Pleo ® San MYC DROPS 6X

Manufacturer
Sanum Kehlbeck GmbH & Co. KG
Effective date
2011-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:03:25

Label at a glance#

ProductPleo San MYC
Active ingredientmycobacterium bovis
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 dry and scaly skin.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

10 mL Mycobacterium bovis 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 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

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

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

Rev. 03/2010

PRINCIPAL DISPLAY PANEL - 10 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo® San
MYC
DROPS 6X

Homeopathic
Medicine

The original
SANUM®
brand remedies

Indications:
For temporary
relief of dry and
scaly skin.

0.34 fl oz
(10 mL)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-1204-12019-11-13C16284748780-197449f38-cce9-f6ea-e053-dbdaa90aa703Pleo ® San MYC DROPS 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-1204-1Pleo San MYC10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
60681-1204-1Pleo San MYC1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-1204PLEO SAN MYC (MYCOBACTERIUM BOVIS) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]3Legacy NDC, 2 package rows20111121_e4e8a009-7754-4fcd-b140-ede7d169d8e0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mycobacterium bovisACTIVE INGREDIENTXZQ806VFEO3
mycobacterium bovisACTIVE MOIETYXZQ806VFEO3
waterINACTIVE INGREDIENT059QF0KO0R3

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
60681-120460681-1204-1

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
mycobacterium bovisXZQ806VFEOACTIB
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
640c82c3-ca2b-4d63-a24b-9e5a222a5a76e4e8a009-7754-4fcd-b140-ede7d169d8e02011-11-09WarningsExact identifier
spl id: 640c82c3-ca2b-4d63-a24b-9e5a222a5a76
spl set id: e4e8a009-7754-4fcd-b140-ede7d169d8e0

Reported adverse events (FAERS/openFDA)#

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