PLEO STOLO- penicillium brevicompactum solution/ drops

Pleo Stolo by

Drug Labeling and Warnings

Pleo Stolo 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 Anti-Inflammatory Medicine

0.34 fl oz
(10 mL)

INDICATIONS & USAGE

Indications

For nerve pain and inflammation.

INGREDIENTS

10 mL Penicillium brevicompactum 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.

DOSAGE

5-10 drops, once daily, before mealtime.

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 other 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 fom 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
Hoya, Germany

Rev. 03/2010

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

Pleo® Stolo DROPS 6X
Homeopathic Anti-Inflammatory Medicine

Indications: For nerve pain and inflammation.

0.34 fl oz (10 mL)

DOSAGE: 5-10 drops, once daily, before mealtime. 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 Penicillium
brevicompactum 6X in a base of purified water.

Rev. 04/2013

INGREDIENTS AND APPEARANCE

PLEO STOLO 
penicillium brevicompactum solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-0011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
penicillium brevicompactum (UNII: XXG5F7S4UR) (penicillium brevicompactum - UNII:XXG5F7S4UR)	penicillium brevicompactum	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: 60681-0011-1	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		06/15/2010

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