NDC 43857-0311 Systemic Detox

Berberis Vulgaris, Boldo, Hydrastis Canadensis, Lappa Major, Sanguinaria Canadensis, Taraxacum Officinale, Trifolium Pratense, Condurango, Ginkgo Biloba, Tabebuia Impetiginosa, Conium Maculatum, Hepar Sulphuris Calcareum, Lycopodium Clavatum, Sarsaparilla, Aloe, Echinacea (angustifolia), Natrum Sulphuricum, Nux Vomica, Thuja Occidentalis

NDC Product Code 43857-0311

NDC Code: 43857-0311

Proprietary Name: Systemic Detox 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: Berberis Vulgaris, Boldo, Hydrastis Canadensis, Lappa Major, Sanguinaria Canadensis, Taraxacum Officinale, Trifolium Pratense, Condurango, Ginkgo Biloba, Tabebuia Impetiginosa, Conium Maculatum, Hepar Sulphuris Calcareum, Lycopodium Clavatum, Sarsaparilla, Aloe, Echinacea (angustifolia), Natrum Sulphuricum, Nux Vomica, Thuja Occidentalis 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

  • 43857 - Bioactive Nutritional, Inc.
    • 43857-0311 - Systemic Detox

NDC 43857-0311-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Systemic Detox with NDC 43857-0311 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Systemic Detox is berberis vulgaris, boldo, hydrastis canadensis, lappa major, sanguinaria canadensis, taraxacum officinale, trifolium pratense, condurango, ginkgo biloba, tabebuia impetiginosa, conium maculatum, hepar sulphuris calcareum, lycopodium clavatum, sarsaparilla, aloe, echinacea (angustifolia), natrum sulphuricum, nux vomica, thuja occidentalis. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Systemic Detox 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.

  • BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL
  • PEUMUS BOLDUS LEAF 3 [hp_X]/mL
  • GOLDENSEAL 3 [hp_X]/mL
  • ARCTIUM LAPPA ROOT 3 [hp_X]/mL
  • SANGUINARIA CANADENSIS ROOT 3 [hp_X]/mL
  • TARAXACUM OFFICINALE 3 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 3 [hp_X]/mL
  • MARSDENIA CONDURANGO BARK 6 [hp_X]/mL
  • GINKGO 6 [hp_X]/mL
  • TABEBUIA IMPETIGINOSA BARK 6 [hp_X]/mL
  • CONIUM MACULATUM FLOWERING TOP 12 [hp_X]/mL
  • CALCIUM SULFIDE 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • SMILAX REGELII ROOT 12 [hp_X]/mL
  • ALOE 30 [hp_X]/mL
  • ECHINACEA ANGUSTIFOLIA 30 [hp_X]/mL
  • SODIUM SULFATE 30 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/mL
  • THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_X]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Bioactive Nutritional, Inc.
Labeler Code: 43857
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: 07-22-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 08-05-2019 What is the End Marketing Date?
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.

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.

Systemic Detox Product Label Images

Systemic Detox 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:

Berberis Vulgaris 3X, Boldo 3X, Hydrastis Canadensis 3X, Lappa Major 3X, Sanguinaria Canadensis 3X, Taraxacum Officinale 3X, Trifolium Pratense 3X, Condurango 6X, Ginko Biloba 6X, Tabebuia Impetiginosa 6X, Conium Maculatum 12X, Hepar Sulphuris Calcareum 12X, Lycopodium Clavatum 12X, Sarsaparilla (Smilax Regelii) 12X, Aloe 30X, Echinacea (Angustifolia) 30X, Natrum Sulphuricum 30X, Nux Vomica 30X, Thuja Occidentalis 30X

Indications:

For temporary relief of diarrhea (painless, clay colored); eczema with itching; hay fever, offensive discharge running from the nose, and dyspepsia with bitter taste.

For temporary relief of diarrhea (painless, clay colored); eczema with itching; hay fever, offensive discharge running from the nose, and dyspepsia with bitter taste.

Warnings:

If pregnant or breast-feeding, ask a health care professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.Store in cool, dry place.

Keep Out Of Reach Of Children.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

Demineralized Water, 25% Ethanol

Questions:

Distributed by:BIOACTIVE NUTRITIONALMelbourne, FL 32935For Nutritional Information write:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935

Package Label Display

BioActive HomeopathicSYSTEMIC DETOX1 FL OZ (30 ml)

* Please review the disclaimer below.

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