Label: PLEO SAN ACNE- propionibacterium acnes 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 20, 2009

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  • SPL UNCLASSIFIED SECTION

    Oral Homeopathic Medicine

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

  • INDICATIONS

    For temporary relief of acne.

  • DIRECTIONS FOR USE

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

  • DOSAGE

    1 SIP, every 1–3 days.

  • INGREDIENTS

    1 mL contains Propionibacterium acnes 5X, 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 or if imprinted security strip on carton is torn.

  • 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. 12/97

  • PRINCIPAL DISPLAY PANEL - 1 mL Carton

    3602-2

    Pleo™ San ACNE
    PORTABLE SIPS 5X

    Oral Homeopathic Medicine

    INDICATIONS: For temporary relief of acne.

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

    DOSAGE: 1 SIP, every 1–3 days.

    INGREDIENTS: 1 mL contains Propioni-
    bacterium acnes 5X, in a base of purified
    saline solution.

    convenient, disposable
    single dose containers

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

    Rev. 12/97

    PRINCIPAL DISPLAY PANEL - 1 mL Carton
  • INGREDIENTS AND APPEARANCE
    PLEO SAN ACNE 
    propionibacterium acnes liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-3602
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    propionibacterium acnes (UNII: TRZ1AA965O) (propionibacterium acnes - UNII:TRZ1AA965O) propionibacterium acnes5 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium chloride (UNII: 451W47IQ8X)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-3602-110 in 1 CARTON
    11 mL in 1 VIAL, GLASS
    2NDC:60681-3602-250 in 1 CARTON
    21 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/19/1998
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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