PLEO NIG- aspergillus niger var. niger capsule 
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
CAPSULES 4X

Homeopathic Antipruritic Medicine

20 CAPSULES

Indications

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

INGREDIENTS

1 capsule contains 330 mg Aspergillus niger 4X.

Inactive ingredients

Lactose, Capsule shells consist of Hypromellose (HPMC).

Tamper Evident

Do not use this product, if imprinted inner blister pack is broken or if imprinted security strip on carton is torn.

DOSAGE

1–3 capsules daily, either before breakfast or at bedtime.

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 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.

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 Capsules Carton

Pleo™ Nig
CAPSULES 4X

Homeopathic
Antipruritic Medicine

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

ORIGINAL ENDERLEIN

20 CAPSULES

Principal Display Panel - 20 Capsules Carton
PLEO NIG 
aspergillus niger var. niger capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2103
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. niger4 [HP_X]
Inactive Ingredients
Ingredient NameStrength
lactose (UNII: J2B2A4N98G)  
hypromellose (UNII: 3NXW29V3WO)  
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-2103-11 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: f9361bb9-2c5a-4983-8d8b-0ace0b71031b
Set id: 121d7b03-ec2b-4f5c-bf9e-ef0364196b8e
Version: 1
Effective Time: 20091012
 
Sanum Kehlbeck GmbH & Co. KG