TRAULEVIUM PAIN RELIEF DROPS- arnica rad, aconitum nap, chamomilla, belladonna, symphytum, bellis, calendula, echinacea, echinacea purp, hamamelis, hypericum, millefolium, hepar sulph calc, merc solub. liquid

TRAULEVIUM by

Drug Labeling and Warnings

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

Drug Details [pdf]

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.

USES

Uses**

For the temporary relief of:

• Joint Pain
• Back Pain
• Muscular Pain

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.

keep out of reach of children

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

QUESTIONS

Questions?

Call 1.866.440.7703 or email 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 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%

Pain Relief Drops

INGREDIENTS AND APPEARANCE

TRAULEVIUM  PAIN RELIEF DROPS
arnica rad, aconitum nap, chamomilla, belladonna, symphytum, bellis, calendula, echinacea, echinacea purp, hamamelis, hypericum, millefolium, hepar sulph calc, merc solub. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70857-003
Route of Administration	ORAL

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 59 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]  in 59 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	4 [hp_X]  in 59 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	8 [hp_X]  in 59 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	2 [hp_X]  in 59 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	2 [hp_X]  in 59 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	2 [hp_X]  in 59 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	2 [hp_X]  in 59 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	2 [hp_X]  in 59 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X]  in 59 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	3 [hp_X]  in 59 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	8 [hp_X]  in 59 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	8 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70857-003-02	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/11/2016

Labeler - Medical Technology Products, Inc. (150890841)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(70857-003)