Label: BLADDER INCONTINENCE FORMULA- belladonna, bellis perennis, benzoicum acidum, benzoicum acidum, causticum, equisetum hyemale, lycopodium clavatum, phosphorus, plantago major, rhus aromatica, sepia 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 September 5, 2014

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  • DOSAGE & ADMINISTRATION

    Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

    Adult Dose: 3 Pump Sprays

    Child's Dose (2-12): 2 Pump Sprays

    Infants - 2 yrs: 1 Pump Spray

  • WARNINGS

    Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Other information: Tamper resistant for your protection. Use only if safety seal is intact.

  • PURPOSE

    Indications: For temporary relief of: •involuntary urination •urinary leakage with strain, sneeze, or laughter •frequent urination •burning while urinating •associated back pain

  • ACTIVE INGREDIENT

    Active Ingredients: Belladonna, Bellis perennis, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia. ​Equal volumes of each ingredient in 10X, 30X, 100X potencies.

  • INACTIVE INGREDIENT

    Inactive Ingredient: Citric acid, potassium sorbate, purified water.

  • INDICATIONS & USAGE

    Indications: For temporary relief of:

    • involuntary urination
    • urinary leakage with strain, sneeze, or laughter
    • frequent urination
    • burning while urinating
    • associated back pain

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BLADDER INCONTINENCE FORMULA 
    belladonna, bellis perennis, benzoicum acidum, benzoicum acidum, causticum, equisetum hyemale, lycopodium clavatum, phosphorus, plantago major, rhus aromatica, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66579-0078
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 59 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS10 [hp_X]  in 59 mL
    BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID10 [hp_X]  in 59 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 59 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE10 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 59 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR10 [hp_X]  in 59 mL
    RHUS AROMATICA ROOT BARK (UNII: Q3H36W0J42) (RHUS AROMATICA ROOT BARK - UNII:Q3H36W0J42) RHUS AROMATICA ROOT BARK10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66579-0078-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/05/2014
    Labeler - New Sun Inc. (957251176)
    Registrant - New Sun Inc. (957251176)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(66579-0078)
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