Label: COMPRE TOX- eriodictyon californicum, hamamelis virginiana, nymphaea odorata, plantago major, xanthoxylum fraxineum, xerophyllum asphodeloides 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 23, 2012

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  • ACTIVE INGREDIENTS

    Eriodictyon Californicum 3X, Hamamelis Virginiana 3X, Nymphaea Odorata 3X, Plantago Major 3X, Xanthoxylum Fraxineum 3X, Xerophyllum Asphodeloides 3X, Yucca Filamentosa 3X, Zingiber Officinale 3X.

  • INDICATIONS

    For temporary relief of symptoms from general toxin exposure.

  • WARNINGS

    Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away. If pregnant or breast-feeding, seek advice of a health professional before use. Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

  • DIRECTIONS

    10 drops orally, 2 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENTS

    Demineralized Water, 25% Ethanol.

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, contact physician or Poison Control Center right away.

  • INDICATIONS AND USAGE

    For temporary relief of symptoms from general toxin exposure.

  • QUESTIONS

    MFD. FOR:

    Navillus

    4217 New Hope Meadow Road

    Heritage, TN 37076

  • PRINCIPAL DISPLAY PANEL

    COMPRE TOX

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Compre tox

  • INGREDIENTS AND APPEARANCE
    COMPRE TOX 
    eriodictyon californicum, hamamelis virginiana, nymphaea odorata, plantago major, xanthoxylum fraxineum, xerophyllum asphodeloides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43965-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ERIODICTYON CALIFORNICUM LEAF (UNII: 2Y7TIQ135H) (ERIODICTYON CALIFORNICUM LEAF - UNII:2Y7TIQ135H) ERIODICTYON CALIFORNICUM LEAF3 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]  in 1 mL
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432) (NYMPHAEA ODORATA ROOT - UNII:69RAZ4C432) NYMPHAEA ODORATA ROOT3 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR3 [hp_X]  in 1 mL
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK3 [hp_X]  in 1 mL
    XEROPHYLLUM ASPHODELOIDES (UNII: 9I4XB1GP2B) (XEROPHYLLUM ASPHODELOIDES - UNII:9I4XB1GP2B) XEROPHYLLUM ASPHODELOIDES3 [hp_X]  in 1 mL
    YUCCA FILAMENTOSA (UNII: T6VR38UJ9I) (YUCCA FILAMENTOSA - UNII:T6VR38UJ9I) YUCCA FILAMENTOSA3 [hp_X]  in 1 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43965-0001-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/28/2012
    Labeler - Kevin Sullivan Navillus (078430938)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43965-0001)
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