Label: PLEO CHELATE- magnesium sulfate, potassium chloride and sodium chloride solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-6100-1 - Packager: Sanum Kehlbeck GmbH & Co. KG
- 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 November 25, 2009
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- INGREDIENTS
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- PRINCIPAL DISPLAY PANEL - 100 mL Label
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INGREDIENTS AND APPEARANCE
PLEO CHELATE
magnesium sulfate, potassium chloride and sodium chloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-6100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength magnesium sulfate (UNII: DE08037SAB) (magnesium - UNII:I38ZP9992A) magnesium sulfate 2 [hp_X] in 100 mL potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152) potassium chloride 2 [hp_X] in 100 mL sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37) sodium chloride 2 [hp_X] in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) edetate sodium (UNII: MP1J8420LU) hydrogen peroxide (UNII: BBX060AN9V) alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-6100-1 1 in 1 CARTON 1 100 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 12/31/1996 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)