Label: BIOTOX VI (cochlearia armoracia, spleen (bovine), thymus gland- bovine, influenzinum, mycoplasma pneumoniae, cytomegalovirus, hpv, coxsackie b1, coxsackie b4, pneumococcinum, carcinosin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated December 8, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Cochlearia Armoracia 3X, Spleen (Bovine) 8X, Thymus Gland (Bovine) 8X, 1LM, Influenzinum 10X, 12X, 30X, 30C, 100C, 200C, Mycoplasma Pneumoniae 12X, 25, 30X, 200X, Cytomegalovirus 12X, 15X, 30X, 30C, 3LM, HPV 12X, 28X, 30C, 100C, 200C, 3LM, Coxsackie B1 8C, 9C, 12C, 15C, 30C, Coxsackie B4 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 2 or 3 times per day, on an empty stomach, 5 days per week 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: 50181-0028-1

    Homeopathic

    BioTox

    Vi

    1 fl oz (30 ml)

    BioTox Vi 1 oz

  • INGREDIENTS AND APPEARANCE
    BIOTOX  VI
    cochlearia armoracia, spleen (bovine), thymus gland (bovine), influenzinum, mycoplasma pneumoniae, cytomegalovirus, hpv, coxsackie b1, coxsackie b4, pneumococcinum, carcinosin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0028
    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 [hp_X]  in 1 mL
    INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS10 [hp_X]  in 1 mL
    INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA B VIRUS - UNII:1314JZ2X6W) INFLUENZA B VIRUS10 [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:50181-0028-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/08/2014
    Labeler - The Wellness Center for Research and Education, Inc. (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0028) , api manufacture(50181-0028) , label(50181-0028) , pack(50181-0028)