Label: PLEO NIG- aspergillus niger var. niger suppository

  • 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 October 13, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Antipruritic Medicine

    10 SUPPOSITORIES

  • Indications

    For temporary relief of external itching and soreness in the urogenital region.

  • ACTIVE INGREDIENT PER DOSE

    0.2 g Aspergillus niger 3X.

  • Inactive ingredients

    hydrogenated palm kernel glycerides, lactose.

  • DOSAGE

    Once daily, insert one suppository rectally at bedtime.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before taking this product.

    Keep this and all medications out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Protect from light and heat.

    Tamper Evident

    Do not use this product if imprinted inner plastic shell is broken or if imprinted security strip on carton is torn.

  • SPL UNCLASSIFIED SECTION

    Made in Germany.

    Distributed by:
    SANUM USA Corp.
    1465 Slater Road
    Ferndale, WA 98248

    Manufactured By:
    Sanum-Kehlbeck
    GmbH & Co. KG

    Rev. 02/2008

  • PRINCIPAL DISPLAY PANEL - 10 Suppositories Carton

    Pleo™ Nig
    SUPPOSITORIES 3X

    Homeopathic Antipruritic Medicine

    Indications: For temporary
    relief of external itching and soreness
    in the urogenital region.

    ORIGINAL ENDERLEIN

    10 SUPPOSITORIES

    Principal Display Panel - 10 Suppositories Carton
  • INGREDIENTS AND APPEARANCE
    PLEO NIG 
    aspergillus niger var. niger suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2104
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspergillus Niger Var. Niger (UNII: 9IOA40ANG6) (Aspergillus Niger Var. Niger - UNII:9IOA40ANG6) Aspergillus Niger Var. Niger3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2104-11 in 1 CARTON
    110 in 1 DOSE PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic03/19/1996
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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