PLEO SAN ACNE- propionibacterium acnes liquid

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

Oral Homeopathic Medicine

50 doses, each 1 mL
(.03 fl oz)

INDICATIONS

For temporary relief of acne.

DIRECTIONS FOR USE

Snap off top portion of sipping container. Insert glass sipping straw.

DOSAGE

1 SIP, every 1–3 days.

INGREDIENTS

1 mL contains Propionibacterium acnes 5X, in a base of purified saline solution.

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 the glass vial is broken or if imprinted security strip on carton is torn.

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. 12/97

PRINCIPAL DISPLAY PANEL - 1 mL Carton

3602-2

Pleo™ San ACNE
PORTABLE SIPS 5X

Oral Homeopathic Medicine

INDICATIONS: For temporary relief of acne.

DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.

DOSAGE: 1 SIP, every 1–3 days.

INGREDIENTS: 1 mL contains Propioni-
bacterium acnes 5X, in a base of purified
saline solution.

convenient, disposable
single dose containers

50 doses, each 1 mL
(.03 fl oz)

Rev. 12/97

INGREDIENTS AND APPEARANCE

PLEO SAN ACNE 
propionibacterium acnes liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-3602
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
propionibacterium acnes (UNII: TRZ1AA965O) (propionibacterium acnes - UNII:TRZ1AA965O)	propionibacterium acnes	5 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
sodium chloride (UNII: 451W47IQ8X)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-3602-1	10 in 1 CARTON
1		1 mL in 1 VIAL, GLASS
2	NDC: 60681-3602-2	50 in 1 CARTON
2		1 mL in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		01/19/1998

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