PLEO PIN- fomitopsis pinicola solution/ drops

Pleo Pin by

Drug Labeling and Warnings

Pleo Pin 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 Antipyretic Medicine

Indications

For temporary relief of fever.

INGREDIENTS

10 mL Fomitopsis pinicola e mycelio 5X 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

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.

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. 08/2007

PRINCIPAL DISPLAY PANEL - 10 mL Label

Pleo™ Pin DROPS 5X

Homeopathic Antipyretic Medicine

Indications: For temporary relief of fever.

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 Fomitopsis pinicola
e mycelio 5X in a base of purified water.
Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 10 mL Box

Pleo™ Pin
DROPS 5X

Homeopathic
Antipyretic
Medicine

Indications: For
temporary relief
of fever.

0.34 fl oz
(10 mL)

INGREDIENTS AND APPEARANCE

PLEO PIN 
fomitopsis pinicola solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2701
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOMITOPSIS PINICOLA (UNII: 30D02U2IRN) (FOMITOPSIS PINICOLA - UNII:30D02U2IRN)	FOMITOPSIS PINICOLA	5 [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: 60681-2701-1	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		03/19/1996

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