Label: HKI- atropinum sulphuricum, benzoicum acidum, berberis vulgaris, calcarea carbonica, colocynthis, coccus cacti, lapis albus, lithium carbonicum, lycopodium clavatum, oryctolagus cuniculus kidney, rubia tinctorum, sarsaparilla, urtica urens 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 31, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:

    Atropinum sulphuricum 6X

    Benzoicum acidum 6X
    Berberis vulgaris (Barberry) Bark 5X
    Calcarea carbonica 12X
    Colocynthis (Bitter apple) Dried fruit 6X

    Coccus cacti (Cochineal) 5X

    Lapis albus (Gastein rock) 12CH

    Lithium carbonicum 6X
    Lycopodium clavatum (Clubmoss) Spores 5X
    Oryctolagus cuniculus (Rabbit) Kidney 10X

    Rubia tinctorum (Madder) Root 4X
    Sarsaparilla Root 1X

    Urtica urens (Dwarf Nettle) Aerial parts 1X

  • PURPOSE

    Uses

    Helps promote and maintain healthy kidney and urinary tract functions.

  • WARNINGS

    Warnings
    Stop use and ask a doctor if symptoms persist or worsen.
    If pregnant or breastfeeding, 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.

    Contains Shellfish (oyster)

  • STOP USE

    Stop use and ask a doctor if symptoms persist or worsen.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Ethanol (beet), purified water

  • OTHER SAFETY INFORMATION

    Other information

    Store in a cool, dry place.

    Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.

  • DO NOT USE

    Use only if safety seal is intact.

  • DOSAGE & ADMINISTRATION

    Directions

    To be taken 20 minutes away from food.

    Place drops directly under the tongue or into ¼ oz of water.

    Adults and adolescents (12 years and older): Take 10 drops two to three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years): Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses

    Helps promote and maintain healthy kidney and urinary tract functions.

    Directions

    To be taken 20 minutes away from food.

    Place drops directly under the tongue or into ¼ oz of water.

    Adults and adolescents (12 years and older): Take 10 drops two to three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years): Take under the direction of your healthcare practitioner.

  • PRINCIPAL DISPLAY PANEL

    Genestra Brands

    NDC 62106-0625-0

    HKI

    HOMEOPATHIC PREPARATION

    To help promote and maintain
    kidney and urinary tract health.

    Contains 48% Alcohol

    1 fl oz (30 mL)

    HKI PDPHKI warnings

  • INGREDIENTS AND APPEARANCE
    HKI 
    atropinum sulphuricum, benzoicum acidum, berberis vulgaris, calcarea carbonica, colocynthis, coccus cacti, lapis albus, lithium carbonicum, lycopodium clavatum, oryctolagus cuniculus kidney, rubia tinctorum, sarsaparilla, urtica urens liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-0625
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE6 [hp_X]  in 30 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 30 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]  in 30 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE5 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS KIDNEY (UNII: 482QQ7H44Q) (ORYCTOLAGUS CUNICULUS KIDNEY - UNII:482QQ7H44Q) ORYCTOLAGUS CUNICULUS KIDNEY10 [hp_X]  in 30 mL
    SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SARSAPARILLA1 [hp_X]  in 30 mL
    CALCIUM HEXAFLUOROSILICATE (UNII: 2NVP93XVQ3) (CALCIUM HEXAFLUOROSILICATE - UNII:2NVP93XVQ3) CALCIUM HEXAFLUOROSILICATE12 [hp_C]  in 30 mL
    BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID6 [hp_X]  in 30 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI5 [hp_X]  in 30 mL
    LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE6 [hp_X]  in 30 mL
    RUBIA TINCTORUM ROOT (UNII: 0SVP95L23G) (RUBIA TINCTORUM ROOT - UNII:0SVP95L23G) RUBIA TINCTORUM ROOT4 [hp_X]  in 30 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS1 [hp_X]  in 30 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK5 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-0625-01 in 1 CARTON12/14/2015
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/14/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-0625)
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