Other
Homeopathic Antifungal Medicine
0.34 fl oz
(10 mL)
Made in Germany
Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248
Manufactured by:
Sanum-Kehlbeck
GmbH & Co. KG
Hoya, Germany
Rev. 03/2010
Pleo Oryzae
FDA Label NDC 60681-0021
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 Oryzae (NDC 60681-0021). 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 other, indications, ingredients, tamper evident, dosage, warning, storage and handling, principal display panel - 10 ml bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications
For discomfort related to cold feet and hands.
Ingredients
10 mL Aspergillus oryzae 6X in a base of purified water.
Tamper Evident
Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.
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.
Storage And Handling
Protect fom light and heat.
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
Principal Display Panel (10 mL Bottle Label)
* Please review the disclaimer below.
