PLEO NIG- aspergillus niger var. niger solution/ drops

Pleo Nig by

Drug Labeling and Warnings

Pleo Nig 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

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.

STORAGE AND HANDLING

Protect from light and heat.

SPL UNCLASSIFIED SECTION

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 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)

INGREDIENTS AND APPEARANCE

PLEO NIG 
aspergillus niger var. niger solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
aspergillus niger var. niger (UNII: 9IOA40ANG6) (aspergillus niger var. niger - UNII:9IOA40ANG6)	aspergillus niger var. niger	5 [HP_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-2101-1	1 in 1 CARTON
1		10 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		03/19/1996

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