NDC 50181-0056 Biotox Lyme

Phytolacca Decandra, Mycoplasma Pneumoniae, Borrelia Burgdorferi Nosode, Ehrlichia Nosode (canine), Babesia Microti, Coxiella Burnetii, Chelidonium Majus, Herpes Zoster Nosode, Francisella Tularensis, Rickettsia Prowazekii

NDC Product Code 50181-0056

NDC Code: 50181-0056

Proprietary Name: Biotox Lyme 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: Phytolacca Decandra, Mycoplasma Pneumoniae, Borrelia Burgdorferi Nosode, Ehrlichia Nosode (canine), Babesia Microti, Coxiella Burnetii, Chelidonium Majus, Herpes Zoster Nosode, Francisella Tularensis, Rickettsia Prowazekii 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.
    • 50181-0056 - Biotox Lyme

NDC 50181-0056-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Biotox Lyme with NDC 50181-0056 is a a human over the counter drug product labeled by The Wellness Center For Research And Education, Inc.. The generic name of Biotox Lyme is phytolacca decandra, mycoplasma pneumoniae, borrelia burgdorferi nosode, ehrlichia nosode (canine), babesia microti, coxiella burnetii, chelidonium majus, herpes zoster nosode, francisella tularensis, rickettsia prowazekii. 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 Lyme 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.

  • PHYTOLACCA AMERICANA ROOT 6 [hp_X]/mL
  • MYCOPLASMA PNEUMONIAE 9 [hp_X]/mL
  • BORRELIA BURGDORFERI 12 [hp_X]/mL
  • EHRLICHIA CANIS 15 [hp_X]/mL
  • BABESIA MICROTI 15 [hp_X]/mL
  • COXIELLA BURNETII 30 [hp_X]/mL
  • CHELIDONIUM MAJUS 6 [hp_C]/mL
  • HUMAN HERPESVIRUS 3 6 [hp_C]/mL
  • FRANCISELLA TULARENSIS 6 [hp_C]/mL
  • RICKETTSIA PROWAZEKII 7 [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: 03-24-2016 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.

Biotox Lyme Product Label Images

Biotox Lyme 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:

Phytolacca Decandra 6X, Mycoplasma Pneumoniae 9X, 15X, 30X, 200X, 30C, Borrelia Burgdorferi Nosode 12X, 30X, 60X, 1LM, Ehrlichia Nosode (Canine) 15X, 30X, , Babesia Microti 15X, 30X, 60X, 5C, Coxiella Burnetii 30X, Chelidonium Majus 6C, Herpes Zoster Nosode 6C, Francisella Tularensis 6C, 12C, 30C, Rickettsia Prowazekii 7C, 15C, 30C.

Indications:

Chronic fatigue, rash, flu-like symptoms, swelling and joint pain (like arthritis), tingling and numbness in your hands, feet and back, brain fog, poor memory, weakness or paralysis in your face muscles.

Chronic fatigue, rash, flu-like symptoms, swelling and joint pain (like arthritis), tingling and numbness in your hands, feet and back, brain fog, poor memory, weakness or paralysis in your face muscles.

Warnings:

If pregnant or breastfeeding, 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 orally 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 Researchand Education, Inc.1237 S. Victoria Ave. Suite 169Oxnard, CA 93035    1-866-962-6484

Package Label Display:

Dr. Theresa Dale'sNDC: 50181-0056-1HomeopathicBioTox Lyme1 fl oz (30 ml)

* Please review the disclaimer below.

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