Pleo ® Ut DROPS 6X

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2012-03-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:03:43

Label at a glance#

ProductPleo Ut

Active ingredientbacillus subtilis

Label structure7 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

INDICATIONS & USAGE SECTION

Homeopathic Analgesic Medicine

0.17 fl oz
(5 mL)

DOSAGE

DOSAGE & ADMINISTRATION SECTION

1–3 times weekly 2–5 drops 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.

OTC - ACTIVE INGREDIENT SECTION

INGREDIENTS

INACTIVE INGREDIENT SECTION

5 mL Bacillus subtilis 6X, in a base of purified water.

Tamper Evident

SPL UNCLASSIFIED SECTION

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

SPL UNCLASSIFIED SECTION

Manufactured by:
SANUM-Kehlbeck
GmbH & Co. KG,
Hoya, Germany

Distributed by:
SANUM USA Corp.,
1465 Slater Road,
Ferndale, WA 98248

PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo^® Ut

DROPS 6X
Homeopathic
Analgesic
Medicine

The original
SANUM^®
brand remedies

Indications: For
temporary pain
relief of swollen
lymph glands.

0.17 fl oz
(5 mL)

Principal Display Panel - 5 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-5301-2	2019-11-13	C162847	48780-1	97449f38-c521-f6ea-e053-dbdaa90aa703	Pleo ® Ut DROPS 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-5301-2	Pleo Ut	1 in 1 CARTON	SOLUTION/ DROPS	1		2
60681-5301-2	Pleo Ut	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-5301	PLEO UT (BACILLUS SUBTILIS) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]	2	Legacy NDC, 2 package rows	20120413_50d6865b-689a-4f81-b464-08423096f31a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
bacillus subtilis	ACTIVE INGREDIENT	8CF93KW41W	2
bacillus subtilis	ACTIVE MOIETY	8CF93KW41W	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 Ut
bacillus subtilis
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-5301	60681-5301-2

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
bacillus subtilis	8CF93KW41W	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
f8f9ef39-0eb5-4596-bd05-4b8b37facc3b			50d6865b-689a-4f81-b464-08423096f31a	2012-03-09	Warnings	Exact identifier spl id: f8f9ef39-0eb5-4596-bd05-4b8b37facc3b spl set id: 50d6865b-689a-4f81-b464-08423096f31a

Reported adverse events (FAERS/openFDA)#

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