PLEO NIG- aspergillus niger var. niger tablet 
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™ Nig
TABLETS 5X

Homeopathic Antipruritic Medicine

20 TABLETS

Indications

For temporary relief of external itching and soreness in the urogenital region.

INGREDIENTS

1 tablet contains 250 mg Aspergillus niger 5X in a base of lactose, potato starch, magnesium stearate.

DOSAGE

1–3 tablets daily, either two hours before breakfast or at bedtime.

WARNING

If symptoms persist more than a few days, contact your licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before taking 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 imprinted inner blister pack is broken or if imprinted security strip on carton is torn.

Lot #:

Made in Germany.

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

Manufactured by:
Sanum-Kehlbeck
GmbH & Co. KG

Rev. 03/2008

PRINCIPAL DISPLAY PANEL - 20 Tablets Carton

Pleo™ Nig
TABLETS 5X

Homeopathic
Antipruritic Medicine

lndications: For temporary relief of
external itching and soreness in the
urogenital region.

ORIGINAL ENDERLEIN

20 TABLETS

Principal Display Panel - 20 Tablets Carton
PLEO NIG 
aspergillus niger var. niger tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspergillus niger var. niger (UNII: 9IOA40ANG6) (aspergillus niger var. niger - UNII:9IOA40ANG6) aspergillus niger var. niger5 [HP_X]
Inactive Ingredients
Ingredient NameStrength
lactose (UNII: J2B2A4N98G)  
Starch, Potato (UNII: 8I089SAH3T)  
Magnesium Stearate (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-2102-11 in 1 CARTON
120 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic03/19/1996
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 10/2009
Document Id: e5c16ad8-763d-4887-b2fd-e6e97f53fd23
Set id: 7efc76cd-31bb-42dc-9739-ed184b09e626
Version: 1
Effective Time: 20091012
 
Sanum Kehlbeck GmbH & Co. KG