Label: PLEO POLY T- mycobacterium microti immunoserum rabbit, mycobacterium bovis immunoserum rabbit, and streptococcus pyogenes immunoserum rabbit liquid

  • 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 8, 2010

If you are a consumer or patient please visit this version.

  • PURPOSE

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

  • Indications

    headache and arthritis/rheumatism pain.

  • 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: antitoxins and antigens 9X of Mycobacterium tuberculosis typus humanus, brevis, and bovinus; Diplococcus pneumoniae, Streptococcus mucosus.

    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 T DROPS 9X (applied topically)

    Homeopathic Medicine
    Indications: headache and arthritis/ rheumatism pain.
    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: antitoxins and antigens 9X of Mycobacterium tuberculosis typus humanus, brevis, and
    bovinus; Diplococcus pneumoniae, Streptococcus mucosus.
    R.ev. 05/2010

    PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PLEO POLY T 
    mycobacterium microti immunoserum rabbit, mycobacterium bovis immunoserum rabbit, and streptococcus pyogenes immunoserum rabbit liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    mycobacterium microti immunoserum rabbit (UNII: 3ZQN4Y38QI) (mycobacterium microti immunoserum rabbit - UNII:3ZQN4Y38QI) mycobacterium microti immunoserum rabbit9 [hp_X]  in 10 mL
    mycobacterium bovis immunoserum rabbit (UNII: NNW4543CRP) (mycobacterium bovis immunoserum rabbit - UNII:NNW4543CRP) mycobacterium bovis immunoserum rabbit9 [hp_X]  in 10 mL
    streptococcus pyogenes immunoserum rabbit (UNII: 726RS6QMS8) (streptococcus pyogenes immunoserum rabbit - UNII:726RS6QMS8) streptococcus pyogenes immunoserum rabbit9 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2810-11 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)