Abropernol
FDA Label NDC 50114-6134

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Heel Inc for the product Abropernol (NDC 50114-6134). 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 keep out of reach of children, indications and usage, warnings, dosage and administration, active ingredient, inactive ingredient, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children.

Indications And Usage

For the temporary relief of:
  • Dermatitus
  • Minor skin irritations
  • Eczema, hyperhidrosis
  • Hyperkeratosis


Warnings

If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.

Dosage And Administration

Adults and children above 6 years: 1 tablet sublingually or dissolved completely in mouth 3 times daily or as directed by a physician.Infants and children to 6 years: 1/2 the adult dosage.

Active Ingredient

Each 300mg tablet contains as active ingredients: Abrotanum 4X, Pulsatilla 4X, Calcarea fluorica 12X 60 mg each; Hamamelis virginiana 4X, Agaricus muscarius 5X, Nitricum acidum 6X, Petroleum 6X 30 mg each.

Inactive Ingredient

Inactive ingredients: Lactose, Magnesium Stearate

Purpose

Dermatitus, Minor skin irritations, Eczema, hyperhidrosis, Hyperkeratosis

* Please review the disclaimer below.