PLEO EX- candida albicans, candida parapsilosis and penicillium roqueforti liquid

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

Oral Homeopathic Medicine

10 doses, each 1 mL
(.03 fl oz)

INDICATIONS

For temporary relief of yeast infections.

DIRECTIONS FOR USE

Snap off top portion of sipping container. Insert glass sipping straw.

DOSAGE

1 SIP, twice weekly.

INGREDIENTS

1 mL contains Candida albicans 5X, Candida parapsilosis 5X, Penicillium roquefortii 5X in a base of purified saline solution.

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.

STORAGE AND HANDLING

Protect from light and heat.

Tamper Evident

Do not use this product if the glass vial is broken or if imprinted security strip on carton is torn.

SPL UNCLASSIFIED SECTION

Made in Germany

Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248

Manufactured By:
Sanum-Kehlbeck GmbH & Co. KG

Rev. 10/2002

PRINCIPAL DISPLAY PANEL - 1 mL Carton

1005-1

Pleo™ Ex
PORTABLE SIPS 5X

Oral Homeopathic Medicine

INDICATIONS: For temporary relief of
yeast infections.

DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.

DOSAGE: 1 SIP, twice weekly.

INGREDIENTS: 1 mL contains Candida
albicans 5X, Candida parapsilosis 5X,
Penicillium roquefortii 5X in a base of pu-
rified saline solution.

ORIGINAL ENDERLEIN

convenient, disposable
single dose containers

10 doses, each 1 mL
(.03 fl oz)

Rev. 10/2002

INGREDIENTS AND APPEARANCE

PLEO EX 
candida albicans, candida parapsilosis and penicillium roqueforti liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-1005
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 1 mL
candida parapsilosis (UNII: 0KZ676D44N) (candida parapsilosis - UNII:0KZ676D44N)	candida parapsilosis	5 [HP_X]  in 1 mL
penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L)	penicillium roqueforti	5 [HP_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium chloride (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-1005-1	10 in 1 CARTON
1		1 mL in 1 VIAL, GLASS
2	NDC: 60681-1005-2	50 in 1 CARTON
2		1 mL in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		01/19/1998

Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)