NDC 43857-0409 Amoebatox

Triticum Aestivum, Baptisia Tinctoria, Capsicum Annuum, Frasera Caroliniensis, Hamamelis Virginiana, Hydrastis Canadensis, Quassia Amara, Senna, Hydrastis Canadensis, Hepar Bovine, Pancreas Suis, Spleen (bovine), Belladonna, Cinchona Officinalis, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Entamoeba Histolytica, Giardia Lamblia30

NDC Product Code 43857-0409

NDC Code: 43857-0409

Proprietary Name: Amoebatox 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, Baptisia Tinctoria, Capsicum Annuum, Frasera Caroliniensis, Hamamelis Virginiana, Hydrastis Canadensis, Quassia Amara, Senna, Hydrastis Canadensis, Hepar Bovine, Pancreas Suis, Spleen (bovine), Belladonna, Cinchona Officinalis, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Entamoeba Histolytica, Giardia Lamblia30 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.

NDC 43857-0409-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Amoebatox with NDC 43857-0409 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Amoebatox is triticum aestivum, baptisia tinctoria, capsicum annuum, frasera caroliniensis, hamamelis virginiana, hydrastis canadensis, quassia amara, senna, hydrastis canadensis, hepar bovine, pancreas suis, spleen (bovine), belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, entamoeba histolytica, giardia lamblia30. 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.

Amoebatox 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
  • BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL
  • CAPSICUM 3 [hp_X]/mL
  • ALPINE STRAWBERRY 3 [hp_X]/mL
  • FRASERA CAROLINIENSIS ROOT 3 [hp_X]/mL
  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X]/mL
  • QUASSIA AMARA WOOD 3 [hp_X]/mL
  • SENNA LEAF 3 [hp_X]/mL
  • GOLDENSEAL 5 [hp_X]/mL
  • BEEF LIVER 8 [hp_X]/mL
  • SUS SCROFA PANCREAS 8 [hp_X]/mL
  • BOS TAURUS SPLEEN 8 [hp_X]/mL
  • ATROPA BELLADONNA 12 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 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
  • ENTAMOEBA HISTOLYTICA 15 [hp_C]/mL
  • GIARDIA LAMBLIA 15 [hp_C]/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.

  • MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU)
  • 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: 08-18-2016 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.

Amoebatox Product Label Images

Amoebatox 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 MT, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Fragaria Vesca 3X, Frasera Caroliniensis 3X, Hamamelis Virginiana 3X, Quassia Amara 3X, Senna 3X, Hydrastis Canadensis 5X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Entamoeba Histolytica 15C, 30C, 100C, Giardia Lamblia 15C, 30C, 100C.

Indications:

For temporary relief of symptoms of diarrhea, mucousy stools, intestinal bloating.

For temporary relief of symptoms of diarrhea, mucousy stools, intestinal bloating.

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:

Cajuput (Leaf) Essential Oil, Demineralized Water, 25% Ethanol

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com

Package Label Display:

BIOActive NutritionalAMOEBATOXHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.