Indications
For general digestive support and following dental amalgam removal.
Pleo Selene
FDA Label NDC 60681-0901
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanum Kehlbeck Gmbh & Co. Kg for the product Pleo Selene (NDC 60681-0901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications, ingredients, tamper evident, dosage, warning, storage and handling, other, principal display panel - 30 ml carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Storage And Handling
Protect fom light and heat.
Other
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
Principal Display Panel (30 mL Carton)
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