Label: ABROPERNOL- 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

  • Category: HUMAN OTC 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 12, 2011

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

  • 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
  • PRINCIPAL DISPLAY PANEL

    Abropernol Tablet.jpg
  • INGREDIENTS AND APPEARANCE
    ABROPERNOL 
    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
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-6134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0) ARTEMISIA ABROTANUM FLOWERING TOP4 [hp_X]  in 300 mg
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS4 [hp_X]  in 300 mg
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (CALCIUM FLUORIDE - UNII:O3B55K4YKI) CALCIUM FLUORIDE12 [hp_X]  in 300 mg
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK4 [hp_X]  in 300 mg
    AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY5 [hp_X]  in 300 mg
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID6 [hp_X]  in 300 mg
    KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE6 [hp_X]  in 300 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Tablet) Size9mm
    FlavorImprint Code Heel
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50114-6134-230000 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/1984
    Labeler - Heel Inc (102783016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Heel Inc102783016manufacture