Label: PLEO STOLO- penicillium brevicompactum 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 August 5, 2013

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Anti-Inflammatory Medicine

    0.34 fl oz
    (10 mL)

  • INDICATIONS & USAGE

    Indications

    For nerve pain and inflammation.

  • INGREDIENTS

    10 mL Penicillium brevicompactum 6X 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.

  • 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 other 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 fom 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
    Hoya, Germany

    Rev. 03/2010

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

    Pleo® Stolo DROPS 6X
    Homeopathic Anti-Inflammatory Medicine

    Indications: For nerve pain and inflammation.

    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 Penicillium
    brevicompactum 6X in a base of purified water.

    Rev. 04/2013

    PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PLEO STOLO 
    penicillium brevicompactum solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    penicillium brevicompactum (UNII: XXG5F7S4UR) (penicillium brevicompactum - UNII:XXG5F7S4UR) penicillium brevicompactum6 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-0011-11 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic06/15/2010
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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