FDA.reportPublic FDA data

Pleo ® Ver DROPS 6X

Manufacturer
SANUM-KEHLBECK GMBH & CO KG
Effective date
2011-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:07

Label at a glance#

ProductPleo Ver
Active ingredientTrichophyton Verrucosum
Label structure9 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Homeopathic Antifungal Medicine

0.34 fl oz
(10 mL)

Indications

INDICATIONS & USAGE SECTION

For temporary relief of irritation, itching, and soreness caused by tinea corporis (ringworm), tinea cruris (jock itch) and tinea pedis (athlete's foot).

DOSAGE

DOSAGE & ADMINISTRATION SECTION

5-10 drops, once daily.

WARNING

WARNINGS SECTION

If symptoms persist more than a few days, contact a licensed practitioner.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 from light and heat.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

10 mL Trichophyton verrucosum 6X 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.

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. 10/2010

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo® Ver DROPS 6X

Homeopathic Antifungal Medicine

Indications: For temporary relief of irritation, itching, and soreness caused by tinea
corporis (ringworm), tinea cruris (jock itch) and tinea pedis (athlete's foot).

0.34 fl oz (10 mL)

Dosage: 5-10 drops, once daily. 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 Trichophyton verrucosum 6X in
a base of purified water.

Rev. 10/2010

Principal Display Panel
Principal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-5701-12019-10-29C16284748780-1960f7f55-c782-8e05-e053-dbdaa90a074aPleo ® Ver DROPS 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-5701-1Pleo Ver10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101
60681-5701-1Pleo Ver1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-5701PLEO VER (TRICHOPHYTON VERRUCOSUM) SOLUTION/ DROPS [SANUM-KEHLBECK GMBH & CO KG]1Legacy NDC, 2 package rows20110203_90172f41-74d8-4592-8737-3793f89df265.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Trichophyton VerrucosumACTIVE INGREDIENTJA74887EHM1
Trichophyton VerrucosumACTIVE MOIETYJA74887EHM1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60681-570160681-5701-1

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
NameUNIIKind
Trichophyton VerrucosumJA74887EHMACTIB
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
abab75e4-2a2b-4f80-83dd-1438222c78cf90172f41-74d8-4592-8737-3793f89df2652011-01-28WarningsExact identifier
spl id: abab75e4-2a2b-4f80-83dd-1438222c78cf
spl set id: 90172f41-74d8-4592-8737-3793f89df265

Reported adverse events (FAERS/openFDA)#

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