Label: PLEO LEPTU- propionibacterium avidum 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 Arthritis Pain Relief Medicine

    10 SUPPOSITORIES

  • Indications

    For temporary relief of cramped or aching muscles.

  • ACTIVE INGREDIENT PER DOSE

    0.2 g Propionibacterium avidum 6X.

  • Inactive ingredients

    hydrogenated palm kernel glycerides, lactose.

  • DOSAGE

    1–3 times weekly, insert one suppository rectally at bedtime.

  • 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 taking 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

    Use this product only if imprinted inner blister pack is intact.

  • 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. 02/2003

  • PRINCIPAL DISPLAY PANEL - 10 Suppositories Carton

    Pleo™ Leptu
    SUPPOSITORIES 6X

    Homeopathic Arthritis
    Pain Relief Medicine

    Indications: For temporary
    relief of cramped or aching muscles.

    10 SUPPOSITORIES

    Principal Display Panel - 10 Suppositories Carton
  • INGREDIENTS AND APPEARANCE
    PLEO LEPTU 
    propionibacterium avidum suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1602
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    propionibacterium avidum (UNII: 29WQ1FER2K) (propionibacterium avidum - UNII:29WQ1FER2K) propionibacterium avidum6 [HP_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1602-11 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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