Label: BLADDER - KIDNEY- apis mel., berber. vulg., bryonia, cantharis, cinchona, equisetum hyemale, ferrum phosphoricum, gelsemium, juniperus com., pareira, phosphorus, plantago, pulsatilla, sabal, terebinthina, uva-ursi, echinacea, hydrastis, lappa, solidago liquid

  • NDC Code(s): 55714-2388-0, 55714-2388-1, 55714-2388-2
  • Packager: Newton Laboratories, 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 November 24, 2020

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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a doctor before use.

  • WARNINGS SECTION

    Warning:Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

  • QUESTIONS SECTION

    newtonlabs.net ~ Questions? 800.448.7256

    Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Echinacea 6x, Hydrastis 6x, Lappa 6x, Solidago 6x., Apis mel. 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Cinchona 15x, Equisetum hyemale 15x, Ferrum phos.15x, Gelsemium 15x, Juniperus com. 15x, Pareira 15x, Phosp. 15x, Plantago 15x, Pulsatilla 15x, Sabal 15x, Terebinthina 15x, Uva-ursi 15x.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • INDICATIONS & USAGE SECTION

    Bladder - Kidney Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.

  • PACKAGE LABEL

    Package label

  • INGREDIENTS AND APPEARANCE
    BLADDER - KIDNEY 
    apis mel., berber. vulg., bryonia, cantharis, cinchona, equisetum hyemale, ferrum phosphoricum, gelsemium, juniperus com., pareira, phosphorus, plantago, pulsatilla, sabal, terebinthina, uva-ursi, echinacea, hydrastis, lappa, solidago liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2388
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA15 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK15 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA15 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE15 [hp_X]  in 1 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE15 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
    JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL) JUNIPER BERRY15 [hp_X]  in 1 mL
    CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT15 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR15 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS15 [hp_X]  in 1 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO15 [hp_X]  in 1 mL
    TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G) TURPENTINE15 [hp_X]  in 1 mL
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF15 [hp_X]  in 1 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT6 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2388-00.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/01/201808/01/2018
    2NDC:55714-2388-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/29/2018
    3NDC:55714-2388-250 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/01/201808/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2018
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2388)
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