Label: KIDNEY - BLADDER- 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

  • 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 April 15, 2014

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  • INDICATIONS & USAGE SECTION

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

  • DOSAGE & ADMINISTRATION SECTION

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

  • OTC - ACTIVE INGREDIENT SECTION

    Apis mel. 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Cinchona 15x, Equisetum hyem. 15x, Ferrum phos. 15x, Gelsemium 15x, Juniperus com. 15x, Pareira 15x, Phos. 15x, Plantago 15x, Pulsatilla 15x, Sabal 15x, Terebinthina 15x, Uva-ursi 15x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.

  • OTC - PURPOSE SECTION

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

  • INACTIVE INGREDIENT SECTION

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

  • QUESTIONS SECTION

    www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256

  • WARNINGS SECTION

    Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    KIDNEY - BLADDER  
    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:55714-8006
    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 Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil15 [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, Unspecified3 [hp_X]  in 1 mL
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 mL
    Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root3 [hp_X]  in 1 mL
    Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-8006-129.57 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/15/2014
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-8006)
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