NDC 43857-0493 Envirotox

Triticum Aestivum, Berberis Vulgaris, Lappa Major, Rhamnus Cathartica, Rhamnus Purshiana, Phytolacca Decandra, Glycyrrhiza Glabra, Stillingia Sylvatica, Trifolium Pratense, Xanthoxylum Fraxineum, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Belladonna, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum

NDC Product Code 43857-0493

NDC Code: 43857-0493

Proprietary Name: Envirotox 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: Triticum Aestivum, Berberis Vulgaris, Lappa Major, Rhamnus Cathartica, Rhamnus Purshiana, Phytolacca Decandra, Glycyrrhiza Glabra, Stillingia Sylvatica, Trifolium Pratense, Xanthoxylum Fraxineum, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Belladonna, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum 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.
    • 43857-0493 - Envirotox

NDC 43857-0493-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Envirotox with NDC 43857-0493 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Envirotox is triticum aestivum, berberis vulgaris, lappa major, rhamnus cathartica, rhamnus purshiana, phytolacca decandra, glycyrrhiza glabra, stillingia sylvatica, trifolium pratense, xanthoxylum fraxineum, acetone, sodium tripolyphosphate, propylene glycol, sodium benzene sulfonate, ammonium muriaticum, sodium lauryl sulfate, terebinthina, belladonna, lycopodium clavatum, nitricum acidum, nux vomica, phosphoricum acidum. 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.

Envirotox 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.

  • TRITICUM AESTIVUM WHOLE 1 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL
  • ARCTIUM LAPPA ROOT 3 [hp_X]/mL
  • RHAMNUS CATHARTICA FRUIT 3 [hp_X]/mL
  • FRANGULA PURSHIANA BARK 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 4 [hp_X]/mL
  • GLYCYRRHIZA GLABRA 6 [hp_X]/mL
  • STILLINGIA SYLVATICA ROOT 6 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 6 [hp_X]/mL
  • ZANTHOXYLUM AMERICANUM BARK 6 [hp_X]/mL
  • ACETONE 9 [hp_X]/mL
  • SODIUM TRIPOLYPHOSPHATE 12 [hp_X]/mL
  • PROPYLENE GLYCOL 12 [hp_X]/mL
  • SODIUM BENZENESULFONATE 12 [hp_X]/mL
  • AMMONIUM CHLORIDE 12 [hp_X]/mL
  • SODIUM LAURYL SULFATE 12 [hp_X]/mL
  • TURPENTINE OIL 12 [hp_X]/mL
  • ATROPA BELLADONNA WHOLE 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • NITRIC ACID 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • PHOSPHORIC ACID 12 [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: 08-29-2018 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.

Envirotox Product Label Images

Envirotox 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:

Triticum Aestivum 1X, Berberis Vulgaris 3X, Lappa Major 3X, Rhamnus Cathartica 3X, Rhamnus Purshiana 3X, Phytolacca Decandra 4X, Glycyrrhiza Glabra 6X, Stillingia Sylvatica 6X, Trifolium Pratense 6X, Xanthoxylum Fraxineum 6X, Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Sodium Benzene Sulfonate 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Belladonna 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X.

Indications:

For temporary relief of head congestion & general exhaustion as a consequence of exposure to smog, dust, or industrial agents.

For temporary relief of head congestion & general exhaustion as a consequence of exposure to smog, dust, or industrial agents.

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.Contains Wheat.

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 Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com*For a complete list of Environmental Isodes contact BioActive Nutritional, Inc.

Package Label Display:

BIOActive NutritionalENVIROTOXHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.

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