Label: KIDNEY-TONE- agrimonia eupatoria, berberis vulgaris, calcarea oxalica, calcarea phosphorica, cantharis, echinacea, equisetum arvense, ferrum phosphoricum, lycopodium clavatum, pareira brava, petroselinum sativum, rubia tinctorum, sarsaparilla, solidago virgaurea, uva-ursi 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 January 7, 2016

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  • ACTIVE INGREDIENTS:

    Agrimonia Eupatoria 12X, Berberis Vulgaris 4X, 6X, Calcarea Oxalica 12X, 30X, Calcarea Phosphorica 12X, 30X, Cantharis 12X, Echinacea 4X, Equisetum Arvense 12X, Ferrum Phosphoricum 12X, Lycopodium Clavatum 12X, Pareira Brava 4X, Petroselinum Sativum 4X, Rubia Tinctorum 12X, Sarsaparilla 5X, Solidago Virgaurea 5X, Uva-Ursi 5X.

  • PURPOSE:

    Temporary relief of frequent urge to urinate; dark, scanty or cloudy urine; lower back pain.

  • WARNINGS:

    In case of overdose, get medical help or call a Poison Control Center right away.
    If pregnant or breast-feeding, ask a health professional before use.
    Keep out of reach of children.

    Other Information
    Store in cool, dry place out of direct sunlight.
    Do not use if neck wrap is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

  • DIRECTIONS:

    Take 30 drops orally twice daily or as directed by a healthcare professional.

    Consult a physician for use in children under 12 years of age.

  • USES:

    Temporary relief of frequent urge to urinate; dark, scanty or cloudy urine; lower back pain.

  • INACTIVE INGREDIENTS:

    Purified Water, Glycerin, 15% Ethyl Alcohol.

  • QUESTIONS:

    Distributed by

    Energetix Corp

    Dahlonega, GA 30533

    Questions? 800.990.7085

  • PACKAGE LABEL DISPLAY:

    energetix

    Kidney-Tone

    Homeopathic Remedy

    Frequent urge to urinate; dark, scanty or

    cloudy urine; lower back pain.

    2 fl oz (59.1 mL)

    Kidney-Tone

  • INGREDIENTS AND APPEARANCE
    KIDNEY-TONE 
    agrimonia eupatoria, berberis vulgaris, calcarea oxalica, calcarea phosphorica, cantharis, echinacea, equisetum arvense, ferrum phosphoricum, lycopodium clavatum, pareira brava, petroselinum sativum, rubia tinctorum, sarsaparilla, solidago virgaurea, uva-ursi liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64578-0084
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AGRIMONIA EUPATORIA WHOLE (UNII: EBU0U94820) (AGRIMONIA EUPATORIA WHOLE - UNII:EBU0U94820) AGRIMONIA EUPATORIA WHOLE12 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK4 [hp_X]  in 1 mL
    CALCIUM OXALATE MONOHYDRATE (UNII: 4PP86KK527) (CALCIUM - UNII:SY7Q814VUP) CALCIUM OXALATE MONOHYDRATE12 [hp_X]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA12 [hp_X]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA4 [hp_X]  in 1 mL
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z) EQUISETUM ARVENSE TOP12 [hp_X]  in 1 mL
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT4 [hp_X]  in 1 mL
    PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM4 [hp_X]  in 1 mL
    RUBIA TINCTORUM ROOT (UNII: 0SVP95L23G) (RUBIA TINCTORUM ROOT - UNII:0SVP95L23G) RUBIA TINCTORUM ROOT12 [hp_X]  in 1 mL
    SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SARSAPARILLA5 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP5 [hp_X]  in 1 mL
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF5 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64578-0084-159.1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/05/2013
    Labeler - Energetix Corp (969572502)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(64578-0084) , api manufacture(64578-0084) , label(64578-0084) , pack(64578-0084)
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