CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [ENERGIQUE, INC.]

CYSTOTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [ENERGIQUE, INC.]
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NDC 44911-0086-1
Set ID b296c2bd-d5f6-4de0-abde-8046516a157c
Category HUMAN OTC DRUG LABEL
Packager Energique, Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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 Product01/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/2013
    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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