Pleo Chelate: Homeopathic Product Information

PLEO CHELATE- magnesium sulfate, potassium chloride and sodium chloride solution/ drops
Sanum Kehlbeck GmbH & Co. KG

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.

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.

Protect from light and heat.

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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
magnesium sulfate (magnesium) magnesium sulfate 2 [hp_X] in 100 mL
potassium chloride (potassium cation) potassium chloride 2 [hp_X] in 100 mL
sodium chloride (sodium cation) sodium chloride 2 [hp_X] in 100 mL
Inactive Ingredients
Ingredient Name Strength
water
edetate sodium
hydrogen peroxide
alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60681-6100-1 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 100 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (60681-6100-1)
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)

Revised: 11/2009 Sanum Kehlbeck GmbH & Co. KG

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