Label: PLEO SAN ACNE- propionibacterium acnes 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 August 1, 2011

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

  • Indications

    For temporary relief of acne.

  • INGREDIENTS

    10 mL Propionibacterium acnes 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. 12/2007

  • PRINCIPAL DISPLAY PANEL - 10 mL Label

    Pleo™ San ACNE DROPS 6X

    Homeopathic Medicine

    Indications: For temporary relief of acne.

    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 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 Propionibacterium acnes
    6X in a base of purified water.
    Rev. 06/2009

    Principal Display Panel - 10 mL Label
  • INGREDIENTS AND APPEARANCE
    PLEO SAN ACNE 
    propionibacterium acnes solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-3601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    propionibacterium acnes (UNII: TRZ1AA965O) (propionibacterium acnes - UNII:TRZ1AA965O) propionibacterium acnes6 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-3601-11 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic12/19/1996
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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