Label: PSORINOHEEL- sulfur, thuja occidentalis leafy twig, vaccinia virus strain new york city board, gonorrheal urethral secretion human,sodium chloride, nerium oleander leaf,cicuta virosa root, solution

  • Category: HUMAN PRESCRIPTION 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 December 19, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • DESCRIPTION

    Each1.1 ml ampule contains: 

    Ingredient Name

    Potency

    Quantity

    Bacillinum

    12x

    0.55µ

    Bufo rana

    10x

    1.1µ

    Cictuta virosa

    5x

    0.55µ

    Kali bismuthum iodatum

    5x

    0.55 µ

    Medorrhinum

    12x

    1.1µ

    Natrum muriaticum

    12x

    1.1µ

    Oleander

    4x

    0.55µ

    Psorinum

    10x

    1.1µ

    Sulphur

    6x

    1.1µ

    Thuja occidentalis

    6x

    1.1µ

    Vaccinotoxinum

    8x

    1.1µ


    Inactive Ingredient: Isotonic Sodium Chloride solution

  • INDICATION AND USAGE

    Psorinoheel® Oral Vials is a homeopathic drug product indicated for the stimulation of the defense mechanism in chronic skin disorders, hepatic damage , and chronic illness

  • DOSAGE AND ADMINISTRATION

    Dosage:

    Adults and children above 6 years: 1 vial orally 1-3 times daily

    Children up to 6 years: ½ vial orally 1-3 times daily

  • CONTRAINDICATIONS

    Contraindications

    Psorinoheel® Oral Vials are contraindicated in patients with known hypersensitivity to Psorinoheel® or any of its ingredients.

  • WARNINGS AND PRECAUTIONS

    Warnings and Precautions

    None

  • ADVERSE REACTIONS

    No adverse events have been reported with a causal relationship Psorinoheel® Oral Vials.

  • OVERDOSAGE

    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 Psorinoheel®Oral Vials is not fully understood.

    Pharmacodynamics

    Not applicable for homeopathic medicinal products.

  • DOSAGE

    1 oral vial containing 1.1 ml solution for oral administration

  • PRINCIPAL DISPLAY PANEL

    Psorinoheel oral vial.jpg

  • INGREDIENTS AND APPEARANCE
    PSORINOHEEL 
    sulfur, thuja occidentalis leafy twig, vaccinia virus strain new york city board, gonorrheal urethral secretion human,sodium chloride, nerium oleander leaf,cicuta virosa root, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50114-5324
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]  in 1.1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]  in 1.1 mL
    VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN (UNII: 4SV59689SK) (VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN - UNII:4SV59689SK) VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN8 [hp_X]  in 1.1 mL
    BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND10 [hp_X]  in 1.1 mL
    SCABIES LESION LYSATE (HUMAN) (UNII: 5UAU16Z1U4) (SCABIES LESION LYSATE (HUMAN) - UNII:5UAU16Z1U4) SCABIES LESION LYSATE (HUMAN)10 [hp_X]  in 1.1 mL
    GONORRHEAL URETHRAL SECRETION HUMAN (UNII: 9BZG9E3I8F) (GONORRHEAL URETHRAL SECRETION HUMAN - UNII:9BZG9E3I8F) GONORRHEAL URETHRAL SECRETION HUMAN12 [hp_X]  in 1.1 mL
    NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) (NERIUM OLEANDER LEAF - UNII:7KV510R6H6) NERIUM OLEANDER LEAF4 [hp_X]  in 1.1 mL
    CICUTA VIROSA ROOT (UNII: YEA9P21S8N) (CICUTA VIROSA ROOT - UNII:YEA9P21S8N) CICUTA VIROSA ROOT5 [hp_X]  in 1.1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE5 [hp_X]  in 1.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50114-5324-610 in 1 CARTON
    11.1 mL in 1 AMPULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/1993
    Labeler - Heel Inc (102783016)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!