Your browser does not support JavaScript! 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 [HEEL INC]
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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
[Heel Inc]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved homeopathic
NOTE: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 Sections

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

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.

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.

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.

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

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.

OVERDOSAGE

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

CLINICAL PHARMACOLOGY

Mechanism of Action

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

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

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

Zeel Injection carton v.5.jpg

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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50114-7030
Route of AdministrationINTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRA-ARTICULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT4 [hp_X]  in 2.0 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF2 [hp_X]  in 2.0 mL
SOLANUM DULCAMARA TOP (SOLANUM DULCAMARA TOP) SOLANUM DULCAMARA TOP3 [hp_X]  in 2.0 mL
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT6 [hp_X]  in 2.0 mL
SULFUR (SULFUR) SULFUR6 [hp_X]  in 2.0 mL
SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT4 [hp_X]  in 2.0 mL
SUS SCROFA CARTILAGE (SUS SCROFA CARTILAGE) SUS SCROFA CARTILAGE6 [hp_X]  in 2.0 mL
SUS SCROFA EMBRYO (SUS SCROFA EMBRYO) SUS SCROFA EMBRYO6 [hp_X]  in 2.0 mL
SUS SCROFA UMBILICAL CORD (SUS SCROFA UMBILICAL CORD) SUS SCROFA UMBILICAL CORD6 [hp_X]  in 2.0 mL
SUS SCROFA PLACENTA (SUS SCROFA PLACENTA) SUS SCROFA PLACENTA6 [hp_X]  in 2.0 mL
.ALPHA.-LIPOIC ACID (.ALPHA.-LIPOIC ACID) .ALPHA.-LIPOIC ACID8 [hp_X]  in 2.0 mL
COENZYME A (COENZYME A) COENZYME A8 [hp_X]  in 2.0 mL
NADIDE (NADIDE) NADIDE8 [hp_X]  in 2.0 mL
SODIUM DIETHYL OXALACETATE (DIETHYL OXALACETATE) SODIUM DIETHYL OXALACETATE8 [hp_X]  in 2.0 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-7030-110 in 1 CARTON
12.0 mL in 1 AMPULE
2NDC:50114-7030-21 in 1 CARTON
22.0 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/2004
Labeler - Heel Inc (102783016)

Revised: 10/2013
 
Heel Inc

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