Terravitals Lobak

Chamomilla, Phosphorus, Platinum Metallicum, Ruta Graveolens, Veratrum Album


Terravitals Llc
Human Otc Drug
NDC 74474-103
Terravitals Lobak also known as Chamomilla, Phosphorus, Platinum Metallicum, Ruta Graveolens, Veratrum Album is a human otc drug labeled by 'Terravitals Llc'. National Drug Code (NDC) number for Terravitals Lobak is 74474-103. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Terravitals Lobak drug includes Chamomile - 6 [hp_C]/1 Phosphorus - 30 [hp_C]/1 Platinum - 30 [hp_C]/1 Ruta Graveolens Flowering Top - 6 [hp_C]/1 Veratrum Album Root - 30 [hp_C]/1 . The currest status of Terravitals Lobak drug is Active.

Drug Information:

Drug NDC: 74474-103
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: Terravitals Lobak
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: Chamomilla, Phosphorus, Platinum Metallicum, Ruta Graveolens, Veratrum Album
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Terravitals Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Pellet
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:CHAMOMILE - 6 [hp_C]/1
PHOSPHORUS - 30 [hp_C]/1
PLATINUM - 30 [hp_C]/1
RUTA GRAVEOLENS FLOWERING TOP - 6 [hp_C]/1
VERATRUM ALBUM ROOT - 30 [hp_C]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 15 Jun, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 14 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:Terravitals LLC
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:FGL3685T2X
27YLU75U4W
49DFR088MY
N94C2U587S
QNS6W5US1Z
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
74474-103-011 BOTTLE, DISPENSING in 1 TUBE (74474-103-01) / 1 PELLET in 1 BOTTLE, DISPENSING15 Jun, 2021N/ANo
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.

Purpose:

Terravitals lobak purpose active ingredients** ...................................................................... purpose chamomilla officinalis 6c hpus.................. lumbago and pain in sacrum phosphorus 30c hpus............................................ burning pain in back platinum metallicum 30c hpus.... spasmodic pain, numbness in coccyx ruta graveolens 6c hpus..................pain in sacrum, lumbar vertebreae veratrum album 30c hpus...................stiffness to sacrum, small of back 'hpus' indicates that this ingredient is officially included in the homeopathic pharmacopoeia of the united states **'c' is homeopathic dilution. uses* for temporary relief of lower back and lumbar pain due to minor muscle strain. *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

Terravitals lobak chamomilla, phosphorus, platinum metallicum, ruta graveolens, veratrum album sucrose phosphorus phosphorus chamomile chamomile ruta graveolens flowering top ruta graveolens flowering top veratrum album root veratrum album root platinum platinum white spheroids

Indications and Usage:

Directions: adults and adolescents 12 and over: dissolve 1-2 pellets in mouth at the onset of symptoms, repeat every 1- 6 hours as needed

Warnings:

Terravitals warnings warnings stop use and ask a doctor if symptoms persist more than 5 days or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children.

Do Not Use:

Terravitals warnings warnings stop use and ask a doctor if symptoms persist more than 5 days or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children.

Dosage and Administration:

Terravitals dosage oral soluble pellets

Package Label Principal Display Panel:

Terravitals lobak main panel terravitals lobak homeopathic medicine relieves lower back pain* ndc 74474-103-01 approx 75 oral soluble pellets non-drowsy not habit-forming no drug interactions no known side effects made in the usa by terravitals llc, gaithersburg md 20879 www.terravitals.com exp: mm/yyyy lot: yyadxx outer packaging label: external label lobak


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.