Label: PLEO POLY DX- streptococcus pneumoniae immunoserum rabbit and staphylococcus aureus immunoserum rabbit solution/ drops

  • 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 8, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • PURPOSE

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

  • Indications

    for minor focal oral infections.

  • DOSAGE

    Unless otherwise prescribed, apply 5-10 drops into the bend of the elbow and rub in three 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 other medications out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Protect from light and heat.

  • INGREDIENTS

    10 mL aqueous dilution contains: antigens 9X of Streptococcus lanceolatus, Staphylococcus aureus, Diplococcus pneumoniae..

    Inactive Ingredient water

  • Tamper Evident

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

  • 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. 05/2010

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

    Pleo® Poly Dx DROPS 9X (applied topically)

    Homeopathic Medicine
    Indications: for minor focal oral infections.
    0.34 fl oz (10 mL)

    Dosage: Unless otherwise prescribed, 5-10 drops into the bend of the elbow and rub in three
    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 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
    aqueous dilution contains: antigens 9X of Streptococcus lanceolatus, Staphylococcus aureus,
    Diplococcus pneumoniae.
    Rev. 05/2010

    Principal Display Panel  - 10 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PLEO POLY DX 
    streptococcus pneumoniae immunoserum rabbit and staphylococcus aureus immunoserum rabbit solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    streptococcus pneumoniae immunoserum rabbit (UNII: IWJ46H2H5C) (streptococcus pneumoniae immunoserum rabbit - UNII:IWJ46H2H5C) streptococcus pneumoniae immunoserum rabbit9 [hp_X]  in 10 mL
    staphylococcus aureus immunoserum rabbit (UNII: Q1G8TGQ05J) (staphylococcus aureus immunoserum rabbit - UNII:Q1G8TGQ05J) staphylococcus aureus immunoserum rabbit9 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2803-11 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/07/1999
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)