Label: SYSTEMIC DETOX (berberis vulgaris, boldo, chelidonium majus, lappa major, taraxacum officinale, trifolium pratense, hydrastis canadensis, condurango, ginkgo biloba, tabebuia impetiginosa, conium maculatum, hepar sulphuris calcareum, lycopodium clavatum, sarsaparilla (smilax regelii), aloe, echinacea- angustifolia, natrum sulphuricum, nux vomica, thuja occidentalis 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 March 1, 2017

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

  • ACTIVE INGREDIENTS:

    Berberis Vulgaris 3X, Boldo 3X, Chelidonium Majus 3X, Lappa Major 3X, Taraxacum Officinale 3X, Trifolium Pratense 3X, Hydrastis Canadensis 5X, Condurango 6X, Ginkgo Biloba 6X, Tabebuia Impetiginosa 6X, Conium Maculatum 12X, Hepar Sulphuris Calcareum 12X, Lycopodium Clavatum 12X, Sarsaparilla (Smilax Regelii) 12X, Aloe 30X, Echinacea (Angustifolia) 30X, Natrum Sulphuricum 30X, Nux Vomica 30X, Thuja Occidentalis 30X.

  • INDICATIONS:

    For temporary relief of diarrhea (painless, clay colored); eczema with itching; hay fever, offensive discharge running from the nose, and dyspepsia with bitter taste.

  • 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 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:

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

  • INDICATIONS:

    For temporary relief of diarrhea (painless, clay colored); eczema with itching; hay fever, offensive discharge running from the nose, and dyspepsia with bitter taste.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    SYSTEMIC DETOX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Systemic Detox

  • INGREDIENTS AND APPEARANCE
    SYSTEMIC DETOX 
    berberis vulgaris, boldo, chelidonium majus, lappa major, taraxacum officinale, trifolium pratense, hydrastis canadensis, condurango, ginkgo biloba, tabebuia impetiginosa, conium maculatum, hepar sulphuris calcareum, lycopodium clavatum, sarsaparilla (smilax regelii), aloe, echinacea (angustifolia), natrum sulphuricum, nux vomica, thuja occidentalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0435
    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
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT3 [hp_X]  in 1 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 1 mL
    MARSDENIA CONDURANGO BARK (UNII: R23QIR6YBA) (MARSDENIA CONDURANGO BARK - UNII:R23QIR6YBA) MARSDENIA CONDURANGO BARK6 [hp_X]  in 1 mL
    GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO6 [hp_X]  in 1 mL
    TABEBUIA IMPETIGINOSA BARK (UNII: 6GLA1946WX) (HANDROANTHUS IMPETIGINOSUS BARK - UNII:6GLA1946WX) TABEBUIA IMPETIGINOSA BARK6 [hp_X]  in 1 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP12 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX REGELII ROOT12 [hp_X]  in 1 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE30 [hp_X]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA30 [hp_X]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE30 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0435-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2017
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0435) , api manufacture(43857-0435) , label(43857-0435) , pack(43857-0435)