Label: PLEO UT- bacillus subtilis 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 November 11, 2011

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  • PURPOSE

    Oral Homeopathic Medicine

    10 doses, each 1 mL
    (.03 fl oz)

  • INDICATIONS

    For temporary pain relief of swollen lymph glands.

  • DIRECTIONS FOR USE

    Snap off top portion of sipping container. Insert glass sipping straw.

  • DOSAGE

    1-2 x weekly 1 sip

  • INGREDIENTS

    1 mL contains Bacillus subtilis 4X, in a base of purified saline solution.

  • 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 the glass vial is broken.

  • SPL UNCLASSIFIED SECTION

    Made in Germany

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

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

    Rev. 12/2009

  • PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

    5305-1

    Pleo® Ut
    PORTABLE SIPS 4X

    Oral Homeopathic Medicine

    The original
    SANUM®
    brand remedies

    INDICATIONS: For temporary pain relief
    of swollen lymph glands.

    DIRECTIONS FOR USE: Snap off top
    portion of sipping container. Insert glass
    sipping straw.

    DOSAGE: 1-2 x weekly 1 sip

    INGREDIENTS: 1 mL contains Bacillus
    subtilis 4X, in a base of purified saline
    solution.

    Tamper Evident: Do not use this product
    if the glass vial is broken.

    convenient, disposable
    single dose containers

    10 doses, each 1 mL
    (.03 fl oz)

    Rev. 12/2009

    800IN4XSE10US912

    PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    PLEO UT 
    bacillus subtilis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-5305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacillus subtilis (UNII: 8CF93KW41W) (bacillus subtilis - UNII:8CF93KW41W) bacillus subtilis4 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-5305-110 in 1 CARTON
    11 mL in 1 VIAL, GLASS
    2NDC:60681-5305-250 in 1 CARTON
    21 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC03/19/1997
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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