Pleo™ San ACNE DROPS 6X

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2011-08-01
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:03:17

Label at a glance#

ProductPleo San Acne

Active ingredientpropionibacterium acnes

Label structure9 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For temporary relief of acne.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

10 mL Propionibacterium acnes 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 or if imprinted security strip on carton is torn.

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

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

Manufactured By:
Sanum-Kehlbeck,
GmbH & Co. KG

Rev. 12/2007

PRINCIPAL DISPLAY PANEL - 10 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ San ACNE DROPS 6X

Homeopathic Medicine

Indications: For temporary relief of acne.

0.34 fl oz (10 mL)

DOSAGE: 1–2 × daily 5–10 drops. 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 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 Propionibacterium acnes
6X in a base of purified water.
Rev. 06/2009

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-3601-1	2019-10-29	C162847	48780-1	960f7f55-d826-8e05-e053-dbdaa90a074a	Pleo™ San ACNE DROPS 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-3601-1	Pleo San Acne	1 in 1 CARTON	SOLUTION/ DROPS	1		2
60681-3601-1	Pleo San Acne	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-3601	PLEO SAN ACNE (PROPIONIBACTERIUM ACNES) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]	2	Legacy NDC, 2 package rows	20110830_4389d5e9-0b49-4319-876e-cd0f6b7327c3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
propionibacterium acnes	ACTIVE INGREDIENT	TRZ1AA965O	2
propionibacterium acnes	ACTIVE MOIETY	TRZ1AA965O	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

Pleo San Acne
propionibacterium acnes
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-3601	60681-3601-1

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
Name	UNII	Kind
propionibacterium acnes	TRZ1AA965O	ACTIB
water	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cb472270-9e6f-49a8-b63b-ea0c803b2092			4389d5e9-0b49-4319-876e-cd0f6b7327c3	2011-08-01	Warnings	Exact identifier spl id: cb472270-9e6f-49a8-b63b-ea0c803b2092 spl set id: 4389d5e9-0b49-4319-876e-cd0f6b7327c3

Reported adverse events (FAERS/openFDA)#

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