Label: PLEO GINKGO- ginkgo biloba leaf 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 September 18, 2009

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Homeopathic Medicine

  • Indications

    For temporary relief of lack of appetite.

  • INGREDIENTS

    30 mL contains: Ginkgo biloba e follis sicc. 1X in a base of purified water, alcohol 66% by volume.

  • 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

    Take 10–15 drops, 3–5 times daily, unless otherwise recommended by your health care professional.

  • 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. 07/2007

  • PRINCIPAL DISPLAY PANEL - 30 mL Label

    Pleo™ Ginkgo DROPS 1X

    Homeopathic Medicine

    Indications: For temporary relief of lack of appetite.

    1 fl oz (30 mL)

    DOSAGE: 10–15 drops, 3–5 times daily. 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: 30 mL contains Ginkgo biloba e foliis sicc 1X in a base of purified water, alcohol
    66% by volume.
    Rev. 06/2009

    Principal Display Panel - 30 mL Label
  • PRINCIPAL DISPLAY PANEL - 30 mL box

    Pleo™ Ginkgo
    DROPS 1X

    Homeopathic
    Medicine

    lndications:
    For
    temporary relief
    of lack of appetite.

    1 fl oz
    (30 mL)

    Principal Display Panel - 30 mL box
  • INGREDIENTS AND APPEARANCE
    PLEO GINKGO 
    ginkgo biloba leaf solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-9001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ginkgo biloba leaf (UNII: 19FUJ2C58T) (ginkgo biloba leaf - UNII:19FUJ2C58T) ginkgo biloba leaf1 [HP_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-9001-31 in 1 CARTON
    130 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)