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

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:

(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)

Cystotone

CYSTOTONE 
sarsaparilla, uva-ursi, arsenicum album, cantharis, pareira brava, pulsatilla, sepia, terebinthina, populus tremuloides liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT3 [hp_X]  in 1 mL
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA12 [hp_X]  in 1 mL
CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) ANEMONE PULSATILLA12 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F) TURPENTINE OIL12 [hp_X]  in 1 mL
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID) POPULUS TREMULOIDES BARK15 [hp_X]  in 1 mL
POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF15 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0086-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/18/201702/28/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/15/201302/28/2024
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0086) , api manufacture(44911-0086) , label(44911-0086) , pack(44911-0086)

Revised: 3/2022
 
Energique, Inc.