BIOTOX VI (cochlearia armoracia, spleen (bovine), thymus gland (bovine), influenzinum- 2019-2020, mycoplasma pneumoniae, cytomegalovirus nosode, human papilloma nosode, coxsackie b1 nosode, coxsackie b4 nosode, pneumococcinum, carcinosin liquid

BIOTOX by

Drug Labeling and Warnings

BIOTOX by is a Homeopathic medication manufactured, distributed, or labeled by The Wellness Center for Research and Education, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Cochlearia Armoracia 3X, Spleen (Bovine) 8X, Thymus Gland (Bovine) 8X, 1LM, Influenzinum (2019–2020) 10X, 12X, 30X, 30C, 100C, 200C, Mycoplasma Pneumoniae 12X, 15, 30X, 200X, Cytomegalovirus Nosode 12X, 15X, 30X, 30C, 3LM, Human Papilloma Nosode 12X, 18X, 30C, 100C, 200C, Coxsackie B1 Nosode 8C, 9C, 12C, 15C, 30C, Coxsackie B4 Nosode 8C, 9C, 12C, 15C, 30C, Pneumococcinum 30C, Carcinosin 30C, 200C, 3LM.

INDICATIONS:

Fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling and 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 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.

INDICATIONS:

Fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling and stiffness of limbs.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

1-866-962-6484

PACKAGE LABEL DISPLAY:

Dr. Theresa Dale's

NDC: 50181-0062-1

Homeopathic

BioTox

Vi

1 fl oz (30 ml)

INGREDIENTS AND APPEARANCE

BIOTOX  VI
cochlearia armoracia, spleen (bovine), thymus gland (bovine), influenzinum (2019-2020), mycoplasma pneumoniae, cytomegalovirus nosode, human papilloma nosode, coxsackie b1 nosode, coxsackie b4 nosode, pneumococcinum, carcinosin liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50181-0062
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ)	HORSERADISH	3 [hp_X]  in 1 mL
BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3)	BOS TAURUS SPLEEN	8 [hp_X]  in 1 mL
BOS TAURUS THYMUS (UNII: 8XEJ88V2T8) (BOS TAURUS THYMUS - UNII:8XEJ88V2T8)	BOS TAURUS THYMUS	8   in 1 mL
INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: XW4JB03TI5) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:92XE6GHC89)	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	10 [hp_X]  in 1 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 3NZW5ND3D6) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K329YCD1N9)	INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)	10 [hp_X]  in 1 mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8V4458342X) (INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:OES3CXI7E9)	INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED)	10 [hp_X]  in 1 mL
MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0) (MYCOPLASMA PNEUMONIAE - UNII:JQE470FAD0)	MYCOPLASMA PNEUMONIAE	12 [hp_X]  in 1 mL
HUMAN HERPESVIRUS 5 (UNII: 7COI029E6K) (HUMAN HERPESVIRUS 5 - UNII:7COI029E6K)	HUMAN HERPESVIRUS 5	12 [hp_X]  in 1 mL
HUMAN PAPILLOMAVIRUS (UNII: 23CVL7WF4J) (HUMAN PAPILLOMAVIRUS - UNII:23CVL7WF4J)	HUMAN PAPILLOMAVIRUS	12 [hp_X]  in 1 mL
HUMAN COXSACKIEVIRUS B1 (UNII: ADL68M27WD) (HUMAN COXSACKIEVIRUS B1 - UNII:ADL68M27WD)	HUMAN COXSACKIEVIRUS B1	8 [hp_C]  in 1 mL
HUMAN COXSACKIEVIRUS B4 (UNII: FYF75V7FDY) (HUMAN COXSACKIEVIRUS B4 - UNII:FYF75V7FDY)	HUMAN COXSACKIEVIRUS B4	8 [hp_C]  in 1 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2)	STREPTOCOCCUS PNEUMONIAE	30 [hp_C]  in 1 mL
HUMAN BREAST TUMOR CELL (UNII: C62OO7VD9K) (HUMAN BREAST TUMOR CELL - UNII:C62OO7VD9K)	HUMAN BREAST TUMOR CELL	30 [hp_C]  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: 50181-0062-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/09/2020

Labeler - The Wellness Center for Research and Education, Inc. (832363993)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50181-0062) , api manufacture(50181-0062) , label(50181-0062) , pack(50181-0062)