PLEO NIG- aspergillus niger var. niger suppository

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

10 SUPPOSITORIES

Indications

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

ACTIVE INGREDIENT PER DOSE

0.2 g Aspergillus niger 3X.

Inactive ingredients

hydrogenated palm kernel glycerides, lactose.

DOSAGE

Once daily, insert one suppository rectally 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 ingestion, 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 plastic shell is broken or if imprinted security strip on carton is torn.

SPL UNCLASSIFIED SECTION

Made in Germany.

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

Manufactured By:
Sanum-Kehlbeck
GmbH & Co. KG

Rev. 02/2008

PRINCIPAL DISPLAY PANEL - 10 Suppositories Carton

Pleo™ Nig
SUPPOSITORIES 3X

Homeopathic Antipruritic Medicine

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

ORIGINAL ENDERLEIN

10 SUPPOSITORIES

INGREDIENTS AND APPEARANCE

PLEO NIG 
aspergillus niger var. niger suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2104
Route of Administration	RECTAL

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	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
lactose (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-2104-1	1 in 1 CARTON
1		10 in 1 DOSE PACK

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)