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

  • Category: HUMAN OTC DRUG LABEL

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 8, 2009

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  • SPL UNCLASSIFIED SECTION

    Oral Homeopathic Medicine

    50 doses, each 1 mL
    (.03 fl oz)

  • INDICATIONS

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

  • DIRECTIONS FOR USE

    Snap off top portion of sipping container. Insert glass sipping straw.

  • DOSAGE

    1 SIP, twice weekly.

  • INGREDIENTS

    1 mL contains Aspergillus niger 6X, in a base of purified saline solution.

  • 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 the glass vial 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. 09/2002

  • PRINCIPAL DISPLAY PANEL - 1 mL Carton

    2107-2

    Pleo™ Nig
    PORTABLE SIPS 6X

    Oral Homeopathic Medicine

    INDICATIONS: For temporary relief of ex-
    ternal itching and soreness in the urogeni-
    tal region.

    DIRECTIONS FOR USE: Snap off top
    portion of sipping container. Insert glass
    sipping straw.

    DOSAGE: 1 SIP, twice weekly.

    INGREDIENTS: 1 mL contains Aspergil-
    lus niger 6X, in a base of purified saline
    solution.

    convenient, disposable
    single dose containers

    50 doses, each 1 mL
    (.03 fl oz)

    Rev. 09/2002

    PRINCIPAL DISPLAY PANEL - 1 mL Carton
  • INGREDIENTS AND APPEARANCE
    PLEO NIG 
    aspergillus niger var. niger solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2107
    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. niger6 [HP_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2107-110 in 1 CARTON
    11 mL in 1 VIAL, GLASS
    2NDC:60681-2107-250 in 1 CARTON
    21 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic03/19/1997
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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