Label: PLEO NIG- aspergillus niger var. niger solution/ drops

  • NDC Code(s): 60681-2101-1
  • Packager: Sanum-Kehlbeck GmbH & Co. KG
  • 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 September 21, 2009

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

  • SPL UNCLASSIFIED SECTION

    Homeopathic Antipruritic Medicine

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  • Indications

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

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  • INGREDIENTS

    10 mL Aspergillus niger 5X in a base of purified water.

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  • Tamper Evident

    Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

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  • DOSAGE

    5–10 drops, once daily, before mealtime.

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  • WARNING

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

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  • STORAGE AND HANDLING

    Protect from light and heat.

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  • SPL UNCLASSIFIED SECTION

    Made in Germany

    Manufactured by:
    SANUM-Kehlbeck
    GmbH & Co. KG,
    Hoya, Germany

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

    Rev. 06/2009

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  • PRINCIPAL DISPLAY PANEL - 10 mL Label

    Pleo™ Nig DROPS 5X

    Homeopathic Antipruritic Medicine

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

    0.34 fl oz (10 mL)

    DOSAGE: 5–10 drops, once daily, before mealtime. 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 using 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.
    Protect from light and heat. TAMPER EVIDENT: Do not use this product if tamper-evident
    seal on base of bottle cap is missing or broken. INGREDIENTS: 10 mL Aspergillus niger
    5X in a base of purified water.
    Rev. 06/2009

    Principal Display Panel - 10 mL Label
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  • PRINCIPAL DISPLAY PANEL - 10 mL Box

    Pleo® Nig
    DROPS 5X

    Homeopathic
    Antipruritic
    Medicine

    The original
    SANUM
    brand remedies

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

    ORIGINAL ENDERLEIN

    0.34 fl oz
    (10 mL)

    Principal Display Panel - 10 mL Box
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  • INGREDIENTS AND APPEARANCE
    PLEO NIG 
    aspergillus niger var. niger solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-2101
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    aspergillus niger var. niger (UNII: 9IOA40ANG6) (aspergillus niger var. niger - UNII:9IOA40ANG6) aspergillus niger var. niger 5 [HP_X]  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60681-2101-1 1 in 1 CARTON
    1 10 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved homeopathic 03/19/1996
    Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133)
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