X 5ml, Bellis 2X 2ml, Calendula 2X 2ml, Echinacea 2X 2ml, Echinacea Purp 2X 2ml, Hamamelis 2X 2ml, Hypericum 3X 2ml, Millefolium 3X 2ml, Hepar Sulph Calc 8X 2ml, Merc Solub 8X 2ml. Purpose** Relieves joint pain, back pain, muscular pain.


Medication Information

Warnings

Warnings

  • If symptoms worsen or persist for more than a week, a healthcare provider should be consulted.
  • Do not use if known sensitivity to Traulevium or any of its ingredients exists.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a healthcare provider before use.
Uses

Uses**

For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain
Directions
 Adults and children 12 years & older 30 drops per day, taking 10 drops every 4 to 6 hours. 
 Children under 12 years Consult your healthcare provider. 

 If used in children below 18 years for more than 14 days, contact a healthcare provider as these drops contain alcohol.

Other Information

Other information

Do not use if tamper evident neck seal is broken or missing. Store tightly closed at room temperature. Protect from light and moisture.

**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

Ethanol, Purified Water

Description

Active ingredients (HPUS*) Each 100ml contains: Arnica Rad 3X 10ml, Aconitum Nap 3X 5ml, Chamomilla 3X 5ml, Belladonna 4X 5ml, Symphytum 8X 5ml, Bellis 2X 2ml, Calendula 2X 2ml, Echinacea 2X 2ml, Echinacea Purp 2X 2ml, Hamamelis 2X 2ml, Hypericum 3X 2ml, Millefolium 3X 2ml, Hepar Sulph Calc 8X 2ml, Merc Solub 8X 2ml. Purpose** Relieves joint pain, back pain, muscular pain.

Section 50565-1

keep out of reach of children

Section 55105-1

Pain Relief Drops

Questions

Questions?

Call 1.866.440.7703 or email [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 Label

MTP

NDC 70857-003-02

Traulevium™

PAIN RELIEF DROPS

Homeopathic Medicine

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

Oral Drops

2 fl oz (59 mL)

Alcohol 25%

Active Ingredients

Active ingredients (HPUS*)

Each 100ml contains: Arnica Rad 3X 10ml, Aconitum Nap 3X 5ml, Chamomilla 3X 5ml, Belladonna 4X 5ml, Symphytum 8X 5ml, Bellis 2X 2ml, Calendula 2X 2ml, Echinacea 2X 2ml, Echinacea Purp 2X 2ml, Hamamelis 2X 2ml, Hypericum 3X 2ml, Millefolium 3X 2ml, Hepar Sulph Calc 8X 2ml, Merc Solub 8X 2ml.

Purpose** Relieves joint pain, back pain, muscular pain.


Structured Label Content

Warnings (WARNINGS)

Warnings

  • If symptoms worsen or persist for more than a week, a healthcare provider should be consulted.
  • Do not use if known sensitivity to Traulevium or any of its ingredients exists.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a healthcare provider before use.
Uses (USES)

Uses**

For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain
Directions (DIRECTIONS)
 Adults and children 12 years & older 30 drops per day, taking 10 drops every 4 to 6 hours. 
 Children under 12 years Consult your healthcare provider. 

 If used in children below 18 years for more than 14 days, contact a healthcare provider as these drops contain alcohol.

Other Information (OTHER INFORMATION)

Other information

Do not use if tamper evident neck seal is broken or missing. Store tightly closed at room temperature. Protect from light and moisture.

**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)

Inactive ingredients

Ethanol, Purified Water

Section 50565-1 (50565-1)

keep out of reach of children

Section 55105-1 (55105-1)

Pain Relief Drops

Questions (QUESTIONS)

Questions?

Call 1.866.440.7703 or email [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 Label (PACKAGE LABEL)

MTP

NDC 70857-003-02

Traulevium™

PAIN RELIEF DROPS

Homeopathic Medicine

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

Oral Drops

2 fl oz (59 mL)

Alcohol 25%

Active Ingredients (ACTIVE INGREDIENTS)

Active ingredients (HPUS*)

Each 100ml contains: Arnica Rad 3X 10ml, Aconitum Nap 3X 5ml, Chamomilla 3X 5ml, Belladonna 4X 5ml, Symphytum 8X 5ml, Bellis 2X 2ml, Calendula 2X 2ml, Echinacea 2X 2ml, Echinacea Purp 2X 2ml, Hamamelis 2X 2ml, Hypericum 3X 2ml, Millefolium 3X 2ml, Hepar Sulph Calc 8X 2ml, Merc Solub 8X 2ml.

Purpose** Relieves joint pain, back pain, muscular pain.


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