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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 Label Information

Updated March 10, 2022

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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