Label: PLEO EX- candida albicans, candida parapsilosis, and penicillium roqueforti solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-1003-1 - 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 4, 2010
If you are a consumer or patient please visit this version.
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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 - 10 mL Bottle Label
Pleo® Ex DROPS 5X
Homeopathic Antifungal Medicine
Indications: For temporary relief of yeast infections
0.34 fl oz (10 mL)
Dosage: 5-10 drops, once daily, before mealtime. 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: 10
mL contain 3.33mL Candida albicans 5X, 3.33mL Candida parapsilosis 5X, 3.33mL
Penicillium roquefortii 5X in a base of purified water.
Rev. 04/2010
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INGREDIENTS AND APPEARANCE
PLEO EX
candida albicans, candida parapsilosis, and penicillium roqueforti solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-1003 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 10 mL candida parapsilosis (UNII: 0KZ676D44N) (candida parapsilosis - UNII:0KZ676D44N) candida parapsilosis 5 [hp_X] in 10 mL penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L) penicillium roqueforti 5 [hp_X] in 10 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-1003-1 1 in 1 CARTON 1 10 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)