Label: COMBINATION REMEDY 43 - URINARY INCONTINENCE BED WETTING- causticum, equisetum hyemale, kreosotum, sepia 30x, sulphur, zincum metallicum solution/ drops

  • 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 December 25, 2017

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  • WARNINGS

    Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

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

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • ACTIVE INGREDIENT

    Causticum 30X

    Equisetum Hyemale 30X

    Kreosotum 30X

    Sepia 30X

    Sulphur 30X

    Zincum Metallicum 30X

  • PURPOSE

    Temporary relief from involuntary leakage of urine.

  • INACTIVE INGREDIENT

    Purified Water

    Alcohol

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years and older: Take 10-15 drops in half cup of water 3 times a day.

    Children 2 years to under 12 years: Take 8-10 drops in half cup of water of 3 times a day.

    Children under 2 years: Consult doctor prior to use.

  • INDICATIONS & USAGE

    Temporary relief from involuntary leakage of urine.

  • PRINCIPAL DISPLAY PANEL

    urinary incontinence combo 43.jpg

  • INGREDIENTS AND APPEARANCE
    COMBINATION REMEDY 43 - URINARY INCONTINENCE BED WETTING 
    causticum, equisetum hyemale, kreosotum, sepia 30x, sulphur, zincum metallicum solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69008-4043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE30 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 1 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM30 [hp_X]  in 1 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC30 [hp_X]  in 1 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE30 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69008-4043-120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/15/2017
    Labeler - Warsan Homoeopathic Laboratories (645579772)
    Registrant - Warsan Homoeopathic Laboratories (645579772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Warsan Homoeopathic Laboratories645579772manufacture(69008-4043) , pack(69008-4043) , label(69008-4043)
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