Pleo ® Nig DROPS 5X

Manufacturer: Sanum-Kehlbeck GmbH & Co. KG
Effective date: 2009-09-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:53

Label at a glance#

ProductPleo Nig

Active ingredientaspergillus niger var. niger

Label structure10 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Antipruritic Medicine

Indications

INDICATIONS & USAGE SECTION

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

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

10 mL Aspergillus niger 5X in a base of purified water.

Tamper Evident

OTC - DO NOT USE SECTION

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

5–10 drops, once daily, before mealtime.

WARNING

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-2101-1	2019-10-21	C162847	48780-1	956f9ecf-c696-621f-e053-dbdaa90a74ad	Pleo ® Nig DROPS 5X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-2101-1	Pleo Nig	1 in 1 CARTON	SOLUTION/ DROPS	1		1
60681-2101-1	Pleo Nig	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-2101	PLEO NIG (ASPERGILLUS NIGER VAR. NIGER) SOLUTION/ DROPS [SANUM-KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 2 package rows	20110113_8e64452f-1727-4830-8e66-d094ac363846.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
aspergillus niger var. niger	ACTIVE INGREDIENT	9IOA40ANG6	1
aspergillus niger var. niger	ACTIVE MOIETY	9IOA40ANG6	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Pleo Nig
aspergillus niger var. niger
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-2101	60681-2101-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
aspergillus niger var. niger	9IOA40ANG6	ACTIB
water	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f6b1a16f-a6d4-4084-8fb9-8dc6ad956722			8e64452f-1727-4830-8e66-d094ac363846	2009-09-21	Warnings	Exact identifier spl id: f6b1a16f-a6d4-4084-8fb9-8dc6ad956722 spl set id: 8e64452f-1727-4830-8e66-d094ac363846

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.