Label: PLEO ZINC- zinc gluconate 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 March 6, 2013

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Medicine

    1 fl oz
    (30 mL)

  • Indications

    For temporary relief of symptoms of acne and eczema.

  • INACTIVE INGREDIENT

    INGREDIENTS

    2.4 mL Zincum gluconicum 3X in a base of purified water and alcohol 20% by volume.

  • Tamper Evident

    Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

  • DOSAGE

    In case of acute conditions every half to one hour, not more than 6 × daily each 5 drops.

    In case of chronic forms 1-3 × daily 5 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 other 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 fom 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
    Hoya, Germany

    Rev. 03/2010

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    Pleo® Zinc
    DROPS 3X

    Homeopathic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications:
    For temporary relief of
    symptoms of acne and
    eczema.

    1 fl oz
    (30 mL)

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PLEO ZINC 
    zinc gluconate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-5502
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    zinc gluconate (UNII: U6WSN5SQ1Z) (zinc cation - UNII:13S1S8SF37) zinc gluconate3 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-5502-11 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic06/15/2010
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANUM KEHLBECK GmbH & Co. KG318386133MANUFACTURE(60681-5502)
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