PLEO EX- candida albicans, candida parapsilosis, and penicillium roqueforti solution/ drops

Pleo Ex by

Drug Labeling and Warnings

Pleo Ex 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 temporary relief of yeast infections.

INGREDIENTS

10 mL contain 3.33mL Candida albicans 5X, 3.33mL Candida parapsilosis 5X and 3.33mL Penicillium roquefortii 5X 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, before mealtime.

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® Ex DROPS 5X

Homeopathic Antifungal Medicine

Indications: For temporary relief of yeast infections

0.34 fl oz (10 mL)

Dosage: 5-10 drops, once daily, before mealtime. 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 contain 3.33mL Candida albicans 5X, 3.33mL Candida parapsilosis 5X, 3.33mL
Penicillium roquefortii 5X in a base of purified water.

Rev. 04/2010

INGREDIENTS AND APPEARANCE

PLEO EX 
candida albicans, candida parapsilosis, and penicillium roqueforti solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-1003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
candida albicans (UNII: 4D7G21HDBC) (candida albicans - UNII:4D7G21HDBC)	candida albicans	5 [hp_X]  in 10 mL
candida parapsilosis (UNII: 0KZ676D44N) (candida parapsilosis - UNII:0KZ676D44N)	candida parapsilosis	5 [hp_X]  in 10 mL
penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L)	penicillium roqueforti	5 [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: 60681-1003-1	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)