PLEO SELENE- sodium selenite solution/ drops

Pleo Selene by

Drug Labeling and Warnings

Pleo Selene 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 Medicine

1 fl oz (30 mL)

Indications

For general digestive support and following dental amalgam removal.

INGREDIENTS

30 mL contain 2.4 mL Sodium selenite 4X 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

5 drops, 3-4 x daily.

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

PRINCIPAL DISPLAY PANEL - 30 mL Carton

Pleo® Selene DROPS 4X

Homeopathic Medicine

Indications: For general digestive support and following dental amalgam removal

1 fl oz (30 mL)

Dosage: 5 drops, 3-4 x daily. 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 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. TAMPER
EVIDENT: Do not use this product if tamper-evident seal on base of bottle cap is missing or
broken. INGREDIENTS: 30 mL contain 2.4mL Sodium selenite 4X in a base of purified water
and alcohol 20% by volume.

Rev. 04/2010

INGREDIENTS AND APPEARANCE

PLEO SELENE 
sodium selenite solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-0901
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sodium selenite (UNII: HIW548RQ3W) (selenium - UNII:H6241UJ22B)	sodium selenite	4 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-0901-3	1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		06/15/2010

Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)