Label: PLEO PEF- candida parapsilosis ointment

  • 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 14, 2009

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  • SPL UNCLASSIFIED SECTION

    for topical use only
    Homeopathic Antipruritic / External Analgesic Medicine

    1.05 oz (30g)

  • Indications

    For temporary relief of external anal itching and irritation.

  • DOSAGE

    Apply thinly on the affected area 1–3 times daily.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner. As with any 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 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 metal seal under the tube cap is missing or broken.

  • INGREDIENTS

    Active Ingredients

    1 g ointment contains; 0.1 g Candida parapsilosis 3X.

    Inactive Ingredients

    lactic acid, lanolin alcohol, glycerylmonostearate, propylene glycol, polyglyceryl-3, cocoate magnesium sulfate, water.

  • 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

  • PRINCIPAL DISPLAY PANEL - 30 g Ointment Carton

    Pleo® Pef
    OINTMENT 3X

    for topical
    use only
    Homeopathic
    Antipruritic /
    External Analgesic
    Medicine

    The original
    SANUM™
    brand remedies

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

    ORIGINAL ENDERLEIN

    1.05 oz (30g)

    Principal Display Panel - 30 g Ointment Carton
  • INGREDIENTS AND APPEARANCE
    PLEO PEF 
    candida parapsilosis ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    candida parapsilosis (UNII: 0KZ676D44N) (candida parapsilosis - UNII:0KZ676D44N) candida parapsilosis3 [HP_X]  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    glyceryl monostearate (UNII: 230OU9XXE4)  
    lactic acid (UNII: 33X04XA5AT)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2504-11 in 1 CARTON
    130 g in 1 TUBE
    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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