FDA.reportPublic FDA data

Pleo ® Ex DROPS 5X

Manufacturer
Sanum Kehlbeck GmbH & Co. KG
Effective date
2010-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:02:21

Label at a glance#

ProductPleo Ex
Active ingredientcandida albicans, candida parapsilosis, penicillium roqueforti
Label structure9 sections

Storage and handling

Protect fom light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Antifungal Medicine

0.34 fl oz
(10 mL)

Indications

INDICATIONS & USAGE SECTION

For temporary relief of yeast infections.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

10 mL contain 3.33mL Candida albicans 5X, 3.33mL Candida parapsilosis 5X and 3.33mL Penicillium roquefortii 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 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 other 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 fom 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
Hoya, Germany

Rev. 03/2010

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo® Ex DROPS 5X

Homeopathic Antifungal Medicine

Indications: For temporary relief of yeast infections

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 contain 3.33mL Candida albicans 5X, 3.33mL Candida parapsilosis 5X, 3.33mL
Penicillium roquefortii 5X in a base of purified water.

Rev. 04/2010

Principal Display Panel - 10 mL Bottle Label
Principal Display Panel - 10 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-1003-12019-10-21C16284748780-1956f9ecf-ca3e-621f-e053-dbdaa90a74adPleo ® Ex DROPS 5X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-1003-1Pleo Ex1 in 1 CARTONSOLUTION/ DROPS11
60681-1003-1Pleo Ex10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-1003PLEO EX (CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, AND PENICILLIUM ROQUEFORTI) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]1Legacy NDC, 2 package rows20100702_837a1242-ad56-43b7-99b5-7859b265c9df.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
candida albicansACTIVE INGREDIENT4D7G21HDBC1
candida parapsilosisACTIVE INGREDIENT0KZ676D44N1
penicillium roquefortiACTIVE INGREDIENT7ORP6R724L1
candida albicansACTIVE MOIETY4D7G21HDBC1
candida parapsilosisACTIVE MOIETY0KZ676D44N1
penicillium roquefortiACTIVE MOIETY7ORP6R724L1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60681-100360681-1003-1

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
NameUNIIKind
candida albicans4D7G21HDBCACTIB
candida parapsilosis0KZ676D44NACTIB
penicillium roqueforti7ORP6R724LACTIB
water059QF0KO0RIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5ac916ec-8252-4e53-8009-3cfb42347074837a1242-ad56-43b7-99b5-7859b265c9df2010-06-04WarningsExact identifier
spl id: 5ac916ec-8252-4e53-8009-3cfb42347074
spl set id: 837a1242-ad56-43b7-99b5-7859b265c9df

Reported adverse events (FAERS/openFDA)#

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