Label: BIOTOX DENTAL FOCI REPAIR- arnica montana, hypericum perforatum, plantago major, aconitum napellus, mercurius solubilis, hekla lava, argentum nitricum, belladonna, hepar sulphuris calcareum, silicea spray

  • NDC Code(s): 50181-0082-1
  • Packager: The Wellness Center For Research and Education
  • 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 February 14, 2022

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

  • ACTIVE INGREDIENTS:

    Arnica Montana 3C, 6C, 30C, 60C, 200C, Hypericum Perforatum 3C, 6C, 30C, 60C, 200C, Plantago Major 3C, 6C, 30C, 60C, 200C, Aconitum Napellus 4C, 6C, 30C, 60C,200C, Mercurius Solubilis 4C, 6C, 30C, 60C,200C, Hekla Lava 6C, 30C, Argentum Nitricum 6C, 30C, 60C, 200C, Belladonna 6C, 30C, 60C, 200C, Hepar Sulphuris Calcareum 6C, 30C, 60C, 200C, Silicea 6C, 30C, 60C, 200C.

  • INDICATIONS:

    For Temporary relief from right-sided tooth discomfort, dental abscess, tooth decay, loose teeth, nerve pain and general oral discomfort, Supports the body's natural slowing of excess bleeding. Promotes healthy gums.

  • 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:

    Spray orally, 2 to 4 sprays twice daily on affected teeth or gums, at least 30 minutes before or after eating. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For Temporary relief from right-sided tooth discomfort, dental abscess, tooth decay, loose teeth, nerve pain and general oral discomfort, Supports the body's natural slowing of excess bleeding. Promotes healthy gums.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Organic Ethanol.

  • QUESTONS:

    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 50181-0082-1

    Homeopathic

    BioTox 

    Dental Foci

    Repair

    1 fl oz (30 ml)

    BioTox Dental Foci Repair

  • INGREDIENTS AND APPEARANCE
    BIOTOX DENTAL FOCI REPAIR 
    arnica montana, hypericum perforatum, plantago major, aconitum napellus, mercurius solubilis, hekla lava, argentum nitricum, belladonna, hepar sulphuris calcareum, silicea spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0082
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE3 [hp_C]  in 1 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE3 [hp_C]  in 1 mL
    PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE3 [hp_C]  in 1 mL
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE4 [hp_C]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS4 [hp_C]  in 1 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA6 [hp_C]  in 1 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE6 [hp_C]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_C]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_C]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0082-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/14/2022
    Labeler - The Wellness Center For Research and Education (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0082, 50181-0082) , api manufacture(50181-0082) , label(50181-0082)