PLEO SAN ACNE- propionibacterium acnes solution/ drops

Pleo San Acne by

Drug Labeling and Warnings

Pleo San Acne by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

For temporary relief of acne.

INGREDIENTS

10 mL Propionibacterium acnes 6X in a base of purified water.

Tamper Evident

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

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 the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING

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

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

INGREDIENTS AND APPEARANCE

PLEO SAN ACNE 
propionibacterium acnes solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-3601
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
propionibacterium acnes (UNII: TRZ1AA965O) (propionibacterium acnes - UNII:TRZ1AA965O)	propionibacterium acnes	6 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-3601-1	1 in 1 CARTON
1		10 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		12/19/1996

Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)