PLEO EX- candida albicans, candida parapsilosis, and penicillium roqueforti 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® Ex
DROPS 5X

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.

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® 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

Principal Display Panel - 10 mL Bottle Label
PLEO EX 
candida albicans, candida parapsilosis, and penicillium roqueforti solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
candida albicans (UNII: 4D7G21HDBC) (candida albicans - UNII:4D7G21HDBC) candida albicans5 [hp_X]  in 10 mL
candida parapsilosis (UNII: 0KZ676D44N) (candida parapsilosis - UNII:0KZ676D44N) candida parapsilosis5 [hp_X]  in 10 mL
penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L) penicillium roqueforti5 [hp_X]  in 10 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-1003-11 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: 5ac916ec-8252-4e53-8009-3cfb42347074
Set id: 837a1242-ad56-43b7-99b5-7859b265c9df
Version: 1
Effective Time: 20100604
 
Sanum Kehlbeck GmbH & Co. KG