Label: BIOTOX T- bacillus tetani, ledum palustre liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 16, 2021

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  • ACTIVE INGREDIENTS:

    Bacillus Tetani 30C, 2LM, Ledum Palustre 30C, 2LM.

  • INDICATIONS:

    For symptoms of stiffness, muscle spasms, difficulty swallowing, irritability, excess sweating, anxiety.

  • WARNINGS:

    If you are pregnant or breastfeeding, 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, 5 days per week until symptoms improve, then 3 drops 3 times daily for 3 days per week until symptoms abate. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For symptoms of stiffness, muscle spasms, difficulty swallowing, irritability, excess sweating, anxiety.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Organic Ethanol

  • QUESTIONS:

    MFD FOR:

    The Wellness Center for Research

    and Education, Inc.

    1237 S. Victoria Ave. Suite 169

    Oxnard, CA 93035 

  • PACKAGE LABEL DISPLAY:

    Dr. Theresa Dale's

    NDC 50181-0058-1

    Homeopathic

    BioTox

    T

    1 fl oz (30 ml)

    BioTox T

  • INGREDIENTS AND APPEARANCE
    BIOTOX T 
    bacillus tetani, ledum palustre liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM) CLOSTRIDIUM TETANI30 [hp_C]  in 1 mL
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0058-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/27/2018
    Labeler - The Wellness Center For Research and Education (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0058) , api manufacture(50181-0058) , label(50181-0058) , pack(50181-0058)
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