Label: PLEO NIG- aspergillus niger var. niger capsule

  • 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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  • ACTIVE INGREDIENT

  • SPL UNCLASSIFIED SECTION

    Homeopathic Antipruritic Medicine

    20 CAPSULES

  • Indications

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

  • INGREDIENTS

    1 capsule contains 330 mg Aspergillus niger 4X.

  • Inactive ingredients

    Lactose, Capsule shells consist of Hypromellose (HPMC).

  • Tamper Evident

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

  • DOSAGE

    1–3 capsules daily, either before breakfast or 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 overdose, seek professional assistance or contact a Poison Control Center immediately.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • 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 Capsules Carton

    Pleo™ Nig
    CAPSULES 4X

    Homeopathic
    Antipruritic Medicine

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

    ORIGINAL ENDERLEIN

    20 CAPSULES

    Principal Display Panel - 20 Capsules Carton
  • INGREDIENTS AND APPEARANCE
    PLEO NIG 
    aspergillus niger var. niger capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2103
    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. niger4 [HP_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    hypromellose (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2103-11 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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