Label: DENTOX (berberis vulgaris, glycyrrhiza glabra, lappa major, phytolacca decandra, stillingia sylvatica, trifolium pratense, lymph node(suis), medulla ossis suis, thymus (suis), thyroidinum- suis, liquid

  • NDC Code(s): 43857-0039-1
  • Packager: BioActive Nutritional, Inc.
  • 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 September 27, 2016

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

  • ACTIVE INGREDIENTS:

    Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Phytolacca Decandra 3X, Stillingia Sylvatica 3X, Trifolium Pratense 3X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Thymus (Suis) 8X, Thyroidinum (Suis) 8X, Calcarea Fluorica 12X, Natrum Fluoratum 12X, Argentum Metallicum 12X, 30X, 60X, 200X, Aurum Metallicum 12X, 30X, 60X, 200X, Cuprum Metallicum 12X, 30X, 60X, 200X, Eugenol 12X, 30X, 60X, 200X, Formalinum 12X, 30X, 60X, 200X, Lidocaine 12X, 30X, 60X, 200X, Mercurius Solubilis 12X, 30X, 60X, 200X, Molybdenum Metallicum 12X, 30X, 60X, 200X, Niccolum Metallicum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X, Stannum Metallicum 12X, 30X, 60X, 200X, Titanium Metallicum 12X, 30X, 60X, 200X, Zincum Metallicum 12X, 30X, 60X, 200X.

  • INDICATIONS:

    For temporary relief of pain and minor inflammation in the mouth or gums following dental procedures.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care 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.

  • DIRECTIONS:

    10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

  • 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.

  • INDICATIONS:

    For temporary relief of pain and minor inflammation in the mouth or gums following dental procedures.

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

    *For a complete list of Dental Isodes contact BioActive Nutritional, Inc.

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    DENTOX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Dentox

  • INGREDIENTS AND APPEARANCE
    DENTOX 
    berberis vulgaris, glycyrrhiza glabra, lappa major, phytolacca decandra, stillingia sylvatica, trifolium pratense, lymph node(suis), medulla ossis suis, thymus (suis), thyroidinum (suis), liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0039
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 1 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA3 [hp_X]  in 1 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT3 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
    STILLINGIA SYLVATICA ROOT (UNII: QBR70R4FBK) (STILLINGIA SYLVATICA ROOT - UNII:QBR70R4FBK) STILLINGIA SYLVATICA ROOT3 [hp_X]  in 1 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
    SUS SCROFA LYMPH (UNII: 33A7VYU29L) (SUS SCROFA LYMPH - UNII:33A7VYU29L) SUS SCROFA LYMPH8 [hp_X]  in 1 mL
    SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8) SUS SCROFA BONE MARROW8 [hp_X]  in 1 mL
    SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS8 [hp_X]  in 1 mL
    THYROID, PORCINE (UNII: 6RV024OAUQ) (THYROID, PORCINE - UNII:6RV024OAUQ) THYROID, PORCINE8 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 1 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION12 [hp_X]  in 1 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER12 [hp_X]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD12 [hp_X]  in 1 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER12 [hp_X]  in 1 mL
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL12 [hp_X]  in 1 mL
    FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525) FORMALDEHYDE12 [hp_X]  in 1 mL
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE12 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM12 [hp_X]  in 1 mL
    NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267) NICKEL12 [hp_X]  in 1 mL
    PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M) PALLADIUM12 [hp_X]  in 1 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN12 [hp_X]  in 1 mL
    TITANIUM (UNII: D1JT611TNE) (TITANIUM - UNII:D1JT611TNE) TITANIUM12 [hp_X]  in 1 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0039-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/05/2012
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0039) , api manufacture(43857-0039) , label(43857-0039) , pack(43857-0039)