FDA.reportPublic FDA data

Pleo™ Chelate DROPS 2X

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 02:03:00

Label at a glance#

ProductPleo Chelate
Active ingredientmagnesium sulfate, potassium chloride, sodium chloride
Label structure8 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic PREPARATION

3.38 fl oz
(100 mL)

Indications

INDICATIONS & USAGE SECTION

To optimize body minerals

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

100g solution contains 4g magnesium sulphate 2X, 4g potassium chloride 2X, 1.6g sodium chloride 2X, sodium edetate, hydrogen peroxide, water, alcohol 3% by volume.

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 or if imprinted security strip on carton is torn.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Adults: take 15 drops twice daily under tongue or diluted in water, unless otherwise recommended by your health professional.

WARNING

WARNINGS SECTION

If symptoms persist more than a few days, contact a licensed practitioner. As with any other 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. 12/2007

PRINCIPAL DISPLAY PANEL - 100 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Chelate
HOMEOPATHIC
PREPARATION

Indications:
To optimize body minerals

3.38 fl oz
(100 mL)

Principal Display Panel
Principal Display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-6100-12019-10-21C16284748780-1956f9ecf-d52d-621f-e053-dbdaa90a74adPleo™ Chelate DROPS 2X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-6100-1Pleo Chelate1 in 1 CARTONSOLUTION/ DROPS12
60681-6100-1Pleo Chelate100 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-6100PLEO CHELATE (MAGNESIUM SULFATE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]2Legacy NDC, 2 package rows20110114_000886ff-2ed7-4dbb-af17-78bf96d10c1f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
magnesium sulfateACTIVE INGREDIENTDE08037SAB2
potassium chlorideACTIVE INGREDIENT660YQ98I102
sodium chlorideACTIVE INGREDIENT451W47IQ8X2
magnesiumACTIVE MOIETYI38ZP9992A2
potassium cationACTIVE MOIETY295O53K1522
sodium cationACTIVE MOIETYLYR4M0NH372
alcoholINACTIVE INGREDIENT3K9958V90M2
edetate sodiumINACTIVE INGREDIENTMP1J8420LU2
hydrogen peroxideINACTIVE INGREDIENTBBX060AN9V2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60681-610060681-6100-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
magnesium sulfateDE08037SABACTIB
potassium chloride660YQ98I10ACTIB
sodium chloride451W47IQ8XACTIB
water059QF0KO0RIACT
edetate sodiumMP1J8420LUIACT
hydrogen peroxideBBX060AN9VIACT
alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 74 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUCAPSULE / ORAL1 mgExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUINJECTION / INTRAVENOUS0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUINJECTION, SOLUTION / INTRAVENOUS0.04 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VSOLUTION / TOPICAL0.16 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUTABLET / ORAL5 mgExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
hydrogen peroxideHYDROGEN PEROXIDEBBX060AN9VTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
edetate sodiumEDETATE SODIUMMP1J8420LUINJECTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates

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
cb92989a-98b5-46d3-82e8-cbedde97d667000886ff-2ed7-4dbb-af17-78bf96d10c1f2009-11-25WarningsExact identifier
spl id: cb92989a-98b5-46d3-82e8-cbedde97d667
spl set id: 000886ff-2ed7-4dbb-af17-78bf96d10c1f

Reported adverse events (FAERS/openFDA)#

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