Label: PLEO SAN STAPH- staphylococcus aureus 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 November 11, 2011

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  • PURPOSE

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

  • Indications

    For temporary relief of acne, boils & abscesses.

  • INGREDIENTS

    10 mL Staphylococcus aureus 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 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.

  • 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. 04/2010

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    Pleo® San
    STAPH
    DROPS 6X

    Homeopathic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications: For
    temporary relief
    of acne, boils &
    abscesses.

    0.34 fl oz
    (10 mL)

    PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PLEO SAN STAPH 
    staphylococcus aureus solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1284
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    staphylococcus aureus (UNII: O478WX4004) (staphylococcus aureus - UNII:O478WX4004) staphylococcus aureus6 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1284-11 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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