Label: PLEO EX- candida albicans, candida parapsilosis and penicillium roqueforti liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-1005-1, 60681-1005-2 - 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 October 16, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- INDICATIONS
- DIRECTIONS FOR USE
- DOSAGE
- INGREDIENTS
- WARNING
- STORAGE AND HANDLING
- Tamper Evident
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 1 mL Carton
1005-1
Pleo™ Ex
PORTABLE SIPS 5XOral Homeopathic Medicine
INDICATIONS: For temporary relief of
yeast infections.DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.DOSAGE: 1 SIP, twice weekly.
INGREDIENTS: 1 mL contains Candida
albicans 5X, Candida parapsilosis 5X,
Penicillium roquefortii 5X in a base of pu-
rified saline solution.ORIGINAL ENDERLEIN
convenient, disposable
single dose containers10 doses, each 1 mL
(.03 fl oz)Rev. 10/2002
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INGREDIENTS AND APPEARANCE
PLEO EX
candida albicans, candida parapsilosis and penicillium roqueforti liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-1005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength candida albicans (UNII: 4D7G21HDBC) (candida albicans - UNII:4D7G21HDBC) candida albicans 5 [HP_X] in 1 mL candida parapsilosis (UNII: 0KZ676D44N) (candida parapsilosis - UNII:0KZ676D44N) candida parapsilosis 5 [HP_X] in 1 mL penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L) penicillium roqueforti 5 [HP_X] in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sodium chloride (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-1005-1 10 in 1 CARTON 1 1 mL in 1 VIAL, GLASS 2 NDC:60681-1005-2 50 in 1 CARTON 2 1 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 01/19/1998 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)