Label: PLEO ALB- candida albicans ointment

  • 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 14, 2009

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  • SPL UNCLASSIFIED SECTION

    for topical use only
    Homeopathic Antifungal Medicine

    1.05 oz (30g)

  • Tamper Evident

    Do not use this product if metal seal under the tube cap is missing or broken.

  • ACTIVE INGREDIENTS

    1 g ointment contains; 0,1 g candida albicans 3x.

  • INACTIVE INGREDIENTS

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

  • Indications

    For temporary relief of minor irritation, itching or soreness associated with Candida albicans yeast infections.

  • 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 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 ingestion, 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. 01/2004

  • PRINCIPAL DISPLAY PANEL - 30 g Ointment Carton

    Pleo™ Alb
    OINTMENT 3X

    for topical
    use only
    Homeopathic
    Antifungal
    Medicine

    Indications: For
    temporary relief of
    minor irritation,
    itching or soreness
    associated with
    Candida albicans
    yeast infections.

    ORIGINAL ENDERLEIN

    1.05 oz (30g)

    Principal Display Panel - 30 g Ointment Carton
  • INGREDIENTS AND APPEARANCE
    PLEO ALB 
    candida albicans ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    candida albicans (UNII: 4D7G21HDBC) (candida albicans - UNII:4D7G21HDBC) candida albicans3 [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:60681-0104-11 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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