Label: PLEO SELENE- sodium selenite solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-0901-3 - Packager: Sanum Kehlbeck GmbH & Co. KG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 June 2, 2010
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Indications
- INGREDIENTS
- Tamper Evident
- DOSAGE
- WARNING
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
PLEO SELENE
sodium selenite solution/ dropsProduct 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)