PLEO CHELATE- magnesium sulfate, potassium chloride and sodium chloride solution/ drops

Pleo Chelate by

Drug Labeling and Warnings

Pleo Chelate by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

PLEO CHELATE 
magnesium sulfate, potassium chloride and sodium chloride solution/ drops

Product 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)