Label: PLEO SAN PROT- proteus vulgaris 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 October 30, 2013

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  • PURPOSE

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

  • Indications

    For temporary relief of otitis and chronic indigestion.

  • INGREDIENTS

    10 mL Proteus vulgaris 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

    1-2 × daily 5-10 drops.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner. As with any other drugs, 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 from 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

    Rev. 12/2005

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    Pleo® San

    PROT
    DROPS 6X

    Homeopathic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications:
    For temporary
    relief of otitis
    and chronic
    indigestion.

    0.34 fl oz
    (10 mL)

    Principal Display Panel - 10 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PLEO SAN PROT 
    proteus vulgaris solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1244
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    proteus vulgaris (UNII: 11T9HCO30O) (proteus vulgaris - UNII:11T9HCO30O) proteus vulgaris6 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1244-11 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic09/19/1997
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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