Label: BIOTOX HEP (cochlearia armoracia, chelidonium majus, arsenicum album, hepar suis, spleen (suis), thymus- suis, hepatitis c nosode, hepatitis a nosode, hepatitis b nosode 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 October 15, 2015

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  • ACTIVE INGREDIENTS:

    Cochlearia Armoracia 3X, Chelidonium Majus 3X, 6X, 8X, Arsenicum Album 6X, 8X, 12X, 30C, Hepar Suis 8X, 12X 30C, Spleen (Suis) 8X, 30C, Thymus (Suis) 8X, 1LM, Hepatitis C Nosode 17X, 30C, 60C, 1M, Hepatitis A Nosode 17X, 30C, 3LM, Hepatitis B Nosode 32X, 30C, 3LM.

  • INDICATIONS:

    Fatigue, fever, cough, flu-like symptoms, 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 or until symptoms abate. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    Fatigue, fever, cough, flu-like symptoms, 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 50181-0055-1

    Homeopathic

    BioTox

    Hep

    1 fl oz (30 ml)

    BioTox Hep

  • INGREDIENTS AND APPEARANCE
    BIOTOX HEP 
    cochlearia armoracia, chelidonium majus, arsenicum album, hepar suis, spleen (suis), thymus (suis), hepatitis c nosode, hepatitis a nosode, hepatitis b nosode liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0055
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_X]  in 1 mL
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER8 [hp_X]  in 1 mL
    SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN8 [hp_X]  in 1 mL
    SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS8 [hp_X]  in 1 mL
    HEPATITIS C VIRUS (UNII: QI56415283) (HEPATITIS C VIRUS - UNII:QI56415283) HEPATITIS C VIRUS17 [hp_X]  in 1 mL
    HEPATITIS A VIRUS (UNII: G54MT8V18G) (HEPATITIS A VIRUS - UNII:G54MT8V18G) HEPATITIS A VIRUS17 [hp_X]  in 1 mL
    HEPATITIS B VIRUS (UNII: 77H9EM77P7) (HEPATITIS B VIRUS - UNII:77H9EM77P7) HEPATITIS B VIRUS32 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0055-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/15/2015
    Labeler - The Wellness Center for Research and Education, Inc. (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0055) , api manufacture(50181-0055) , label(50181-0055) , pack(50181-0055)
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