Label: PLEO CHELATE- magnesium sulfate, potassium chloride and sodium chloride 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 November 25, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic PREPARATION

    3.38 fl oz
    (100 mL)

    Indications

    To optimize body minerals

  • INGREDIENTS

    100g solution contains 4g magnesium sulphate 2X, 4g potassium chloride 2X, 1.6g sodium chloride 2X, sodium edetate, hydrogen peroxide, water, alcohol 3% 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

    Adults: take 15 drops twice daily under tongue or diluted in water, unless otherwise recommended by your health professional.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner. As with any other 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 - 100 mL Label

    Pleo™ Chelate
    HOMEOPATHIC
    PREPARATION

    Indications:
    To optimize body minerals

    3.38 fl oz
    (100 mL)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    PLEO CHELATE 
    magnesium sulfate, potassium chloride and sodium chloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-6100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    magnesium sulfate (UNII: DE08037SAB) (magnesium - UNII:I38ZP9992A) magnesium sulfate2 [hp_X]  in 100 mL
    potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152) potassium chloride2 [hp_X]  in 100 mL
    sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37) sodium chloride2 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    edetate sodium (UNII: MP1J8420LU)  
    hydrogen peroxide (UNII: BBX060AN9V)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-6100-11 in 1 CARTON
    1100 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic12/31/1996
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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