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

Energique, Inc.
Human Otc Drug
NDC 44911-0446

Trauma Plus Gel also known as Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum is a human otc drug labeled by 'Energique, Inc.'. National Drug Code (NDC) number for Trauma Plus Gel is 44911-0446. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Trauma Plus Gel drug includes Arnica Montana - 1 [hp_X]/g Bellis Perennis - 12 [hp_X]/g Calcium Fluoride - 30 [hp_X]/g Calendula Officinalis Flowering Top - 1 [hp_X]/g Comfrey Root - 6 [hp_X]/g Ferrosoferric Phosphate - 30 [hp_X]/g Hypericum Perforatum - 1 [hp_X]/g Ledum Palustre Twig - 12 [hp_X]/g Ruta Graveolens Flowering Top - 30 [hp_X]/g Sodium Sulfate - 30 [hp_C]/g and more. The currest status of Trauma Plus Gel drug is Active.

Drug Information:

Drug 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.
Proprietary Name:	Trauma Plus Gel
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:	Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Energique, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
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:	ARNICA MONTANA - 1 [hp_X]/g BELLIS PERENNIS - 12 [hp_X]/g CALCIUM FLUORIDE - 30 [hp_X]/g CALENDULA OFFICINALIS FLOWERING TOP - 1 [hp_X]/g COMFREY ROOT - 6 [hp_X]/g FERROSOFERRIC PHOSPHATE - 30 [hp_X]/g HYPERICUM PERFORATUM - 1 [hp_X]/g LEDUM PALUSTRE TWIG - 12 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP - 30 [hp_X]/g SODIUM SULFATE - 30 [hp_C]/g Load more... SULFURIC ACID - 12 [hp_X]/g TOXICODENDRON PUBESCENS LEAF - 30 [hp_X]/g
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:	08 Feb, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	09 May, 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:	Energique, 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:	O80TY208ZW 2HU33I03UY O3B55K4YKI 18E7415PXQ M9VVZ08EKQ 91GQH8I5F7 XK4IUX8MNB 877L01IZ0P N94C2U587S 0YPR65R21J Load more... O40UQP6WCF 6IO182RP7A
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
44911-0446-1	57 g in 1 TUBE (44911-0446-1)	08 Feb, 2018	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

Trauma Plus Gel

Calendula Officinalis & more..

Gel
Energique, Inc.
NDC: 44911-0446

Purpose:

Indications: for temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.** **these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration.

Product Elements:

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 calendula officinalis flowering top calendula officinalis flowering top arnica montana arnica montana hypericum perforatum hypericum perforatum comfrey root comfrey root bellis perennis bellis perennis ledum palustre twig ledum palustre twig sulfuric acid sulfuric acid calcium fluoride fluoride ion ferrosoferric phosphate ferrosoferric phosphate toxicodendron pubescens leaf toxicodendron pubescens leaf ruta graveolens flowering top ruta graveolens flowering top sodium sulfate sodium sulfate anhydrous water whey benzyl alcohol ethylhexylglycerin tocopherol carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf sodium hydroxide edetate disodium

Indications and Usage:

Warnings:

Warnings: for external use only. if an adverse reaction occurs, discontinue use. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. do not use if tamper evident seal is broken or missing. store in a cool, dry place. do not expose product to extreme temperatures.

Dosage and Administration:

Directions: apply small amount every 10 minutes for 3 doses immediately after injury, then 2 to 3 times daily. for topical use only.

Package Label Principal Display Panel:

Package label display: energique since 1987 homeopathic remedy trauma+gel net wt. 2 oz. (57 g) trauma+gel (pain)

Further Questions:

Questions: dist. by energique, inc., 201 apple blvd. woodbine, ia 51579 800.869.8078

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.