NDC 50181-0035 Biotox Gut

Cochlearia Armoracia, Phytolacca Decandra, Chelidonium Majus, Intestinal Mucosa, Spleen, Hepar Bovine, Thymus, Salmonella Enteritidis, Helicobacter Pylori, Nux Vomica, Salmonella Paratyphi, Botulinum

NDC Product Code 50181-0035

NDC Code: 50181-0035

Proprietary Name: Biotox Gut 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: Cochlearia Armoracia, Phytolacca Decandra, Chelidonium Majus, Intestinal Mucosa, Spleen, Hepar Bovine, Thymus, Salmonella Enteritidis, Helicobacter Pylori, Nux Vomica, Salmonella Paratyphi, Botulinum 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

  • 50181 - The Wellness Center For Research And Education, Inc.
    • 50181-0035 - Biotox Gut

NDC 50181-0035-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Biotox Gut with NDC 50181-0035 is a a human over the counter drug product labeled by The Wellness Center For Research And Education, Inc.. The generic name of Biotox Gut is cochlearia armoracia, phytolacca decandra, chelidonium majus, intestinal mucosa, spleen, hepar bovine, thymus, salmonella enteritidis, helicobacter pylori, nux vomica, salmonella paratyphi, botulinum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: The Wellness Center For Research And Education, 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.

Biotox Gut 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.

  • HORSERADISH 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 3 [hp_X]/mL
  • CHELIDONIUM MAJUS 3 [hp_X]/mL
  • BOS TAURUS INTESTINAL MUCOSA 8 [hp_X]/mL
  • SUS SCROFA SPLEEN 8 [hp_X]/mL
  • BEEF LIVER 8 [hp_X]/mL
  • SUS SCROFA THYMUS 8 [hp_X]/mL
  • SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 12 [hp_X]/mL
  • HELICOBACTER PYLORI 15 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 3 [hp_C]/mL
  • SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 15 [hp_C]/mL
  • BOTULINUM TOXIN TYPE A 30 [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.

  • 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: The Wellness Center For Research And Education, Inc.
Labeler Code: 50181
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: 01-03-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

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.

Biotox Gut Product Label Images

Biotox Gut 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:

Cochlearia Armoracia 3X, Phytolacca Decandra 3X, 6X, Chelidonium Majus 3X, 6X, 8X, Intestinal Mucosa (Bovine) 8X, Spleen (Suis) 8X, Hepar Bovine 8X, 30C, Thymus (Suis) 8X, 1LM, Salmonella Enteritidis 12X, 15X 30X, 30C, 60C, Helicobacter Pylori 15X, 30X, 30C, 60C, Nux Vomica 3C, Salmonella Paratyphi 15C, 30C, 60C, Botulinum 30C.

Indications:

Skin rash, headache, mental and physical fatigue, fever, cough, vomiting, flu-like symptoms, heart palpitations, virus, pain, belching, diarrhea, food poisoning, stiffness of limbs.

Skin rash, headache, mental and physical fatigue, fever, cough, vomiting, flu-like symptoms, heart palpitations, virus, pain, belching, diarrhea, food poisoning, stiffness of limbs.

Warnings:

​If pregnant or breast-feeding​ ask a health 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 a 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:

5 drops 2 or 3 times per day, on an empty stomach, 5 days per week or until symptoms abate. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

MFD FOR:The Wellness Center for Research and Education, Inc.1237 S. Victoria Ave. Suite 169Oxnard, CA 930351-866-962-6484

Package Label Display:

Dr. Theresa Dale'sNDC: 50181-0035-1​Homeopathic​BioTox Gut​1 FL OZ (30 ml)

* Please review the disclaimer below.

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