Label: PLEO NIG- aspergillus niger var. niger 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 October 12, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Antipruritic Medicine

    20 TABLETS

  • Indications

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

  • INGREDIENTS

    1 tablet contains 250 mg Aspergillus niger 5X in a base of lactose, potato starch, magnesium stearate.

  • DOSAGE

    1–3 tablets daily, either two hours before breakfast or at bedtime.

  • WARNING

    If symptoms persist more than a few days, contact your 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 overdose, seek professional assistance or contact a Poison Control Center immediately.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • Tamper Evident

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

    Lot #:

  • 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. 03/2008

  • PRINCIPAL DISPLAY PANEL - 20 Tablets Carton

    Pleo™ Nig
    TABLETS 5X

    Homeopathic
    Antipruritic Medicine

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

    ORIGINAL ENDERLEIN

    20 TABLETS

    Principal Display Panel - 20 Tablets Carton
  • INGREDIENTS AND APPEARANCE
    PLEO NIG 
    aspergillus niger var. niger tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    aspergillus niger var. niger (UNII: 9IOA40ANG6) (aspergillus niger var. niger - UNII:9IOA40ANG6) aspergillus niger var. niger5 [HP_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    Starch, Potato (UNII: 8I089SAH3T)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2102-11 in 1 CARTON
    120 in 1 BLISTER 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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