NDC 43742-0883 Borrelia Babesia Kit

Babesia Microti, Borrelia Burgdorferi Nosode

NDC Product Code 43742-0883

NDC 43742-0883-1

Package Description: 1 DOSE PACK in 1 CARTON > 1 KIT in 1 DOSE PACK * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0888-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0892-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0891-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0890-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0889-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0893-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0887-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0886-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0885-1) * 2 mL in 1 VIAL, SINGLE-DOSE (43742-0884-1)

NDC Product Information

Borrelia Babesia Kit with NDC 43742-0883 is a a human over the counter drug product labeled by Deseret Biologicals, Inc.. The generic name of Borrelia Babesia Kit is babesia microti, borrelia burgdorferi nosode. The product's dosage form is kit and is administered via form.

Labeler Name: Deseret Biologicals, Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Deseret Biologicals, Inc.
Labeler Code: 43742
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: 10-27-2016 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: 12-31-2020 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.

Borrelia Babesia Kit 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:

Babesia Microti, Borrelia Burgdorferi Nosode, one vial in each of the following dilutions:  15X, 20X, 30X, 60X, 90X, 120X, 150X, 200X, 500X, 1000X.

Homeopathic Indicaitons:

For temporary relief of symptoms related to Lyme Disease including rash, fever, chills, fatigue, and migratory joint pain.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Warnings:

Keep out of reach of children. In case of overdose, contact physician or a Poison Control Center right away.If pregnant or nursing, seek the advice of a health professional before use.If symptoms persist or recur, consult your health practitioner.  Symptoms often become acute between the second and fourth dose as part of the normal healing process.  It is recommended to continue Series Therapy until completion for best results.Tamper seal: "Sealed for Your Protection."DO NOT USE IF SEAL IS BROKEN OR MISSING.

Keep Out Of Reach Of Children:

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

Dosage:

Adults take one vial orally every third day.  Begin with vial #1 then vial #2 three days later, followed by each succeeding numbered vial in three day intervals.  Consult your healthcare provider with any questions.

Homeopathic Indications:

For temporary relief of symptoms related to Lyme Disease including rash, fever, chills, fatigue, and migratory joint pain.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Inactive Ingredients:

Demineralized water, 25% Ethanol

Questions:

Dist. By: Deseret Biologicals, Inc., 469 W. Parkland DriveSandy, UT 84070     www.desbio.com

Package Label Display:

DESBIOSERIES THERAPYHOMEOPATHICBORRELIA-BABESIAFOR PROFESSIONAL USE ONLY10 vials, 2 ml each

* Please review the disclaimer below.