Label: PLEO EX- candida albicans, candida parapsilosis and penicillium roqueforti 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 Antifungal Medicine

    10 SUPPOSITORIES

  • Indications

    For temporary relief of yeast infections.

  • ACTIVE INGREDIENTS PER DOSE

    0.067 g Candida albicans 3X, 0.067 g Candida parapsilosis 3X, 0.067 g Penicillium roquefortii 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 other drugs, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

    Keep this and all other medications out of the reach of children. In case of accidental ingestion, 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 plastic shell is broken or if imprinted security strip on carton package 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. 12/2007

  • PRINCIPAL DISPLAY PANEL - 10 Suppositories Carton

    Pleo™ Ex
    SUPPOSITORIES 3X

    Homeopathic Antifungal Medicine

    Indications: For temporary
    relief of yeast infections.

    ORIGINAL ENDERLEIN

    10 SUPPOSITORIES

    Principal Display Panel - 10 Suppositories Carton
  • INGREDIENTS AND APPEARANCE
    PLEO EX 
    candida albicans, candida parapsilosis and penicillium roqueforti suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1001
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    candida albicans (UNII: 4D7G21HDBC) (candida albicans - UNII:4D7G21HDBC) candida albicans3 [HP_X]
    candida parapsilosis (UNII: 0KZ676D44N) (candida parapsilosis - UNII:0KZ676D44N) candida parapsilosis3 [HP_X]
    penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L) penicillium roqueforti3 [HP_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1001-11 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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