Label: PLEO PEF- candida parapsilosis solution/ drops

  • 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 29, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Antifungal Medicine

  • Indications

    For temporary relief of external anal itching and irritation.

  • INGREDIENTS

    Contains 10 mL Candida parapsilosis 5X in a base of purified water.

  • Tamper Evident

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

  • 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.

  • 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. 02/2008

  • PRINCIPAL DISPLAY PANEL - 10 mL Label

    Pleo™ Pef DROPS 5X

    Homeopathic Antifungal Medicine

    Indications: For temporary relief of external anal itching and irritation.

    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 Candida parapsilosis
    5X in a base of purified water.
    Rev. 06/2009

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

    Pleo™ Pef
    DROPS 5X

    Homeopathic
    Antifungal
    Medicine

    Indications: For
    temporary relief
    of external anal
    itching and
    irritation.

    ORIGINAL ENDERLEIN

    0.34 fl oz
    (10 mL)

    Principal Display Panel - 10 mL Box
  • INGREDIENTS AND APPEARANCE
    PLEO PEF 
    candida parapsilosis solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2501
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDIDA PARAPSILOSIS (UNII: 0KZ676D44N) (CANDIDA PARAPSILOSIS - UNII:0KZ676D44N) CANDIDA PARAPSILOSIS5 [HP_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2501-11 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    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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