The following Structured Product Label (SPL) was submitted to the FDA by Heel Inc for the product Psorinoheel (NDC 50114-5324). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indication and usage, dosage and administration, contraindications, warnings and precautions, adverse reactions, overdosage, clinical pharmacology, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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:
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
Psorinoheel® Oral Vials are contraindicated in patients with known hypersensitivity to Psorinoheel® or any of its ingredients.
Warnings and Precautions
None
No adverse events have been reported with a causal relationship Psorinoheel® Oral Vials.
Overdosage: No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions
Mechanism of Action
The exact mechanism of Psorinoheel®Oral Vials is not fully understood.
Pharmacodynamics
Not applicable for homeopathic medicinal products.
1 oral vial containing 1.1 ml solution for oral administration
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