Abropernol Tablet

Manufacturer
Heel Inc
Effective date
2011-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:28

Label at a glance#

ProductAbropernol
Active ingredientARTEMISIA ABROTANUM FLOWERING TOP, PULSATILLA VULGARIS, CALCIUM FLUORIDE, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY, NITRIC ACID, KEROSENE
Label structure8 sections

Indications and uses

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

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.

Label contents#

Full prescribing information#

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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


WARNINGS

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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 INGREDIENT SECTION

Inactive ingredients: Lactose, Magnesium Stearate

PURPOSE

OTC - PURPOSE SECTION

Dermatitus, Minor skin irritations, Eczema, hyperhidrosis, Hyperkeratosis

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Abropernol Tablet.jpg
Abropernol Tablet.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50114-6134-22019-11-13C16284748780-197449f38-c7fa-f6ea-e053-dbdaa90aa703Abropernol Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50114-6134-2Abropernol30000 mg in 1 BOTTLETABLET300001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50114-6134ABROPERNOL (ARTEMISIA ABROTANUM FLOWERING TOP AND PULSATILLA VULGARIS AND CALCIUM FLUORIDE AND HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND NITRIC ACID AND KEROSENE ) TABLET [HEEL INC]1Legacy NDC, 1 package rows20111220_adfe12ec-eea8-43a2-a283-45b1f63204a8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODYACTIVE INGREDIENTDIF093I0371
ARTEMISIA ABROTANUM FLOWERING TOPACTIVE INGREDIENTQG07G580U01
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJS1
KEROSENEACTIVE INGREDIENT1C89KKC04E1
NITRIC ACIDACTIVE INGREDIENT411VRN1TV41
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODYACTIVE MOIETYDIF093I0371
ARTEMISIA ABROTANUM FLOWERING TOPACTIVE MOIETYQG07G580U01
CALCIUM FLUORIDEACTIVE MOIETYO3B55K4YKI1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJS1
KEROSENEACTIVE MOIETY1C89KKC04E1
NITRIC ACIDACTIVE MOIETY411VRN1TV41
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50114-613450114-6134-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0183c6a7-6195-451c-9eef-81d60c769d4fadfe12ec-eea8-43a2-a283-45b1f63204a82011-12-12WarningsExact identifier
spl id: 0183c6a7-6195-451c-9eef-81d60c769d4f
spl set id: adfe12ec-eea8-43a2-a283-45b1f63204a8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.