Label: BACTO PLUS- baptisia tinctoria, echinacea, phytolacca decandra, aconitum napellus, arsenicum album, belladonna, ferrum phosphoricum 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 October 10, 2013

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  • ACTIVE INGREDIENTS:

    Baptisia Tinctoria 3X, Echinacea 3X, Phytolacca Decandra 3X, Aconitum Napellus 12X, Arsenicum Album 12X, Belladonna 12X, Ferrum Phosphoricum 12X, Lachesis Mutus 12X, Phosphorus 12X.

  • INDICATIONS:

    For temporary relief of fever, irritated throat, and acute irritation of the bladder.

  • 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 health care professional. If symptoms persist, contsult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of fever, irritated throat, and acute irritation of the bladder.

  • 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 DISPLAY LABEL:

    ​Dr. Elena M. Morreale

    ​Chiropractic Physician

    ​BACTO PLUS

    ​Homeopathic Remedy

    ​1 fl. oz. (30 ml)

    ​ image description

  • INGREDIENTS AND APPEARANCE
    BACTO PLUS 
    baptisia tinctoria, echinacea, phytolacca decandra, aconitum napellus, arsenicum album, belladonna, ferrum phosphoricum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50813-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA3 [hp_X]  in 1 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50813-0001-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/12/2013
    Labeler - Dr. Elena M. Morreale, Chiropractic Life Center (826038759)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50813-0001) , api manufacture(50813-0001) , label(50813-0001) , pack(50813-0001)
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