44911-0446 NDC - TRAUMA PLUS GEL (CALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUM)

Drug Information

Product NDC: 44911-0446
Proprietary Name: Trauma plus Gel
Non Proprietary Name: Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum
Active Ingredient(s): 1 [hp_X]/g ARNICA MONTANA; 12 [hp_X]/g BELLIS PERENNIS; 30 [hp_X]/g CALCIUM FLUORIDE; 1 [hp_X]/g CALENDULA OFFICINALIS FLOWERING TOP; 6 [hp_X]/g COMFREY ROOT; 30 [hp_X]/g FERROSOFERRIC PHOSPHATE; 1 [hp_X]/g HYPERICUM PERFORATUM; 12 [hp_X]/g LEDUM PALUSTRE TWIG; 30 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP; 30 [hp_C]/g SODIUM SULFATE; 12 [hp_X]/g SULFURIC ACID; 30 [hp_X]/g TOXICODENDRON PUBESCENS LEAF
Administration Route(s): TOPICAL
Dosage Form(s): GEL

Labeler Information

Field Name	Field Value
Labeler Name:	Energique, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	2/8/2018

Package Information

No.	Package Code	Package Description	Billing Unit
1	44911-0446-1	57 g in 1 TUBE (44911-0446-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	44911-0446	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	Trauma plus Gel	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum	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	2/8/2018	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	Energique, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF	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	1; 12; 30; 1; 6; 30; 1; 12; 30; 30; 12; 30
ACTIVE INGRED UNIT	[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g

44911-0446 NDC - TRAUMA PLUS GEL (CALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUM)

Drug Information

Labeler Information

Package Information

NDC Record

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