Pleo™ Usti DROPS 5X

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2009-11-25
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:03:01

Label at a glance#

ProductPleo Usti

Active ingredientustilago maydis

Label structure9 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

INDICATIONS & USAGE SECTION

For temporary relief of menopausal symptoms.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

10 mL Ustilago zeae e sporibus rec. 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 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. 08/2005

PRINCIPAL DISPLAY PANEL - 10 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Usti DROPS 5X

Homeopathic Medicine

Indications: For temporary relief of menopausal symptoms.

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 Ustilago zeae e
sporibus rec. 5X in a base of purified water.
Rev. 06/2009

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-5601-1	2019-10-21	C162847	48780-1	956f9ecf-d5a2-621f-e053-dbdaa90a74ad	Pleo™ Usti DROPS 5X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-5601-1	Pleo Usti	30 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	30		2
60681-5601-1	Pleo Usti	1 in 1 CARTON	SOLUTION/ DROPS	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-5601	PLEO USTI (USTILAGO MAYDIS) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]	2	Legacy NDC, 2 package rows	20110114_4c5bdb24-162f-4a6e-8d6f-c8be516ba9bb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ustilago maydis	ACTIVE INGREDIENT	4K7Z7K7SWG	2
ustilago maydis	ACTIVE MOIETY	4K7Z7K7SWG	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Pleo Usti
ustilago maydis
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-5601	60681-5601-1

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
ustilago maydis	4K7Z7K7SWG	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
7b103d01-a1ae-49ed-8698-46d8227a5bd8			4c5bdb24-162f-4a6e-8d6f-c8be516ba9bb	2009-11-25	Warnings	Exact identifier spl id: 7b103d01-a1ae-49ed-8698-46d8227a5bd8 spl set id: 4c5bdb24-162f-4a6e-8d6f-c8be516ba9bb

Reported adverse events (FAERS/openFDA)#

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