FDA.reportPublic FDA data

Pleo ® Poly R DROPS 9X

Manufacturer
Sanum Kehlbeck GmbH & Co. KG
Effective date
2010-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:02:41

Label at a glance#

ProductPleo Poly R
Active ingredientmycobacterium bovis immunoserum rabbit, mycobacterium microti immunoserum rabbit, streptococcus pyogenes immunoserum rabbit
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

INDICATIONS & USAGE SECTION

pain associated with rheumatism, gout and arthritis.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Unless otherwise prescribed, apply 5-10 drops into the bend of the elbow and rub in three times daily.

WARNING

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

If symptoms persist more than a few days, contact a licensed practitioner.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 other medications out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

OTC - WHEN USING SECTION

Protect from light and heat.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

10 mL aqueous dilution contains: antitoxins and antigens 9X of Mycobacterium tuberculosis typus bovinus and brevis, Streptococcus pyogenes.

INACTIVE INGREDIENT SECTION

Inactive Ingredient water

Tamper Evident

OTC - DO NOT USE SECTION

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

SPL UNCLASSIFIED SECTION

Made in Germany

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

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

Rev. 05/2010

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo® Poly R DROPS 9X (applied topically)

Homeopathic Medicine
Indications: pain associated with rheumatism, gout and arthritis.
0.34 fl oz (10 mL)

Dosage: Unless otherwise prescribed, 5-10 drops into the bend of the elbow and rub in three
times daily. 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
aqueous dilution contains: antitoxins and antigens 9X of Mycobacterium tuberculosis typus
bovinus and brevis, Streptococcus pyogenes.
Rev. 05/2010

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-2809-12019-10-29C16284748780-1960f7f55-cd67-8e05-e053-dbdaa90a074aPleo ® Poly R DROPS 9X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-2809-1Pleo Poly R10 mL in 1 BOTTLE, DROPPERLIQUID101
60681-2809-1Pleo Poly R1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-2809PLEO POLY R (MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT, MYCOBACTERIUM MICROTI IMMUNOSERUM RABBIT, AND STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT) LIQUID [SANUM KEHLBECK GMBH & CO. KG]1Legacy NDC, 2 package rows20101023_9dd901fa-4671-4b37-810e-573f0500967e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mycobacterium bovis immunoserum rabbitACTIVE INGREDIENTNNW4543CRP1
mycobacterium microti immunoserum rabbitACTIVE INGREDIENT3ZQN4Y38QI1
streptococcus pyogenes immunoserum rabbitACTIVE INGREDIENT726RS6QMS81
mycobacterium bovis immunoserum rabbitACTIVE MOIETYNNW4543CRP1
mycobacterium microti immunoserum rabbitACTIVE MOIETY3ZQN4Y38QI1
streptococcus pyogenes immunoserum rabbitACTIVE MOIETY726RS6QMS81
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60681-280960681-2809-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
mycobacterium bovis immunoserum rabbitNNW4543CRPACTIB
mycobacterium microti immunoserum rabbit3ZQN4Y38QIACTIB
streptococcus pyogenes immunoserum rabbit726RS6QMS8ACTIB
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
3ca665c4-c93c-4903-8223-f2bfc6cf9a239dd901fa-4671-4b37-810e-573f0500967e2010-10-08WarningsExact identifier
spl id: 3ca665c4-c93c-4903-8223-f2bfc6cf9a23
spl set id: 9dd901fa-4671-4b37-810e-573f0500967e

Reported adverse events (FAERS/openFDA)#

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