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 
The Wellness Center for Research and Education, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

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)

BioTox Vi

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50181-0062
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH3 [hp_X]  in 1 mL
BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN8 [hp_X]  in 1 mL
BOS TAURUS THYMUS (UNII: 8XEJ88V2T8) (BOS TAURUS THYMUS - UNII:8XEJ88V2T8) BOS TAURUS THYMUS8   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 PNEUMONIAE12 [hp_X]  in 1 mL
HUMAN HERPESVIRUS 5 (UNII: 7COI029E6K) (HUMAN HERPESVIRUS 5 - UNII:7COI029E6K) HUMAN HERPESVIRUS 512 [hp_X]  in 1 mL
HUMAN PAPILLOMAVIRUS (UNII: 23CVL7WF4J) (HUMAN PAPILLOMAVIRUS - UNII:23CVL7WF4J) HUMAN PAPILLOMAVIRUS12 [hp_X]  in 1 mL
HUMAN COXSACKIEVIRUS B1 (UNII: ADL68M27WD) (HUMAN COXSACKIEVIRUS B1 - UNII:ADL68M27WD) HUMAN COXSACKIEVIRUS B18 [hp_C]  in 1 mL
HUMAN COXSACKIEVIRUS B4 (UNII: FYF75V7FDY) (HUMAN COXSACKIEVIRUS B4 - UNII:FYF75V7FDY) HUMAN COXSACKIEVIRUS B48 [hp_C]  in 1 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE30 [hp_C]  in 1 mL
HUMAN BREAST TUMOR CELL (UNII: C62OO7VD9K) (HUMAN BREAST TUMOR CELL - UNII:C62OO7VD9K) HUMAN BREAST TUMOR CELL30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50181-0062-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/09/2020
Labeler - The Wellness Center for Research and Education, Inc. (832363993)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(50181-0062) , api manufacture(50181-0062) , label(50181-0062) , pack(50181-0062)

Revised: 3/2020
Document Id: e6bad0ca-7902-40f7-96d2-486a8dce415e
Set id: 5bc05369-ad93-4e91-88bc-aaa6fc7c35ca
Version: 1
Effective Time: 20200309
 
The Wellness Center for Research and Education, Inc.