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

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 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

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.

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 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.

INACTIVE INGREDIENTS

Inactive ingredients:

Carbopol 980, ethanol, purified water and sodium hydroxide.

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

PRINCIPAL DISPLAY PANEL

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)

Pain Relief Gel

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70857-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 100 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	0.45 g  in 100 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	0.45 g  in 100 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	0.15 g  in 100 g
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	0.15 g  in 100 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	0.15 g  in 100 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 100 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	0.1 g  in 100 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X]  in 100 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	0.09 g  in 100 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X]  in 100 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	1 [hp_X]  in 100 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	6 [hp_X]  in 100 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_X]  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70857-004-16	454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/19/2016

Labeler - Medical Technology Products, Inc. (150890841)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(70857-004)