Hevert Trauma Roll-on

Arnica Montana Root, Bellis Perennis, Calendula Officinalis Flowering Top, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium Flowering Top, Ruta Graveolens Flowering Top, And Comfrey Root

Hevert Arzneimittel Gmbh & Co Kg
Human Otc Drug
NDC 54532-0024

Hevert Trauma Roll-on also known as Arnica Montana Root, Bellis Perennis, Calendula Officinalis Flowering Top, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium Flowering Top, Ruta Graveolens Flowering Top, And Comfrey Root is a human otc drug labeled by 'Hevert Arzneimittel Gmbh & Co Kg'. National Drug Code (NDC) number for Hevert Trauma Roll-on is 54532-0024. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Hevert Trauma Roll-on drug includes Achillea Millefolium Flowering Top - 1 [hp_X]/mL Arnica Montana Root - 3 [hp_X]/mL Bellis Perennis Whole - 1 [hp_X]/mL Calendula Officinalis Flowering Top - 1 [hp_X]/mL Comfrey Root - 6 [hp_X]/mL Hamamelis Virginiana Root Bark/stem Bark - 1 [hp_X]/mL Hypericum Perforatum Whole - 6 [hp_X]/mL Ruta Graveolens Flowering Top - 4 [hp_X]/mL . The currest status of Hevert Trauma Roll-on drug is Active.

Drug Information:

Drug NDC:	54532-0024
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:	Hevert Trauma Roll-on
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 Root, Bellis Perennis, Calendula Officinalis Flowering Top, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium Flowering Top, Ruta Graveolens Flowering Top, And Comfrey Root
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hevert Arzneimittel Gmbh & Co Kg
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:	ACHILLEA MILLEFOLIUM FLOWERING TOP - 1 [hp_X]/mL ARNICA MONTANA ROOT - 3 [hp_X]/mL BELLIS PERENNIS WHOLE - 1 [hp_X]/mL CALENDULA OFFICINALIS FLOWERING TOP - 1 [hp_X]/mL COMFREY ROOT - 6 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 1 [hp_X]/mL HYPERICUM PERFORATUM WHOLE - 6 [hp_X]/mL RUTA GRAVEOLENS FLOWERING TOP - 4 [hp_X]/mL
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:	01 Apr, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 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:	Hevert Arzneimittel GmbH & Co KG
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:	55862Q3XEU MUE8Y11327 2HU33I03UY 18E7415PXQ M9VVZ08EKQ T7S323PKJS XK4IUX8MNB N94C2U587S
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
54532-0024-5	1 BOTTLE, WITH APPLICATOR in 1 CARTON (54532-0024-5) / 50 mL in 1 BOTTLE, WITH APPLICATOR	01 Apr, 2016	N/A	No
54532-0024-6	1 BOTTLE, WITH APPLICATOR in 1 CARTON (54532-0024-6) / 10 mL in 1 BOTTLE, WITH APPLICATOR	01 Apr, 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

Hevert Trauma Roll-on

Arnica Montana Root & more..

Gel
Hevert Arzneimittel GmbH & Co KG
NDC: 54532-0024

Purpose:

Active ingredients purpose arnica montana, radix 3x relief of minor aches and pains bellis perennis 1x calendula officinalis 1x hamamelis virginiana 1x hypericum perforatum 6x millefolium 1x ruta graveolens 4x symphytum officinale 6x "x" indicates a homeopathic dilution. for more information visit: www.hevertusa.com

Product Elements:

Hevert trauma roll-on arnica montana root, bellis perennis, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, hypericum perforatum, achillea millefolium flowering top, ruta graveolens flowering top, and comfrey root arnica montana root arnica montana root bellis perennis whole bellis perennis whole calendula officinalis flowering top calendula officinalis flowering top hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark hypericum perforatum whole hypericum perforatum whole achillea millefolium flowering top achillea millefolium flowering top ruta graveolens flowering top ruta graveolens flowering top comfrey root comfrey root hydroxypropyl cellulose (1600000 wamw) isopropyl alcohol water weak yellow

Indications and Usage:

Uses for the temporary relief of minor aches and pains, such as: muscle pain and stiffness bruising and swelling claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated .

Warnings:

Warnings for external use only do not use if you are allergic to arnica montana, calendula officinalis (common marigold) or other plants from the daisy family (compositae), or to any of the ingredients of this product when using this product avoid contact with eyes or mucous membranes do not apply to wounds, damaged or irritated skin stop use and ask a doctor if condition persists for more than 3 days or gets worse new symptoms occur keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

When Using:

When using this product avoid contact with eyes or mucous membranes do not apply to wounds, damaged or irritated skin

Dosage and Administration:

Directions for external use only adults and children over 6 years of age: apply a thin layer of this product to the affected area 3â4 times daily.

Stop Use:

Stop use and ask a doctor if condition persists for more than 3 days or gets worse new symptoms occur

Package Label Principal Display Panel:

Principal display panel - 50 ml bottle carton ndc 54532-0024-5 hevert Â® trauma roll- on homeopathic topical pain relieving gel gentle relief from minor aches and pains with the power of arnica ! 1.7 fl oz (50 ml) hevert principal display panel - 50 ml bottle carton

Further Questions:

Questions? 1-855-387-6466

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.