NDC | 55714-5006-1, 55714-5006-3 |
Set ID | b7ce22de-1b30-c00a-8ea8-8ac8d92bb657 |
Category | OTC ANIMAL DRUG LABEL |
Packager | Newton Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- 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