Label: URINARY CARE- 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
U-CARE- 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): 55714-5006-1, 55714-5055-1, 55714-5057-1
- Packager: Newton Laboratories, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated August 1, 2019
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 11x, Hydrastis 11x, Lappa 11x, Solidago 11x , Apis mel. 20x , Berber. vulg. 20x, Bryonia 20x, Cantharis 20x, Cinchona 20x, Equisetum hyemale 20x, Ferrum phosphoricum 20x, Gelsemium 20x, Juniperus com. 20x, Pareira 20x, Phosphorus 20x, Plantago 20x, Pulsatilla 20x, Sabal 20x, Terebinthina 20x, Uva-ursi 20x.
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
newtonlabs.net Questions? 1.800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
- WARNINGS SECTION
- PREGNANCY OR BREAST FEEDING SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
URINARY CARE
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 liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-5006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 20 [hp_X] in 1 mL Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark 20 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 20 [hp_X] in 1 mL Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 20 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 20 [hp_X] in 1 mL Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale 20 [hp_X] in 1 mL Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate 20 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 20 [hp_X] in 1 mL Juniper Berry (UNII: O84B5194RL) (Juniper Berry - UNII:O84B5194RL) Juniper Berry 20 [hp_X] in 1 mL Chondrodendron Tomentosum Root (UNII: 395A3P448Z) (Chondrodendron Tomentosum Root - UNII:395A3P448Z) Chondrodendron Tomentosum Root 20 [hp_X] in 1 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 20 [hp_X] in 1 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 20 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 20 [hp_X] in 1 mL Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto 20 [hp_X] in 1 mL Turpentine Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil 20 [hp_X] in 1 mL Arctostaphylos Uva-ursi Leaf (UNII: 3M5V3D1X36) (Arctostaphylos Uva-ursi Leaf - UNII:3M5V3D1X36) Arctostaphylos Uva-ursi Leaf 20 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 8 [hp_X] in 1 mL Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 8 [hp_X] in 1 mL Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root 8 [hp_X] in 1 mL Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top 8 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-5006-1 29.57 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2011 12/31/2018 URINARY CARE
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 liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-5055 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 20 [hp_X] in 1 mL Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark 20 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 20 [hp_X] in 1 mL Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 20 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 20 [hp_X] in 1 mL Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale 20 [hp_X] in 1 mL Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate 20 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 20 [hp_X] in 1 mL Juniper Berry (UNII: O84B5194RL) (Juniper Berry - UNII:O84B5194RL) Juniper Berry 20 [hp_X] in 1 mL Chondrodendron Tomentosum Root (UNII: 395A3P448Z) (Chondrodendron Tomentosum Root - UNII:395A3P448Z) Chondrodendron Tomentosum Root 20 [hp_X] in 1 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 20 [hp_X] in 1 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 20 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 20 [hp_X] in 1 mL Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto 20 [hp_X] in 1 mL Turpentine Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil 20 [hp_X] in 1 mL Arctostaphylos Uva-ursi Leaf (UNII: 3M5V3D1X36) (Arctostaphylos Uva-ursi Leaf - UNII:3M5V3D1X36) Arctostaphylos Uva-ursi Leaf 20 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 11 [hp_X] in 1 mL Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 11 [hp_X] in 1 mL Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root 11 [hp_X] in 1 mL Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top 11 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-5055-1 29.57 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/15/2011 12/31/2018 U-CARE
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 liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-5057 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 20 [hp_X] in 1 mL Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark 20 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 20 [hp_X] in 1 mL Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 20 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 20 [hp_X] in 1 mL Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale 20 [hp_X] in 1 mL Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate 20 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 20 [hp_X] in 1 mL Juniper Berry (UNII: O84B5194RL) (Juniper Berry - UNII:O84B5194RL) Juniper Berry 20 [hp_X] in 1 mL Chondrodendron Tomentosum Root (UNII: 395A3P448Z) (Chondrodendron Tomentosum Root - UNII:395A3P448Z) Chondrodendron Tomentosum Root 20 [hp_X] in 1 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 20 [hp_X] in 1 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 20 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 20 [hp_X] in 1 mL Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto 20 [hp_X] in 1 mL Turpentine Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil 20 [hp_X] in 1 mL Arctostaphylos Uva-ursi Leaf (UNII: 3M5V3D1X36) (Arctostaphylos Uva-ursi Leaf - UNII:3M5V3D1X36) Arctostaphylos Uva-ursi Leaf 20 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 11 [hp_X] in 1 mL Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 11 [hp_X] in 1 mL Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root 11 [hp_X] in 1 mL Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top 11 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-5057-1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE, API MANUFACTURE