PLEO ORYZAE- aspergillus flavus var. oryzae solution/ drops 
Sanum Kehlbeck GmbH & Co. KG

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.

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Pleo® Oryzae
DROPS 6X

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.

Protect fom light and heat.

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

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label
PLEO ORYZAE 
aspergillus flavus var. oryzae solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspergillus flavus var. oryzae (UNII: Q6Z8UK5R3G) (aspergillus flavus var. oryzae - UNII:Q6Z8UK5R3G) aspergillus flavus var. oryzae6 [hp_X]  in 10 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-0021-11 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic06/15/2010
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 6/2010
Document Id: 15f8962a-0abe-42cf-9766-15d8508ba34d
Set id: 4870f541-5926-4f8a-97da-a9e2fe0a5c1a
Version: 1
Effective Time: 20100604
 
Sanum Kehlbeck GmbH & Co. KG