OTC - PURPOSE SECTION
Homeopathic Medicine
0.34 fl oz
(10 mL)
Pleo ® Poly E 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 E
Active ingredienttreponema pallidum immunoserum rabbit
Label structure8 sections
Label contents#
Full prescribing information#
Indications
to reduce minor inflammation.
DOSAGE
Unless otherwise prescribed, apply 5-10 drops into the bend of the elbow and rub in three times daily.
WARNING
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
10 mL aqueous dilution contains: antigens 9X of Treponema pallidum.
INACTIVE INGREDIENT SECTION
Inactive Ingredient water
Tamper Evident
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
Pleo® Poly E DROPS 9X (applied topically)
Homeopathic Medicine
Indications: to reduce minor inflammation.
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: antigens 9X of Treponema pallidum.
Rev. 05/2010
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 60681-2804-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-ce63-8e05-e053-dbdaa90a074a | Pleo ® Poly E DROPS 9X |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60681-2804-1 | Pleo Poly E | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 1 | |
| 60681-2804-1 | Pleo Poly E | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60681-2804 | PLEO POLY E (TREPONEMA PALLIDUM IMMUNOSERUM RABBIT) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG] | 1 | Legacy NDC, 2 package rows | 20101023_9d0a4fe5-d663-4324-9eb0-258b595713e8.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| treponema pallidum immunoserum rabbit | ACTIVE INGREDIENT | X6IVG15P6X | 1 | |
| treponema pallidum immunoserum rabbit | ACTIVE MOIETY | X6IVG15P6X | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Pleo Poly E
- treponema pallidum immunoserum rabbit
- water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60681-2804 | 60681-2804-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| treponema pallidum immunoserum rabbit | X6IVG15P6X | ACTIB |
| water | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 89d0830d-c768-4526-a4ae-7654c9e00cb6 | 9d0a4fe5-d663-4324-9eb0-258b595713e8 | 2010-10-08 | Warnings | 89d0830d-c768-4526-a4ae-7654c9e00cb6 9d0a4fe5-d663-4324-9eb0-258b595713e8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.