Label: EDEMA HP- apis mellifica, arsenicum album, digitalis purpurea, ferrum metallicum, lycopodium clavatum, rhus tox, sambucus nigra, strophanthus hispidus 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 April 22, 2020

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  • ACTIVE INGREDIENTS:

    Apis Mellifica 30X, Arsenicum Album 30X, Digitalis Purpurea 30X, Ferrum Metallicum 30X, Lycopodium Clavatum 30X, Rhus Tox 30X, Sambucus Nigra 30X, Strophanthus Hispidus 30X.

  • INDICATIONS:

    For temporary relief of symptoms of 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 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:

    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 of 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

    EDEMA-HP

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Edema-HP

    Edema-HP

  • INGREDIENTS AND APPEARANCE
    EDEMA  HP
    apis mellifica, arsenicum album, digitalis purpurea, ferrum metallicum, lycopodium clavatum, rhus tox, sambucus nigra, strophanthus hispidus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0299
    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
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS30 [hp_X]  in 1 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON30 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP30 [hp_X]  in 1 mL
    STROPHANTHUS HISPIDUS SEED (UNII: MO892VI77K) (STROPHANTHUS HISPIDUS SEED - UNII:MO892VI77K) STROPHANTHUS HISPIDUS SEED30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0299-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/03/2014
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0299) , api manufacture(43857-0299) , label(43857-0299) , pack(43857-0299)
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