Label: PLEO ORYZAE- aspergillus flavus var. oryzae solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-0021-1 - 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
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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® Oryzae DROPS 6X
Homeopathic Antifungal Medicine
Indications: For discomfort related to cold feet and hands.
0.34 fl oz (10 mL)
Dosage: 5-10 drops, once 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: 10 mL Aspergillus oryzae 6X
in a base of purified water.Rev. 04/2010
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INGREDIENTS AND APPEARANCE
PLEO ORYZAE
aspergillus flavus var. oryzae solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-0021 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aspergillus flavus var. oryzae (UNII: Q6Z8UK5R3G) (aspergillus flavus var. oryzae - UNII:Q6Z8UK5R3G) aspergillus flavus var. oryzae 6 [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:60681-0021-1 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)