Label: EDEMA HP- apis mellifera 30x, arsenic trioxide 30x, cinchona officinalis bark 30x, digitalis 30x, lachesis muta venom 30x, lycopodium clavatum spore 30x, sodium sulfate 30x, toxicodendron pubescens leaf 30x, sambucus nigra flowering top 30x, strophanthus hispidus seed 30x 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 31, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Apis Mellifica 30C, Arsenicum Album 30C, Cinchona Officinalis 30C, Digitalis Purpurea 30C, Lachesis Mutus 30C, Lycopodium Clavatum 30C, Natrum Sulphuricum 30C, Rhus Toxicodendron 30C, Sambucus Nigra 30C, Strophanthus Hispidus 30C

  • INDICATIONS & USAGE

    USES: Temporarily relieves sensation of soreness, shortness of breath, feeling that deep breaths must be taken, &/or symptoms related to edema.

  • WARNINGS

    WARNING:

    Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

  • DO NOT USE

    OTHER INFORMATION: Tamper Seal: "Sealed for your protection."

    Do not use if seal is broken or missing.

  • REFERENCES

    *The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

  • QUESTIONS

    QUESTIONS AND COMMENTS?

    MFGO FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600

    LOT:

  • PURPOSE

    USES: Temporarily relieves sensation of soreness, shortness of breath, feeling that deep breaths must be taken, &/or symptoms related to edema.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0095-1

    EDEMA HP

    Edema

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    UPC: 877730001313

    Image Of Label

  • INGREDIENTS AND APPEARANCE
    EDEMA HP 
    apis mellifera 30x, arsenic trioxide 30x, cinchona officinalis bark 30x, digitalis 30x, lachesis muta venom 30x, lycopodium clavatum spore 30x, sodium sulfate 30x, toxicodendron pubescens leaf 30x, sambucus nigra flowering top 30x, strophanthus hispidus seed 30x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0095
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_C]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+)30 [hp_C]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK30 [hp_C]  in 1 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS30 [hp_C]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE ANHYDROUS30 [hp_C]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]  in 1 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP30 [hp_C]  in 1 mL
    STROPHANTHUS HISPIDUS SEED (UNII: MO892VI77K) (STROPHANTHUS HISPIDUS SEED - UNII:MO892VI77K) STROPHANTHUS HISPIDUS SEED30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0095-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0095)
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