Label: IRRITABLE BOWELCARE- aloe socotrina, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colocynthis, croton tiglium, gelsemium sempervirens, gratiola officinalis, nux vomica,phosphoricum acidum, podophyllum peltatum and veratrum album 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 13, 2012

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  • Active Ingredients


    HPUS active ingredients

    Equal volumes of each ingredient in 10X, 30X and LM1 potencies.

    Aloe socotrina, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Croton tiglium, Gelsemium sempervirens, Gratiola officinalis, Nux vomica,Phosphoricum acidum, Podophyllum peltatum and Veratrum album.

    Reference image bowelcare.jpg
  • Inactive Ingredients

    Purified water, Potassium sorbate and citric acid.

    Reference image bowelcare.jpg

  • Purpose

    HPUS active ingredients                                     Purpose

    Equal volumes of each ingredient in 10X, 30X and LM1 potencies.

    Aloe socotrina...............................................................diarrhea, mucus in stools
    Carbo vegetabilis...........................................................stomach cramps, gas, nausea
    Chamomilla...................................................................abdominal pain, bloating, gas
    Cinchona officinalis........................................................loose stools, abdominal pain
    Collinsonia canadensis...................................................rectal pain, constipation
    Colocynthis...................................................................abdominal cramps, pain
    Croton tiglium................................................................sudden evacuation of stools
    Gelsemium sempervirens...............................................urgent need to pass stools
    Gratiola officinalis..........................................................stomach cramps, diarrhea
    Nux Vomica..................................................................alternating constipation and diarrhea
    Phosphoricum acidum...................................................diarrhea, gas, bloating
    Podophyllum peltatum....................................................alternating constipation and diarrhea
    Veratrum album.............................................................irregularity, difficult elimination

    Reference image bowelcare.jpg

  • Indications and Usage


    Uses for temporary relief of irritable bowel symptoms:

    • diarrhea
    • abdominal pain
    • alternating constipation and diarrhea
    • bloating
    • gas
    • nausea
    • abdominal cramps
    • mucus in stools
    • urgent need to pass stools
    • irregularity
    • difficult elimination
    as per various homeopathic Materia Medicas.
  • Warnings

    • If symptoms persist or worsen, seek advice of a physician.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
    • Keep out of reach of children.
    Other information
    Tamper resistant for your protection. Use only if safety seal is intact.

    Reference image bowelcare.jpg
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Dosage and Administration

    Directions

    • Initially, depress pump until primed.
    • Hold bottle close to mouth and spray one dose directly into mouth
    • Adults and children 12 years and older:3 pumps sprays.
    • Use from 3 to 6 times per day as needed.
    Reference image bowelcare.jpg
  • PRINCIPAL DISPLAY PANEL

    Image of carton


    King Bio, Inc.

    3 Westside Drive

    Asheville, NC 28806

    For questions or more information about homeopathy call 800-543-3245 or www.safe-care.com

  • INGREDIENTS AND APPEARANCE
    IRRITABLE BOWELCARE 
    aloe socotrina, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colocynthis, croton tiglium, gelsemium sempervirens, gratiola officinalis, nux vomica,phosphoricum acidum, podophyllum peltatum and veratrum album liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-4020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE10 [hp_X]  in 29.6 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL10 [hp_X]  in 29.6 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 29.6 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 29.6 mL
    COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT10 [hp_X]  in 29.6 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP10 [hp_X]  in 29.6 mL
    CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED10 mL  in 29.6 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 29.6 mL
    GRATIOLA OFFICINALIS (UNII: BDD9991A36) (GRATIOLA OFFICINALIS - UNII:BDD9991A36) GRATIOLA OFFICINALIS10 [hp_X]  in 29.6 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 29.6 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID10 [hp_X]  in 29.6 mL
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM10 [hp_X]  in 29.6 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT10 [hp_X]  in 29.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-4020-11 in 1 CARTON
    129.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/13/2011
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture
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