BORRELIA BABESIA KIT- babesia microti, borrelia burgdorferi nosode kit

Borrelia Babesia Kit by

Drug Labeling and Warnings

Borrelia Babesia Kit by is a Homeopathic medication manufactured, distributed, or labeled by Deseret Biologicals, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Drive
Sandy, UT 84070     www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

SERIES THERAPY

HOMEOPATHIC

BORRELIA-BABESIA

FOR PROFESSIONAL USE ONLY

10 vials, 2 ml each

INGREDIENTS AND APPEARANCE

BORRELIA BABESIA KIT 
babesia microti, borrelia burgdorferi nosode kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43742-0883

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0883-1	1 in 1 CARTON	10/27/2016
1		1 in 1 DOSE PACK; Type 1: Convenience Kit of Co-Package

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL, SINGLE-DOSE	2 mL
Part 2	1 VIAL, SINGLE-DOSE	2 mL
Part 3	1 VIAL, SINGLE-DOSE	2 mL
Part 4	1 VIAL, SINGLE-DOSE	2 mL
Part 5	1 VIAL, SINGLE-DOSE	2 mL
Part 6	1 VIAL, SINGLE-DOSE	2 mL
Part 7	1 VIAL, SINGLE-DOSE	2 mL
Part 8	1 VIAL, SINGLE-DOSE	2 mL
Part 9	1 VIAL, SINGLE-DOSE	2 mL
Part 10	1 VIAL, SINGLE-DOSE	2 mL

Part 1 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0884
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	15 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	15 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0884-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 2 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0885
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	20 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	20 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0885-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 3 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0886
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	30 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0886-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 4 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0887
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	60 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	60 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0887-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 5 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0888
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	90 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	90 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0888-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 6 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0889
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	120 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	120 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0889-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 7 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0890
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	150 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	150 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0890-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 8 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0891
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	200 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	200 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0891-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 9 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0892
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	500 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	500 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0892-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Part 10 of 10

BORRELIA BABESIA 
babesia microti, borrelia burgdorferi nosode liquid

Product Information
Item Code (Source)	NDC: 43742-0893
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BABESIA MICROTI (UNII: 1948X6KEG3) (BABESIA MICROTI - UNII:1948X6KEG3)	BABESIA MICROTI	1000 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	1000 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0893-1	2 mL in 1 VIAL, SINGLE-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/27/2016

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43742-0883) , api manufacture(43742-0883) , label(43742-0883) , pack(43742-0883)