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 
Newton Laboratories, Inc.

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.

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V004 U-Care

INDICATIONS & USAGE SECTION

U-Care:  Formulated for symptoms such as frequent urination, irritation and incontinence.

DOSAGE & ADMINISTRATION SECTION

Directions:  Pets, under 50 lbs., give 3 drops by mouth (50 to 500 lbs. - 6 drops, over 500 lbs. - 1/2 teaspoon) one to four times daily or as directed by a health professional. Place in mouth or purified water.

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

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

QUESTIONS SECTION

newtonlabs.net  Questions? 1.800.448.7256 
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

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

PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

Package Label
package label
package 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
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-5006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera20 [hp_X]  in 1 mL
Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark20 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root20 [hp_X]  in 1 mL
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria20 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark20 [hp_X]  in 1 mL
Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale20 [hp_X]  in 1 mL
Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate20 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root20 [hp_X]  in 1 mL
Juniper Berry (UNII: O84B5194RL) (Juniper Berry - UNII:O84B5194RL) Juniper Berry20 [hp_X]  in 1 mL
Chondrodendron Tomentosum Root (UNII: 395A3P448Z) (Chondrodendron Tomentosum Root - UNII:395A3P448Z) Chondrodendron Tomentosum Root20 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus20 [hp_X]  in 1 mL
Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major20 [hp_X]  in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris20 [hp_X]  in 1 mL
Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto20 [hp_X]  in 1 mL
Turpentine Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil20 [hp_X]  in 1 mL
Arctostaphylos Uva-ursi Leaf (UNII: 3M5V3D1X36) (Arctostaphylos Uva-ursi Leaf - UNII:3M5V3D1X36) Arctostaphylos Uva-ursi Leaf20 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified8 [hp_X]  in 1 mL
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal8 [hp_X]  in 1 mL
Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root8 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top8 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-5006-129.57 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/01/201112/31/2018
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 liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-5055
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera20 [hp_X]  in 1 mL
Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark20 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root20 [hp_X]  in 1 mL
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria20 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark20 [hp_X]  in 1 mL
Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale20 [hp_X]  in 1 mL
Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate20 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root20 [hp_X]  in 1 mL
Juniper Berry (UNII: O84B5194RL) (Juniper Berry - UNII:O84B5194RL) Juniper Berry20 [hp_X]  in 1 mL
Chondrodendron Tomentosum Root (UNII: 395A3P448Z) (Chondrodendron Tomentosum Root - UNII:395A3P448Z) Chondrodendron Tomentosum Root20 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus20 [hp_X]  in 1 mL
Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major20 [hp_X]  in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris20 [hp_X]  in 1 mL
Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto20 [hp_X]  in 1 mL
Turpentine Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil20 [hp_X]  in 1 mL
Arctostaphylos Uva-ursi Leaf (UNII: 3M5V3D1X36) (Arctostaphylos Uva-ursi Leaf - UNII:3M5V3D1X36) Arctostaphylos Uva-ursi Leaf20 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified11 [hp_X]  in 1 mL
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal11 [hp_X]  in 1 mL
Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root11 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top11 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-5055-129.57 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/15/201112/31/2018
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 liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-5057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera20 [hp_X]  in 1 mL
Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark20 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root20 [hp_X]  in 1 mL
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria20 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark20 [hp_X]  in 1 mL
Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale20 [hp_X]  in 1 mL
Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate20 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root20 [hp_X]  in 1 mL
Juniper Berry (UNII: O84B5194RL) (Juniper Berry - UNII:O84B5194RL) Juniper Berry20 [hp_X]  in 1 mL
Chondrodendron Tomentosum Root (UNII: 395A3P448Z) (Chondrodendron Tomentosum Root - UNII:395A3P448Z) Chondrodendron Tomentosum Root20 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus20 [hp_X]  in 1 mL
Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major20 [hp_X]  in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris20 [hp_X]  in 1 mL
Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto20 [hp_X]  in 1 mL
Turpentine Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil20 [hp_X]  in 1 mL
Arctostaphylos Uva-ursi Leaf (UNII: 3M5V3D1X36) (Arctostaphylos Uva-ursi Leaf - UNII:3M5V3D1X36) Arctostaphylos Uva-ursi Leaf20 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified11 [hp_X]  in 1 mL
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal11 [hp_X]  in 1 mL
Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root11 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top11 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-5057-130 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/01/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE, API MANUFACTURE

Revised: 8/2019
Document Id: f008072f-fe09-49a6-9ef8-ccd62dead92d
Set id: b7ce22de-1b30-c00a-8ea8-8ac8d92bb657
Version: 3
Effective Time: 20190801
 
Newton Laboratories, Inc.