Pleo™ San PROT DROPS 6X

Manufacturer
Sanum Kehlbeck GmbH & Co. KG
Effective date
2013-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:05:09

Label at a glance#

ProductPleo San Prot
Active ingredientproteus vulgaris
Label structure9 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

INDICATIONS & USAGE SECTION

For temporary relief of otitis and chronic indigestion.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

10 mL Proteus vulgaris 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.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

1-2 × daily 5-10 drops.

WARNING

WARNINGS SECTION

If symptoms persist more than a few days, contact a licensed practitioner. As with any 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 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. 12/2005

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo® San

PROT
DROPS 6X

Homeopathic
Medicine

The original
SANUM®
brand remedies

Indications:
For temporary
relief of otitis
and chronic
indigestion.

0.34 fl oz
(10 mL)

Principal Display Panel - 10 mL Bottle Carton
Principal Display Panel - 10 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-1244-12019-11-27C16284748780-19855e2a2-4719-60a7-e053-dbdaa90a05bdPleo™ San PROT DROPS 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-1244-1Pleo San Prot10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
60681-1244-1Pleo San Prot1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-1244PLEO SAN PROT (PROTEUS VULGARIS) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]2Legacy NDC, 2 package rows20131106_118f5ab5-e2e0-466c-b395-85551bd3bbc3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
proteus vulgarisACTIVE INGREDIENT11T9HCO30O2
proteus vulgarisACTIVE MOIETY11T9HCO30O2
waterINACTIVE INGREDIENT059QF0KO0R2

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
60681-124460681-1244-1

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
proteus vulgaris11T9HCO30OACTIB
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
95351bd8-45c3-4a41-97ff-20345278b7a6118f5ab5-e2e0-466c-b395-85551bd3bbc32013-10-30WarningsExact identifier
spl id: 95351bd8-45c3-4a41-97ff-20345278b7a6
spl set id: 118f5ab5-e2e0-466c-b395-85551bd3bbc3

Reported adverse events (FAERS/openFDA)#

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