CYSTOTONE- sarsaparilla, uva-ursi, arsenicum album, cantharis, pareira brava, pulsatilla, sepia, terebinthina, populus tremuloides liquid

Cystotone by

Drug Labeling and Warnings

Cystotone by is a Homeopathic medication manufactured, distributed, or labeled by Energique, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each drop): 14.26% of Arsenicum Album 12X, Cantharis 12X, Pareira Brava 12X, Populus Tremuloides 15X Pulsatilla 12X, Sepia 12X, Terebinthina 12X; 0.10% of Sarsaparilla 3X, Uva Ursi 3X.

INDICATIONS:

May temporarily relieve intolerable urging, pressure in the area of the bladder, and having to urinate often.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

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

​Keep out of reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

DIRECTIONS:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Demineralized Water, 20% Ethanol

KEEP OUT OF REACH OF CHILDREN:

​Keep out of reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS:

May temporarily relieve intolerable urging, pressure in the area of the bladder, and having to urinate often.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579     800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

CYSTOTONE

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

CYSTOTONE 
sarsaparilla, uva-ursi, arsenicum album, cantharis, pareira brava, pulsatilla, sepia, terebinthina, populus tremuloides liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0086
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX ORNATA ROOT	3 [hp_X]  in 1 mL
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36)	ARCTOSTAPHYLOS UVA-URSI LEAF	3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	12 [hp_X]  in 1 mL
CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z)	CHONDRODENDRON TOMENTOSUM ROOT	12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X]  in 1 mL
TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F)	TURPENTINE OIL	12 [hp_X]  in 1 mL
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID)	POPULUS TREMULOIDES BARK	15 [hp_X]  in 1 mL
POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0)	POPULUS TREMULOIDES LEAF	15 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44911-0086-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/15/2013

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0086) , api manufacture(44911-0086) , label(44911-0086) , pack(44911-0086)