Label: BIRTH EASE- aletris farinosa, apis mellifica, arnica montana, belladonna, caulophyllum thalictroides, chamomilla, cimicifuga racemosa, ferrum metallicum, kali carbonicum, sabina, secale cornutum, viburnum opulus 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 June 19, 2012

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  • Active Ingredients

    Official HPUS: Aletris farinosa, Apis mellifica, Arnica montana, Belladonna, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Ferrum metallicum, Kali carbonicum, Sabina, Secale cornutum, Viburnum opulus.


    Reference image: birthease.jpg

  • Inactive Ingredient

    Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

    Reference image: birthease.jpg

  • Purposes

    Uses natural assistance for strengthening and toning of the female reproductive system in preparation for birth:

    • tones female organs
    • for pains during birth
    • helps to restore the reproductive system after birth
    To be taken in the last or 9th month of pregnancy.

    Reference image: birthease.jpg
  • Dosage and Administration

    Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed.

    Adult Dose - 3 pump sprays

    Children 2-12 years - 2 pump sprays

    Reference image: birthease.jpg

  • Warnings

    If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

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

    Reference image: birthease.jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Reference image: birthease.jpg

  • Indications and Usage

    Natural assistance for strengthening and toning of the female reproductive system in preparations for birth: tones female organs, for pains during birth, helps to restore the reproductive system after birth. To be taken in the last or 9th month of pregnancy.

    Reference image: birthease.jpg

  • PRINCIPAL DISPLAY PANEL


    Image of label


    King Bio, Inc.

    3 Westside Dr.

    Asheville, NC 28806

    Questions? Call 800.543.3245

    www.kingbio.com

  • INGREDIENTS AND APPEARANCE
    BIRTH EASE 
    aletris farinosa, apis mellifica, arnica montana, belladonna, caulophyllum thalictroides, chamomilla, cimicifuga racemosa, ferrum metallicum, kali carbonicum, sabina, secale cornutum, viburnum opulus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALETRIS FARINOSA ROOT (UNII: O021JGR97X) (ALETRIS FARINOSA ROOT - UNII:O021JGR97X) ALETRIS FARINOSA ROOT10 [hp_X]  in 59 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 59 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]  in 59 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 59 mL
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 59 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON10 [hp_X]  in 59 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CARBONATE10 [hp_X]  in 59 mL
    JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1) JUNIPERUS SABINA LEAFY TWIG10 [hp_X]  in 59 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM10 [hp_X]  in 59 mL
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5002-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/28/2011
    Labeler - King Bio, Inc. (617901350)
    Registrant - King Bio, Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio, Inc.617901350manufacture
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