70857-004 NDC - TRAULEVIUM (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.)

Drug Information

Product NDC: 70857-004
Proprietary Name: Traulevium
Non Proprietary Name: 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.
Active Ingredient(s): .09 g/100g ACHILLEA MILLEFOLIUM; 4 [hp_X]/100g ACONITUM NAPELLUS; 3 [hp_X]/100g ARNICA MONTANA; 1 [hp_X]/100g ATROPA BELLADONNA; .1 g/100g BELLIS PERENNIS; 6 [hp_X]/100g CALCIUM SULFIDE; .45 g/100g CALENDULA OFFICINALIS FLOWERING TOP; 6 [hp_X]/100g COMFREY ROOT; .15 g/100g ECHINACEA PURPUREA; .15 g/100g ECHINACEA, UNSPECIFIED; .45 g/100g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; 6 [hp_X]/100g HYPERICUM PERFORATUM; .15 g/100g MATRICARIA RECUTITA; 6 [hp_X]/100g MERCURIUS SOLUBILIS
Administration Route(s): TOPICAL
Dosage Form(s): GEL

Labeler Information

Field Name	Field Value
Labeler Name:	Medical Technology Products, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	9/19/2016

Package Information

No.	Package Code	Package Description	Billing Unit
1	70857-004-16	454 g in 1 BOTTLE, PUMP (70857-004-16)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	70857-004	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.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Traulevium	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX	Pain Relief Gel	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAME	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.	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	GEL	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	TOPICAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	9/19/2016	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product types are broken down into several potential Marketing Categories, such as NDA/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.
LABELER NAME	Medical Technology Products, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	.09; 4; 3; 1; .1; 6; .45; 6; .15; .15; .45; 6; .15; 6
ACTIVE INGRED UNIT	g/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; g/100g; [hp_X]/100g; g/100g; [hp_X]/100g; g/100g; g/100g; g/100g; [hp_X]/100g; g/100g; [hp_X]/100g

70857-004 NDC - TRAULEVIUM (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.)

Drug Information

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