Pleo Ex

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2009-10-13
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:53

Label at a glance#

ProductPleo Ex

Active ingredientcandida albicans, candida parapsilosis, penicillium roqueforti

Label structure10 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Antifungal Medicine

10 SUPPOSITORIES

Indications

INDICATIONS & USAGE SECTION

For temporary relief of yeast infections.

ACTIVE INGREDIENTS PER DOSE

OTC - ACTIVE INGREDIENT SECTION

0.067 g Candida albicans 3X, 0.067 g Candida parapsilosis 3X, 0.067 g Penicillium roquefortii 3X.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

hydrogenated palm kernel glycerides, lactose.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Once daily, insert one suppository rectally at bedtime.

WARNING

WARNINGS SECTION

If symptoms persist more than a few days, contact a licensed practitioner. As with other drugs, 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 other medications out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

OTC - DO NOT USE SECTION

Do not use this product if imprinted inner plastic shell is broken or if imprinted security strip on carton package 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. 12/2007

PRINCIPAL DISPLAY PANEL - 10 Suppositories Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Ex
SUPPOSITORIES 3X

Homeopathic Antifungal Medicine

Indications: For temporary
relief of yeast infections.

ORIGINAL ENDERLEIN

10 SUPPOSITORIES

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-1001-1	2019-10-21	C162847	48780-1	956f9ecf-dcd7-621f-e053-dbdaa90a74ad	Pleo™ Ex SUPPOSITORIES 3X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-1001-1	Pleo Ex	1 in 1 CARTON	SUPPOSITORY	1		1
60681-1001-1	Pleo Ex	10 in 1 DOSE PACK	SUPPOSITORY	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-1001	PLEO EX (CANDIDA ALBICANS, CANDIDA PARAPSILOSIS AND PENICILLIUM ROQUEFORTI) SUPPOSITORY [SANUM KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 2 package rows	20110113_900fcf78-f93a-425b-ab0a-0b9e476ccc4c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
candida albicans	ACTIVE INGREDIENT	4D7G21HDBC	1
candida parapsilosis	ACTIVE INGREDIENT	0KZ676D44N	1
penicillium roqueforti	ACTIVE INGREDIENT	7ORP6R724L	1
candida albicans	ACTIVE MOIETY	4D7G21HDBC	1
candida parapsilosis	ACTIVE MOIETY	0KZ676D44N	1
penicillium roqueforti	ACTIVE MOIETY	7ORP6R724L	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Pleo Ex
candida albicans, candida parapsilosis and penicillium roqueforti
candida albicans
candida parapsilosis
penicillium roqueforti
lactose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-1001	60681-1001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
candida albicans	4D7G21HDBC	ACTIB
candida parapsilosis	0KZ676D44N	ACTIB
penicillium roqueforti	7ORP6R724L	ACTIB
lactose	J2B2A4N98G	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
lactose	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates

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
0f11b256-9f93-4f77-87e8-a8bab35dd15b			900fcf78-f93a-425b-ab0a-0b9e476ccc4c	2009-10-13	Warnings	Exact identifier spl id: 0f11b256-9f93-4f77-87e8-a8bab35dd15b spl set id: 900fcf78-f93a-425b-ab0a-0b9e476ccc4c

Reported adverse events (FAERS/openFDA)#

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