H. PYLORI KIT- helicobacter pylori kit

H. Pylori Kit by

Drug Labeling and Warnings

H. Pylori 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:

Helicobacter Pylori 15X, 20X, 30X, 60X, 90X, 120X, 150X, 200X, 500X, 1000X.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to H. Pylori infection including loss of appetite, belching, nausea, vomiting and fatigue.**

**These statements are based upon 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 a physician or 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 a physician or Poison Control Center right away.

DIRECTIONS:

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 H. Pylori infection including loss of appetite, belching, nausea, vomiting and fatigue.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized Water, Ethanol 25%

QUESTIONS:

Dist. By:

Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

SERIES THERAPY

HOMEOPATHIC

BARTONELLA

FOR PROFESSIONAL USE ONLY
10 vials, 2 ml each

INGREDIENTS AND APPEARANCE

H. PYLORI KIT 
helicobacter pylori kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43742-0928

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0928-1	1 in 1 CARTON	11/28/2016
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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0929
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0929-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0930
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0930-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0931
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0931-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0932
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0932-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0933
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0933-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0934
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0934-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0935
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0935-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0936
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0936-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0937
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0937-1	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

H. PYLORI KIT 
helicobacter pylori liquid

Product Information
Item Code (Source)	NDC: 43742-0938
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	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: 43742-0938-1	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		11/28/2016

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43742-0928) , api manufacture(43742-0928) , label(43742-0928) , pack(43742-0928)