PLEO ORYZAE- aspergillus flavus var. oryzae solution/ drops

Pleo Oryzae by

Drug Labeling and Warnings

Pleo Oryzae by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Homeopathic Antifungal Medicine

0.34 fl oz
(10 mL)

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.

Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING

Protect fom light and heat.

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

PLEO ORYZAE 
aspergillus flavus var. oryzae solution/ drops

Product 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)