Label: EDEMAFORCE (cactus grandiflorus, calendula officinalis, dulcamara, leptandra virginica, solidago virgaurea, convallaria majalis, apis mellifica, arnica montana, berberis vulgaris, bryonia- alba, chelidonium majus, lycopodium clavatum, plumbum metallicum, sambucus nigra liquid

  • NDC Code(s): 43857-0395-1
  • Packager: BioActive Nutritional, Inc.
  • 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 May 31, 2016

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  • ACTIVE INGREDIENTS:

    Cactus Grandiflorus 3X, Calendula Officinalis 3X, Dulcamara 3X, Leptandra Virginica 3X, Solidago Virgaurea 3X, Convallaria Majalis 4X, Apis Mellifica 12X, Arnica Montana 12X, Berberis Vulgaris 12X, Bryonia (Alba) 12X, Chelidonium Majus 12X, Lycopodium Clavatum 12X, Plumbum Metallicum 12X, Sambucus Nigra 12X.

  • INDICATIONS:

    For temporary relief of symptoms due to swelling of the extremities.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care 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 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:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of symptoms due to swelling of the extremities.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    EDEMAFORCE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Edemaforce

  • INGREDIENTS AND APPEARANCE
    EDEMAFORCE 
    cactus grandiflorus, calendula officinalis, dulcamara, leptandra virginica, solidago virgaurea, convallaria majalis, apis mellifica, arnica montana, berberis vulgaris, bryonia (alba), chelidonium majus, lycopodium clavatum, plumbum metallicum, sambucus nigra liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0395
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM3 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP3 [hp_X]  in 1 mL
    VERONICASTRUM VIRGINICUM ROOT (UNII: M2O62YTN42) (CULVER'S ROOT - UNII:M2O62YTN42) VERONICASTRUM VIRGINICUM ROOT3 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]  in 1 mL
    CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS4 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK12 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD12 [hp_X]  in 1 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0395-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/31/2016
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0395) , api manufacture(43857-0395) , label(43857-0395) , pack(43857-0395)
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