Urinary Care: Homeopathic Product Information

URINARY CARE- apis mellifera, berberis vulgaris root bark, bryonia alba root, lytta vesicatoria, cinchona officinalis bark, equisetum hyemale, ferrosoferric phosphate, gelsemium sempervirens root, juniper berry, chondrodendron tomentosum root, phosphorus, plantago major, pulsatilla vulgaris, saw palmetto, turpentine oil, arctostaphylos uva-ursi leaf, echinacea, unspecified, goldenseal, arctium lappa root and solidago virgaurea flowering top liquid
U-CARE- apis mellifera, berberis vulgaris root bark, bryonia alba root, lytta vesicatoria, cinchona officinalis bark, equisetum hyemale, ferrosoferric phosphate, gelsemium sempervirens root, juniper berry, chondrodendron tomentosum root, phosphorus, plantago major, pulsatilla vulgaris, saw palmetto, turpentine oil, arctostaphylos uva-ursi leaf, echinacea, unspecified, goldenseal, arctium lappa root and solidago virgaurea flowering top 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.

Package Labelpackage labelpackage label

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
(click image for full-size original)
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 Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-5006
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Apis Mellifera (Apis Mellifera) Apis Mellifera 20 [hp_X] in 1 mL
Berberis Vulgaris Root Bark (Berberis Vulgaris Root Bark) Berberis Vulgaris Root Bark 20 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root 20 [hp_X] in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria 20 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark 20 [hp_X] in 1 mL
Equisetum Hyemale (Equisetum Hyemale) Equisetum Hyemale 20 [hp_X] in 1 mL
Ferrosoferric Phosphate (Ferrosoferric Phosphate) Ferrosoferric Phosphate 20 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root 20 [hp_X] in 1 mL
Juniper Berry (Juniper Berry) Juniper Berry 20 [hp_X] in 1 mL
Chondrodendron Tomentosum Root (Chondrodendron Tomentosum Root) Chondrodendron Tomentosum Root 20 [hp_X] in 1 mL
Phosphorus (Phosphorus) Phosphorus 20 [hp_X] in 1 mL
Plantago Major (Plantago Major) Plantago Major 20 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris 20 [hp_X] in 1 mL
Saw Palmetto (Saw Palmetto) Saw Palmetto 20 [hp_X] in 1 mL
Turpentine Oil (Turpentine Oil) Turpentine Oil 20 [hp_X] in 1 mL
Arctostaphylos Uva-ursi Leaf (Arctostaphylos Uva-ursi Leaf) Arctostaphylos Uva-ursi Leaf 20 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified 8 [hp_X] in 1 mL
Goldenseal (Goldenseal) Goldenseal 8 [hp_X] in 1 mL
Arctium Lappa Root (Arctium Lappa Root) Arctium Lappa Root 8 [hp_X] in 1 mL
Solidago Virgaurea Flowering Top (Solidago Virgaurea Flowering Top) Solidago Virgaurea Flowering Top 8 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55714-5006-1 29.57 mL in 1 BOTTLE, GLASS None
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 liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-5055
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Apis Mellifera (Apis Mellifera) Apis Mellifera 20 [hp_X] in 1 mL
Berberis Vulgaris Root Bark (Berberis Vulgaris Root Bark) Berberis Vulgaris Root Bark 20 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root 20 [hp_X] in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria 20 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark 20 [hp_X] in 1 mL
Equisetum Hyemale (Equisetum Hyemale) Equisetum Hyemale 20 [hp_X] in 1 mL
Ferrosoferric Phosphate (Ferrosoferric Phosphate) Ferrosoferric Phosphate 20 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root 20 [hp_X] in 1 mL
Juniper Berry (Juniper Berry) Juniper Berry 20 [hp_X] in 1 mL
Chondrodendron Tomentosum Root (Chondrodendron Tomentosum Root) Chondrodendron Tomentosum Root 20 [hp_X] in 1 mL
Phosphorus (Phosphorus) Phosphorus 20 [hp_X] in 1 mL
Plantago Major (Plantago Major) Plantago Major 20 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris 20 [hp_X] in 1 mL
Saw Palmetto (Saw Palmetto) Saw Palmetto 20 [hp_X] in 1 mL
Turpentine Oil (Turpentine Oil) Turpentine Oil 20 [hp_X] in 1 mL
Arctostaphylos Uva-ursi Leaf (Arctostaphylos Uva-ursi Leaf) Arctostaphylos Uva-ursi Leaf 20 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified 11 [hp_X] in 1 mL
Goldenseal (Goldenseal) Goldenseal 11 [hp_X] in 1 mL
Arctium Lappa Root (Arctium Lappa Root) Arctium Lappa Root 11 [hp_X] in 1 mL
Solidago Virgaurea Flowering Top (Solidago Virgaurea Flowering Top) Solidago Virgaurea Flowering Top 11 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Alcohol
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55714-5055-1 29.57 mL in 1 BOTTLE, GLASS None
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 liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-5057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Apis Mellifera (Apis Mellifera) Apis Mellifera 20 [hp_X] in 1 mL
Berberis Vulgaris Root Bark (Berberis Vulgaris Root Bark) Berberis Vulgaris Root Bark 20 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root 20 [hp_X] in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria 20 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark 20 [hp_X] in 1 mL
Equisetum Hyemale (Equisetum Hyemale) Equisetum Hyemale 20 [hp_X] in 1 mL
Ferrosoferric Phosphate (Ferrosoferric Phosphate) Ferrosoferric Phosphate 20 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root 20 [hp_X] in 1 mL
Juniper Berry (Juniper Berry) Juniper Berry 20 [hp_X] in 1 mL
Chondrodendron Tomentosum Root (Chondrodendron Tomentosum Root) Chondrodendron Tomentosum Root 20 [hp_X] in 1 mL
Phosphorus (Phosphorus) Phosphorus 20 [hp_X] in 1 mL
Plantago Major (Plantago Major) Plantago Major 20 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris 20 [hp_X] in 1 mL
Saw Palmetto (Saw Palmetto) Saw Palmetto 20 [hp_X] in 1 mL
Turpentine Oil (Turpentine Oil) Turpentine Oil 20 [hp_X] in 1 mL
Arctostaphylos Uva-ursi Leaf (Arctostaphylos Uva-ursi Leaf) Arctostaphylos Uva-ursi Leaf 20 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified 11 [hp_X] in 1 mL
Goldenseal (Goldenseal) Goldenseal 11 [hp_X] in 1 mL
Arctium Lappa Root (Arctium Lappa Root) Arctium Lappa Root 11 [hp_X] in 1 mL
Solidago Virgaurea Flowering Top (Solidago Virgaurea Flowering Top) Solidago Virgaurea Flowering Top 11 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Alcohol
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55714-5057-1 30 mL in 1 BOTTLE, GLASS None
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 Operations
Newton Laboratories, Inc. 788793610 MANUFACTURE, API MANUFACTURE

Revised: 08/2019 Newton Laboratories, Inc.

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