Label: BIOTOX V MMR (cochlearia armoracia, varicella zoster nosode, spleen (suis), thymus- suis, hepar suis, epstein-barr virus nosode, morbillinum, meningococcus nosode, parotidinum, rubella nosode, poliomyelitis 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 May 19, 2014

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  • ACTIVE INGREDIENTS:

    Cochlearia Armoracia 3X, Varicella Zoster Nosode 6X, 8X, 12X, 30X, 200X, 2LM, Spleen (Suis) 8X, Thymus (Suis) 8X, Hepar Suis 8X, Epstein-Barr Virus Nosode 9X, Morbillinum 12X, 30X, 30C, Meningococcus Nosode 15X, 30X, 200X, Parotidinum 15X, 30X, 200X, Rubella Nosode 30X, Poliomyelitis Nosode 30C.

  • INDICATIONS:

    For temporary relief of skin rash, childhood illness, headache, weight loss, mental and physical fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling, 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:

    For temporary relief of skin rash, childhood illness, headache, weight loss, mental and physical fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling, stiffness of limbs.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESITONS:

    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 50181-0042-1

    Homeopathic

    BioTox

    V-MMR

    1 fl oz (30 ml)

    BioTox V-MMR

  • INGREDIENTS AND APPEARANCE
    BIOTOX  V MMR
    cochlearia armoracia, varicella zoster nosode, spleen (suis), thymus (suis), hepar suis, epstein-barr virus nosode, morbillinum, meningococcus nosode, parotidinum, rubella nosode, poliomyelitis nosode liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH3 [hp_X]  in 1 mL
    HUMAN HERPESVIRUS 3 (UNII: 9885M7D6JP) (HUMAN HERPESVIRUS 3 - UNII:9885M7D6JP) HUMAN HERPESVIRUS 36 [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
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER8 [hp_X]  in 1 mL
    HUMAN HERPESVIRUS 4 (UNII: 2A26YW7PNX) (HUMAN HERPESVIRUS 4 - UNII:2A26YW7PNX) HUMAN HERPESVIRUS 49 [hp_X]  in 1 mL
    MEASLES VIRUS (UNII: HT3R7C012Q) (MEASLES VIRUS - UNII:HT3R7C012Q) MEASLES VIRUS12 [hp_X]  in 1 mL
    JAPANESE ENCEPHALITIS VIRUS (UNII: P07E7XWU9D) (JAPANESE ENCEPHALITIS VIRUS - UNII:P07E7XWU9D) JAPANESE ENCEPHALITIS VIRUS15 [hp_X]  in 1 mL
    MUMPS VIRUS (UNII: YF0S03R447) (MUMPS VIRUS - UNII:YF0S03R447) MUMPS VIRUS15 [hp_X]  in 1 mL
    RUBELLA VIRUS (UNII: U751HEX436) (RUBELLA VIRUS - UNII:U751HEX436) RUBELLA VIRUS30 [hp_X]  in 1 mL
    POLIOVIRUS (UNII: FZJ641678T) (POLIOVIRUS - UNII:FZJ641678T) POLIOVIRUS30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0042-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/19/2014
    Labeler - The Wellness Center for Research and Education, Inc. (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0042) , api manufacture(50181-0042) , label(50181-0042) , pack(50181-0042)
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