Label: PLEO UT- bacillus subtilis 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 March 9, 2012

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  • PURPOSE

    Homeopathic Analgesic Medicine

    0.17 fl oz
    (5 mL)

  • DOSAGE

    1–3 times weekly 2–5 drops 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.

  • ACTIVE INGREDIENT

    INGREDIENTS

    5 mL Bacillus subtilis 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.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    SANUM-Kehlbeck
    GmbH & Co. KG,
    Hoya, Germany

    Distributed by:
    SANUM USA Corp.,
    1465 Slater Road,
    Ferndale, WA 98248

  • PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton

    Pleo® Ut

    DROPS 6X
    Homeopathic
    Analgesic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications: For
    temporary pain
    relief of swollen
    lymph glands.

    0.17 fl oz
    (5 mL)

    Principal Display Panel - 5 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PLEO UT 
    bacillus subtilis solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-5301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacillus subtilis (UNII: 8CF93KW41W) (bacillus subtilis - UNII:8CF93KW41W) bacillus subtilis6 [hp_X]  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-5301-21 in 1 CARTON
    15 mL in 1 BOTTLE, DROPPER
    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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