KIDNEY-TONE- agrimonia eupatoria, berberis vulgaris, calcarea oxalica, calcarea phosphorica, cantharis, echinacea, equisetum arv

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AGRIMONIA EUPATORIA WHOLE (UNII: EBU0U94820) (AGRIMONIA EUPATORIA WHOLE - UNII:EBU0U94820), BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U), CALCIUM OXALATE MONOHYDRATE (UNII: 4PP86KK527) (CALCIUM - UNII:SY7Q814VUP), TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB), LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT), ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8), EQUI
Available from:
Energetix Corp
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporary relief of frequent urge to urinate; dark, scanty or cloudy urine; lower back pain. Temporary relief of frequent urge to urinate; dark, scanty or cloudy urine; lower back pain.
Authorization status:
unapproved homeopathic
Authorization number:
64578-0084-1

KIDNEY-TONE- agrimonia eupatoria, berberis vulgaris, calcarea oxalica, calcarea phosphorica,

cantharis, echinacea, equisetum arvense, ferrum phosphoricum, lycopodium clavatum, pareira

brava, petroselinum sativum, rubia tinctorum, sarsaparilla, solidago virgaurea, uva-ursi liquid

Energetix Corp

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 Facts:

ACTIVE INGREDIENTS:

Agrimonia Eupatoria 12X, Berberis Vulgaris 4X, 6X, Calcarea Oxalica 12X, 30X, Calcarea

Phosphorica 12X, 30X, Cantharis 12X, Echinacea 4X, Equisetum Arvense 12X, Ferrum Phosphoricum

12X, Lycopodium Clavatum 12X, Pareira Brava 4X, Petroselinum Sativum 4X, Rubia Tinctorum 12X,

Sarsaparilla 5X, Solidago Virgaurea 5X, Uva-Ursi 5X.

PURPOSE:

Temporary relief of frequent urge to urinate; dark, scanty or cloudy urine; lower back pain.

WARNINGS:

In case of overdose, get medical help or call a Poison Control Center right away.

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

Keep out of reach of children.

Other Information

Store in cool, dry place out of direct sunlight.

Do not use if neck wrap is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right

away.

DIRECTIONS:

Take 30 drops orally twice daily or as directed by a healthcare professional.

Consult a physician for use in children under 12 years of age.

USES:

Temporary relief of frequent urge to urinate; dark, scanty or cloudy urine; lower back pain.

INACTIVE INGREDIENTS:

Purified Water, Glycerin, 15% Ethyl Alcohol.

QUESTIONS:

Distributed by

Energetix Corp

Dahlonega, GA 30533

Questions? 800.990.7085

PACKAGE LABEL DISPLAY:

energetix

Kidney-Tone

Homeopathic Remedy

Frequent urge to urinate; dark, scanty or

cloudy urine; lower back pain.

2 fl oz (59.1 mL)

KIDNEY-TONE

agrimonia eupatoria, berberis vulgaris, calcarea oxalica, calcarea phosphorica, cantharis, echinacea, equisetum

arvense, ferrum phosphoricum, lycopodium clavatum, pareira brava, petroselinum sativum, rubia tinctorum,

sarsaparilla, solidago virgaurea, uva-ursi liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 4578 -0 0 8 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AGRIMO NIA EUPATO RIA WHO LE (UNII: EBU0 U9 48 20 ) (AGRIMONIA EUPATORIA

WHOLE - UNII:EBU0 U9 48 20 )

AGRIMONIA EUPATORIA

WHOLE

12 [hp_X]

in 1 mL

BERBERIS VULGARIS RO O T BARK (UNII: 1TH8 Q20 J0 U) (BERBERIS VULGARIS

ROOT BARK - UNII:1TH8 Q20 J0 U)

BERBERIS VULGARIS ROOT

BARK

4 [hp_X]

in 1 mL

CALCIUM O XALATE MO NO HYDRATE (UNII: 4PP8 6 KK527) (CALCIUM -

CALCIUM OXALATE

12 [hp_X]

UNII:SY7Q8 14VUP)

MONOHYDRATE

in 1 mL

TRIBASIC CALCIUM PHO SPHATE (UNII: 9 1D9 GV0 Z28 ) (CALCIUM CATION -

UNII:2M8 3C4R6 ZB)

CALCIUM CATION

12 [hp_X]

in 1 mL

LYTTA VESICATO RIA (UNII: 3Q0 34RO3BT) (LYTTA VESICATORIA -

UNII:3Q0 34RO3BT)

LYTTA VESICATORIA

12 [hp_X]

in 1 mL

ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 ) (ECHINACEA ANGUSTIFOLIA -

UNII:VB0 6 AV5US8 )

ECHINACEA ANGUSTIFOLIA

4 [hp_X]

in 1 mL

EQ UISETUM ARVENSE TO P (UNII: 1DP6 Y6 B6 5Z) (EQUISETUM ARVENSE TOP -

UNII:1DP6 Y6 B6 5Z)

EQUISETUM ARVENSE TOP

12 [hp_X]

in 1 mL

FERRUM PHO SPHO RICUM (UNII: 9 1GQH8 I5F7) (FERROSOFERRIC PHOSPHATE -

UNII:9 1GQH8 I5F7)

FERRUM PHOSPHORICUM

12 [hp_X]

in 1 mL

LYCO PO DIUM CLAVATUM SPO RE (UNII: C8 8 X29 Y479 ) (LYCOPODIUM CLAVATUM

SPORE - UNII:C8 8 X29 Y479 )

LYCOPODIUM CLAVATUM

SPORE

12 [hp_X]

in 1 mL

CHO NDRO DENDRO N TO MENTO SUM RO O T (UNII: 39 5A3P448 Z)

(CHONDRODENDRON TOMENTOSUM ROOT - UNII:39 5A3P448 Z)

CHONDRODENDRON

TOMENTOSUM ROOT

4 [hp_X]

in 1 mL

PETRO SELINUM CRISPUM (UNII: 1WZA4Y9 2EX) (PETROSELINUM CRISPUM -

UNII:1WZA4Y9 2EX)

PETROSELINUM CRISPUM

4 [hp_X]

in 1 mL

RUBIA TINCTO RUM RO O T (UNII: 0 SVP9 5L23G) (RUBIA TINCTORUM ROOT -

UNII:0 SVP9 5L23G)

RUBIA TINCTORUM ROOT

12 [hp_X]

in 1 mL

SARSAPARILLA (UNII: 2H1576 D5WG) (SARSAPARILLA - UNII:2H1576 D5WG)

SARSAPARILLA

5 [hp_X]

in 1 mL

SO LIDAGO VIRGAUREA FLO WERING TO P (UNII: 540 5K23S50 ) (SOLIDAGO

VIRGAUREA FLOWERING TOP - UNII:540 5K23S50 )

SOLIDAGO VIRGAUREA

FLOWERING TOP

5 [hp_X]

in 1 mL

ARCTO STAPHYLO S UVA-URSI LEAF (UNII: 3M5V3D1X36 ) (ARCTOSTAPHYLOS UVA-

URSI LEAF - UNII:3M5V3D1X36 )

ARCTOSTAPHYLOS UVA-

URSI LEAF

5 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 4578 -

0 0 8 4-1

59 .1 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

12/0 5/20 13

Labeler -

Energetix Corp (969572502)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Energetix Corp

Apo the c a

Co mpany

8 44330 9 15

manufacture(6 4578 -0 0 8 4) , api manufacture(6 4578 -0 0 8 4) , label(6 4578 -0 0 8 4) ,

pa c k(6 4578 -0 0 8 4)

Revised: 1/2016

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