Pleo™ Pef DROPS 5X

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2009-09-29
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:58

Label at a glance#

ProductPleo Pef

Active ingredientCANDIDA PARAPSILOSIS

Label structure10 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Antifungal Medicine

Indications

INDICATIONS & USAGE SECTION

For temporary relief of external anal itching and irritation.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Contains 10 mL Candida parapsilosis 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 or if imprinted security strip on carton is torn.

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 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

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 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Pef DROPS 5X

Homeopathic Antifungal Medicine

Indications: For temporary relief of external anal itching and irritation.

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 Candida parapsilosis
5X in a base of purified water.
Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 10 mL Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Pef
DROPS 5X

Homeopathic
Antifungal
Medicine

Indications: For
temporary relief
of external anal
itching and
irritation.

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
60681-2501-1	2019-10-21	C162847	48780-1	956f9ecf-d6cb-621f-e053-dbdaa90a74ad	Pleo™ Pef DROPS 5X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-2501-1	Pleo Pef	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		1
60681-2501-1	Pleo Pef	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-2501	PLEO PEF (CANDIDA PARAPSILOSIS) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 2 package rows	20110113_d9be316e-183c-410c-8238-34141bd1cf76.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CANDIDA PARAPSILOSIS	ACTIVE INGREDIENT	0KZ676D44N	1
CANDIDA PARAPSILOSIS	ACTIVE MOIETY	0KZ676D44N	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 Pef
CANDIDA PARAPSILOSIS
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-2501	60681-2501-1

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
CANDIDA PARAPSILOSIS	0KZ676D44N	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
a0bab26f-0b21-41dd-87c9-727e6a675f8c			d9be316e-183c-410c-8238-34141bd1cf76	2009-09-29	Warnings	Exact identifier spl id: a0bab26f-0b21-41dd-87c9-727e6a675f8c spl set id: d9be316e-183c-410c-8238-34141bd1cf76

Reported adverse events (FAERS/openFDA)#

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