Label: KIDNEY TONIC II (glutathione, kidney (suis), urinary bladder (suis), agrimonia eupatoria flos, apis mellifica, berberis vulgaris, bryonia- alba, calcarea carbonica, galium aparine, rubia tinctorum 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 February 18, 2021

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  • ACTIVE INGREDIENTS:

    Glutathione 6X, Kidney 6X, 12X, 30X, 200X, Urinary Bladder (Suis) 6X, 12X, 30X, 200X, Agrimonia Eupatoria, Flos 8X, Apis Mellifica 12X, Berberis Vulgaris 12X, Bryonia (Alba) 12X, Calcarea Carbonica 12X, Galium Aparine 12X, Rubia Tinctorum 12X.

  • INDICATIONS:

    For temporary relief of burning pain in the region of the kidneys, sticking pain in the region of the kidneys, radiatingaround the abdomen and groin, frequent urination with painin the thighs and loins.

  • 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 burning pain in the region of the kidneys, sticking pain in the region of the kidneys, radiatingaround the abdomen and groin, frequent urination with painin the thighs and loins.

  • 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

    KIDNEY TONIC II

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Kidney Tonic II

  • INGREDIENTS AND APPEARANCE
    KIDNEY TONIC  II
    glutathione, kidney (suis), urinary bladder (suis), agrimonia eupatoria flos, apis mellifica, berberis vulgaris, bryonia (alba), calcarea carbonica, galium aparine, rubia tinctorum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0579
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE6 [hp_X]  in 1 mL
    PORK KIDNEY (UNII: X7BCI5P86H) (PORK KIDNEY - UNII:X7BCI5P86H) PORK KIDNEY6 [hp_X]  in 1 mL
    SUS SCROFA URINARY BLADDER (UNII: 3G7U72W8DA) (SUS SCROFA URINARY BLADDER - UNII:3G7U72W8DA) SUS SCROFA URINARY BLADDER6 [hp_X]  in 1 mL
    AGRIMONIA EUPATORIA FLOWER (UNII: 5811MI029U) (AGRIMONIA EUPATORIA FLOWER - UNII:5811MI029U) AGRIMONIA EUPATORIA FLOWER8 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK12 [hp_X]  in 1 mL
    BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P) BRYONIA ALBA WHOLE12 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
    GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE WHOLE12 [hp_X]  in 1 mL
    RUBIA TINCTORUM ROOT (UNII: 0SVP95L23G) (RUBIA TINCTORUM ROOT - UNII:0SVP95L23G) RUBIA TINCTORUM ROOT12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0579-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/18/2021
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0579) , api manufacture(43857-0579) , label(43857-0579) , pack(43857-0579)
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