TRAULEVIUM- arnica montana radix, calendula officinalis, hamamelis virginiana, echinacea, echinacea purpurea, chamomilla, symphytum officinale, bellis perennis, hypericum perforatum, millefolium, aconitum napellus, belladonna, mercurius solubilis, hepar sulphuris calcareum. ointment

Traulevium by

Drug Labeling and Warnings

Traulevium by is a Homeopathic medication manufactured, distributed, or labeled by Medical Technology Products, Inc., OHM PHARMA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

• Active ingredients (HPUS*): Purpose**
• 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.

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 info@traulevium.com

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)

Pain Relief Ointment

INGREDIENTS AND APPEARANCE

TRAULEVIUM 
arnica montana radix, calendula officinalis, hamamelis virginiana, echinacea, echinacea purpurea, chamomilla, symphytum officinale, bellis perennis, hypericum perforatum, millefolium, aconitum napellus, belladonna, mercurius solubilis, hepar sulphuris calcareum. ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70857-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	3 [hp_X]  in 50 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	225 mg  in 50 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	225 mg  in 50 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	75 mg  in 50 g
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	75 mg  in 50 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	75 mg  in 50 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 50 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	50 mg  in 50 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X]  in 50 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	45 mg  in 50 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X]  in 50 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	1 [hp_X]  in 50 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	6 [hp_X]  in 50 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_X]  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70857-001-50	1 in 1 BOX	10/12/2016
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/12/2016

Labeler - Medical Technology Products, Inc. (150890841)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(70857-001)