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.

Medical Technology Products, Inc.
Human Otc Drug
NDC 70857-001

Traulevium also known as 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. is a human otc drug labeled by 'Medical Technology Products, Inc.'. National Drug Code (NDC) number for Traulevium is 70857-001. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Traulevium drug includes Achillea Millefolium - 45 mg/50g Aconitum Napellus - 4 [hp_X]/50g Arnica Montana Root - 3 [hp_X]/50g Atropa Belladonna - 1 [hp_X]/50g Bellis Perennis - 50 mg/50g Calcium Sulfide - 6 [hp_X]/50g Calendula Officinalis Flowering Top - 225 mg/50g Comfrey Root - 6 [hp_X]/50g Echinacea Purpurea - 75 mg/50g Echinacea, Unspecified - 75 mg/50g and more. The currest status of Traulevium drug is Active.

Drug Information:

Drug NDC:	70857-001
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Traulevium
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	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.
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Medical Technology Products, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACHILLEA MILLEFOLIUM - 45 mg/50g ACONITUM NAPELLUS - 4 [hp_X]/50g ARNICA MONTANA ROOT - 3 [hp_X]/50g ATROPA BELLADONNA - 1 [hp_X]/50g BELLIS PERENNIS - 50 mg/50g CALCIUM SULFIDE - 6 [hp_X]/50g CALENDULA OFFICINALIS FLOWERING TOP - 225 mg/50g COMFREY ROOT - 6 [hp_X]/50g ECHINACEA PURPUREA - 75 mg/50g ECHINACEA, UNSPECIFIED - 75 mg/50g Load more... HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 225 mg/50g HYPERICUM PERFORATUM - 6 [hp_X]/50g MATRICARIA RECUTITA - 75 mg/50g MERCURIUS SOLUBILIS - 6 [hp_X]/50g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	12 Oct, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Medical Technology Products, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	2FXJ6SW4PK U0NQ8555JD MUE8Y11327 WQZ3G9PF0H 2HU33I03UY 1MBW07J51Q 18E7415PXQ M9VVZ08EKQ QI7G114Y98 4N9P6CC1DX Load more... T7S323PKJS XK4IUX8MNB G0R4UBI2ZZ 324Y4038G2
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
70857-001-50	1 TUBE in 1 BOX (70857-001-50) / 50 g in 1 TUBE	12 Oct, 2016	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Traulevium

Arnica Montana Radix & more..

Ointment
Medical Technology Products, Inc.
NDC: 70857-001

Purpose:

Pain relief ointment

Product Elements:

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. water alcohol petrolatum paraffin cetostearyl alcohol arnica montana root arnica montana root calendula officinalis flowering top calendula officinalis flowering top hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark echinacea, unspecified echinacea, unspecified echinacea purpurea echinacea purpurea matricaria recutita matricaria recutita comfrey root comfrey root bellis perennis bellis perennis hypericum perforatum hypericum perforatum achillea millefolium achillea millefolium aconitum napellus aconitum napellus atropa belladonna atropa belladonna mercurius solubilis mercurius solubilis calcium sulfide calcium sulfide

Indications and Usage:

Uses uses** for the temporary relief of: joint pain back pain muscular pain

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. 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.

Dosage and Administration:

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.

Package Label Principal Display Panel:

Package labeling ndc 70857-001-50 traulevium â¢ pain relief ointment homeopathic medicine compare to traumeelÂ®. 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) tube box pain relief ointment

Further Questions:

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

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.