Label: BACTO PLUS HP (apis mellifera, arsenicum album, belladonna, chamomilla, echinacea- angustifolia, lachesis mutus, mercurius solubilis 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 December 8, 2014

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  • ACTIVE INGREDIENTS:

    APIS MELLIFICA 30X,  ARSENICUM ALBUM 30X,  BELLADONNA 30X,  CHAMOMILLA 30X,  ECHINACEA (ANGUSTIFOLIA) 30X,  LACHESIS MUTUS 30X,  MERCURIUS SOLUBILIS 30X,  PULSATILLA (VULGARIS) 30X,  PYROGENIUM 30X,  RHUS TOXICODENDRON 30X,  SILICEA 30X

  • INDICATIONS:

    For temporary relief of symptoms of chronic swelling and inflammation of lymph nodes.

  • WARNINGS:

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a healthcare professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of symptoms of chronic swelling and inflammation of lymph nodes.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 20% Ethanol

  • QUESTIONS:

    Dist. by Dr. Elena M. Morreale

    10031 N. Dale Mabry Hwy.

    Ste. A

    Tampa, FL 33618

    www.drelenamorreale.com

  • PACKAGE LABEL DISPLAY:

    Dr. Elena M. Morreale

    Chiropractic Physician

    BACTO PLUS HP

    Homeopathic Remedy

    1 fl. oz. (30 ml)

    Bacto Plus HP

  • INGREDIENTS AND APPEARANCE
    BACTO PLUS HP 
    apis mellifera, arsenicum album, belladonna, chamomilla, echinacea (angustifolia), lachesis mutus, mercurius solubilis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50813-0010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_X]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA30 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS30 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]  in 1 mL
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50813-0010-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/08/2014
    Labeler - Dr. Elena M. Morreale, Chiropractic Life Center (826038759)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50813-0010) , api manufacture(50813-0010) , label(50813-0010) , pack(50813-0010)
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