FDA Label for Pleo Oryzae

View Indications, Usage & Precautions

Pleo Oryzae Product Label

The following document was submitted to the FDA by the labeler of this product Sanum Kehlbeck Gmbh & Co. Kg. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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


* Please review the disclaimer below.