PLEO NIG- aspergillus niger var. niger 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® Nig
DROPS 5X

Homeopathic Antipruritic Medicine

Indications

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

INGREDIENTS

10 mL Aspergillus niger 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 other 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.

Made in Germany

Manufactured by:
SANUM-Kehlbeck
GmbH & Co. KG,
Hoya, Germany

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

Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 10 mL Label

Pleo™ Nig DROPS 5X

Homeopathic Antipruritic Medicine

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

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 Aspergillus niger
5X in a base of purified water.
Rev. 06/2009

Principal Display Panel - 10 mL Label

PRINCIPAL DISPLAY PANEL - 10 mL Box

Pleo® Nig
DROPS 5X

Homeopathic
Antipruritic
Medicine

The original
SANUM
brand remedies

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

ORIGINAL ENDERLEIN

0.34 fl oz
(10 mL)

Principal Display Panel - 10 mL Box
PLEO NIG 
aspergillus niger var. niger solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2101
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]  in 10 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-2101-11 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic03/19/1996
Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133)

Revised: 9/2009
Document Id: f6b1a16f-a6d4-4084-8fb9-8dc6ad956722
Set id: 8e64452f-1727-4830-8e66-d094ac363846
Version: 1
Effective Time: 20090921
 
Sanum-Kehlbeck GmbH & Co. KG