Label: PLEO SAN BRUCEL- brucella melitensis 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 1, 2009

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

  • SPL UNCLASSIFIED SECTION

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

  • Indications

    For temporary relief of muscle aches.

  • INGREDIENTS

    10 mL Brucella melitensis 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 or if imprinted security strip on carton is torn.

  • 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.

  • 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. 10/2007

  • PRINCIPAL DISPLAY PANEL - 10 mL Label

    Pleo™ San BRUCEL DROPS 6X

    Homeopathic Medicine

    Indications: For temporary relief of muscle aches.

    0.34 fl oz (10 mL)

    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. TAMPER EVIDENT: Do not use this product if tamper-evident seal on
    base of bottle cap is missing or broken. INGREDIENTS: 10 mL Brucella melitensis 6X
    in a base of purified water.
    Rev. 06/2009

    Principal Display Panel 10 mL Label
  • INGREDIENTS AND APPEARANCE
    PLEO SAN BRUCEL 
    brucella melitensis solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    brucella melitensis (UNII: OQF85710LZ) (brucella melitensis - UNII:OQF85710LZ) brucella melitensis6 [HP_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1234-11 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic01/19/1998
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)