Label: ZEEL - arnica montana root, toxicodendron pubescens leaf, solanum dulcamara top, comfrey root, sulfur, sanguinaria canadensis root, sus scrofa cartilage, sus scrofa embryo, sus scrofa umbilical cord, sus scrofa placenta, .alpha.-lipoic acid, coenzyme a, nadide and sodium diethyl oxalacetate injection

  • NDC Code(s): 50114-7030-1, 50114-7030-2
  • Packager: MediNatura
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

Drug Label Information

Updated 12/14

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  • DESCRIPTION

     Each 2.0 ml ampule contains:
     Active Ingredients:
     Ingredient name  Potency  Quantity   Final dilution
     a-Lipoicum acidum  8X  2.0 μl  10.99X
     Arnica montana, radix  4X  200.0 μl  5.00X
     Cartilago suis  6X  2.0 μl  9.00X
     Coenzyme A  8X  2.0 μl  10.99X
     Dulcamara  3X  10.0 μl  5.30X
     Embryo totalis suis  6X  2.0 μl  9.00X
     Funiculus umbilicalis suis  6X  2.0 μl  9.00X
     Nadidum  8X  2.0 μl  10.99X
     Natrum oxalaceticum  8X  2.0 μl  10.99X
     Placenta suis  6X  2.0 μl  9.00X
     Rhus toxicodendron  2X  10.0 μl  4.30X
     Sanguinaria canadensis  4X  3.0 μl  6.82X
     Sulphur  6X  3.6 μl  8.74X
     Symphytum officinale  6X  10.0 μl  8.30X

    Inactive Ingredients

    Water for injection 1,747.4 μl

    Sodium Chloride     17.6 μl

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  • INDICATIONS AND USAGE

    Treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases

    • Zeel® Injection Solution is a homeopathic drug product indicated for the treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.

    Co-administration Therapy with Traumeel® Injection Solution for the treatment of inflammatory and degenerative conditions of the musculoskeletal system.

    • Zeel® Injection Solution is a homeopathic drug product indicated, in combination with Traumeel® Injection Solution, for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness.

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  • DOSAGE AND ADMINISTRATION

    General Considerations

    • The dosage schedules listed below can be used as a general guide for the administration of Zeel® Injection Solution.
    • Zeel® Injection Solution may be administered s.c., i.d., i.m., i.a. or i.v.
    • The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.
    • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Draw up the contents of the ampule into the syringe. Discard half or one third of the contents, depending on the required dosage, before administering.

    Standard Dosage - for the treatment of arthrosis/osteoarthritis and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.

    Adults and children 12 years and older:

    1 ampule 1 to 3 times per 7 days

    Children 6 to 11 years:

    2/3 of an ampule 1 to 3 times per 7 days

    Acute Dosage - for the treatment of arthrosis/osteoarthritis and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.

    Adults and children 12 years and older:

    1 ampule daily, and then continue with standard dosage

    Children 6 to 11 years:

    2/3 of an ampule daily, and then continue with standard dosage

    Co-administration therapy with Traumeel® Injection Solution - for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness.

    • In the treatment of musculoskeletal conditions, if co-administration with another homeopathic medicinal product is desired, Zeel® Injection Solution may be mixed in a ratio of 1:1 with Traumeel® Injection Solution.
    • For convenience, the daily dose of Zeel® Injection Solution may be administered at the same time as a Traumeel® Injection Solution, according to the dosing recommendations for each medication.
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  • CONTRAINDICATIONS

    • Zeel® Injection Solution is contraindicated in patients with known hypersensitivity to Zeel® or any of its ingredients.
    • When Zeel® Injection Solution is co-administered with Traumeel® Injection Solution, refer to the Contraindication section of the respective Traumeel® Injection Solution labeling.
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  • WARNINGS AND PRECAUTIONS

    Keep out of reach of children.

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  • ADVERSE REACTIONS

    Post Marketing Experience

    • The following adverse events have been identified during post-marketing use of Zeel® Injection Solution. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frquency or establish a causal relationship to drug exposure.

    • Adverse event rates observed in Monotherapy use of Zeel® Injection Solution: Allergic (hypersensitivity) skin reactions may occur in isolated cases.

    • Adverse event rates observed in the Monotherapy use of Traumeel® Injection Solution: Allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) may occur in isolated cases.

    To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203

    info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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  • OVERDOSAGE

    No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.

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  • CLINICAL PHARMACOLOGY

    Mechanism of Action

    The exact mechanism of Zeel® Injection Solution is not fully understood.

    Pharmacodynamics

    Not applicable for homeopathic medicinal products.

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  • DOSAGE

    One ampule containing 2.0 ml each containing the active ingredients in the strengths listed under Description.

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  • INGREDIENTS AND APPEARANCE
    ZEEL 
    arnica montana root, toxicodendron pubescens leaf, solanum dulcamara top, comfrey root, sulfur, sanguinaria canadensis root, sus scrofa cartilage, sus scrofa embryo, sus scrofa umbilical cord, sus scrofa placenta, .alpha.-lipoic acid, coenzyme a, nadide and sodium diethyl oxalacetate injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50114-7030
    Route of Administration INTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRA-ARTICULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT 4 [hp_X]  in 2.0 mL
    TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 2 [hp_X]  in 2.0 mL
    SOLANUM DULCAMARA TOP (SOLANUM DULCAMARA TOP) SOLANUM DULCAMARA TOP 3 [hp_X]  in 2.0 mL
    COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 6 [hp_X]  in 2.0 mL
    SULFUR (SULFUR) SULFUR 6 [hp_X]  in 2.0 mL
    SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT 4 [hp_X]  in 2.0 mL
    SUS SCROFA CARTILAGE (SUS SCROFA CARTILAGE) SUS SCROFA CARTILAGE 6 [hp_X]  in 2.0 mL
    SUS SCROFA EMBRYO (SUS SCROFA EMBRYO) SUS SCROFA EMBRYO 6 [hp_X]  in 2.0 mL
    SUS SCROFA UMBILICAL CORD (SUS SCROFA UMBILICAL CORD) SUS SCROFA UMBILICAL CORD 6 [hp_X]  in 2.0 mL
    SUS SCROFA PLACENTA (SUS SCROFA PLACENTA) SUS SCROFA PLACENTA 6 [hp_X]  in 2.0 mL
    .ALPHA.-LIPOIC ACID (.ALPHA.-LIPOIC ACID) .ALPHA.-LIPOIC ACID 8 [hp_X]  in 2.0 mL
    COENZYME A (COENZYME A) COENZYME A 8 [hp_X]  in 2.0 mL
    NADIDE (NADIDE) NADIDE 8 [hp_X]  in 2.0 mL
    SODIUM DIETHYL OXALACETATE (DIETHYL OXALACETATE) SODIUM DIETHYL OXALACETATE 8 [hp_X]  in 2.0 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50114-7030-1 10 in 1 CARTON
    1 2.0 mL in 1 AMPULE
    2 NDC:50114-7030-2 1 in 1 CARTON
    2 2.0 mL in 1 AMPULE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/31/2004
    Labeler - MediNatura (102783016)
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