NDC 35378-0012 Nobacco Remedy Water

Arsenicum Alb., Benzoicum Acidum, Berber. Vulg, Bryonia, Caladium Seguinum, Cantharis, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Daphne Indica, Ignatia, Iris Versicolor, Lycopodium, Nicotinum, Nux Vom., Rhus Toxicodendron, Scutellaria Lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana

NDC Product Code 35378-0012

NDC Code: 35378-0012

Proprietary Name: Nobacco Remedy Water What is the Proprietary Name?
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: Arsenicum Alb., Benzoicum Acidum, Berber. Vulg, Bryonia, Caladium Seguinum, Cantharis, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Daphne Indica, Ignatia, Iris Versicolor, Lycopodium, Nicotinum, Nux Vom., Rhus Toxicodendron, Scutellaria Lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 35378 - Georgetown Health, Llc Dba Essentialife
    • 35378-0012 - Nobacco Remedy Water

NDC 35378-0012-2

Package Description: 7 CYLINDER in 1 CONTAINER > 1000 mg in 1 CYLINDER

NDC 35378-0012-3

Package Description: 1 CYLINDER in 1 CONTAINER > 1000 mg in 1 CYLINDER

NDC Product Information

Nobacco Remedy Water with NDC 35378-0012 is a a human over the counter drug product labeled by Georgetown Health, Llc Dba Essentialife. The generic name of Nobacco Remedy Water is arsenicum alb., benzoicum acidum, berber. vulg, bryonia, caladium seguinum, cantharis, ceanothus, chelidonium majus, chionanthus virginica, cinchona, daphne indica, ignatia, iris versicolor, lycopodium, nicotinum, nux vom., rhus toxicodendron, scutellaria lateriflora, tabacum, echinacea, taraxacum, valeriana. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Georgetown Health, Llc Dba Essentialife

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

Product Type: Human Otc Drug What kind of product is this?
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.

Nobacco Remedy Water Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ARSENIC TRIOXIDE 15 [hp_X]/mg
  • BENZOIC ACID 15 [hp_X]/mg
  • BERBERIS VULGARIS ROOT BARK 15 [hp_X]/mg
  • BRYONIA ALBA ROOT 15 [hp_X]/mg
  • DIEFFENBACHIA SEGUINE 15 [hp_X]/mg
  • LYTTA VESICATORIA 15 [hp_X]/mg
  • CEANOTHUS AMERICANUS LEAF 15 [hp_X]/mg
  • CHELIDONIUM MAJUS 15 [hp_X]/mg
  • CHIONANTHUS VIRGINICUS BARK 15 [hp_X]/mg
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/mg
  • DAPHNE ODORA BARK 15 [hp_X]/mg
  • STRYCHNOS IGNATII SEED 15 [hp_X]/mg
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mg
  • NICOTINE 15 [hp_X]/mg
  • STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mg
  • TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/mg
  • SCUTELLARIA LATERIFLORA 15 [hp_X]/mg
  • TOBACCO LEAF 15 [hp_X]/mg
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mg
  • TARAXACUM OFFICINALE 3 [hp_X]/mg
  • VALERIAN 3 [hp_X]/mg
  • IRIS VERSICOLOR ROOT 15 [hp_X]/mg

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Georgetown Health, Llc Dba Essentialife
Labeler Code: 35378
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
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.

Start Marketing Date: 07-01-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Nobacco Remedy Water Product Label Images

Nobacco Remedy Water Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Arsenicum album15xBenzoicum acidum15xBerberis vulgaris15xBryonia15xCaladium seguinum15xCantharis15xCeanothus americanus15xChelidonium majus15xChionanthus virginica15xCinchona officinalis15xDaphne indica15xIgnatia amara15xIris versicolor15xLycopodium clavatum15xNicotinum15xNux vomica15xRhus toxicodendron15xScutellaria lateriflora15xTabacum15xEchinacea  3xTaraxacum officinale  3xValeriana officinalis  3x

Purpose

Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Uses

Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Warnings

Do not use if tamper-evident package seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children.

Directions

Ages 12 and up. Remedy Water® homepathic pellets are dispersed via the PowerCap® apparatus. Firmly press PowerCap® dome to release pellets into the bottle of water and shake well. Remedy Water® pellets may not dissolve completely. Drink within four hours. Avoid storing or washing where temperatures may exceed 140 degrees.

Inactive Ingredients

USP/NF neutral pellets (.07% gluten-free, non-GMO, beet-derived sucrose, .03% gluten-free, non-GMO maize starch in 500 ml water)

Other Information

Avoid storing in areas where temperatures may exceed 140 degrees.

Questions?

1.866.777.1277www.EssentiaLife.com

* Please review the disclaimer below.

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