FDA Label for Psorinoheel

View Indications, Usage & Precautions

Psorinoheel Product Label

The following document was submitted to the FDA by the labeler of this product Heel Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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