Label: BED WETTING PREVENTION- belladonna, bellis perennis, 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 November 8, 2016

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS 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, 1M, 1LM, 2LM, 3LM potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep.​

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults: 3 sprays 3 times per day.
    • Children 2-12 years: 2 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses for temporary relief of:

    • involuntary urination during sleep
    • urinary disturbances
    • restless sleep
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BED WETTING PREVENTION 
    belladonna, bellis perennis, benzoicum acidum, causticum, equisetum hyemale, lycopodium clavatum, phosphorus, plantago major, rhus aromatica, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0012
    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
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0012-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/31/2015
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0012)
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