PLEO POLY OM- lactococcus lactis immunoserum rabbit, streptococcus pyogenes immunoserum rabbit, streptococcus viridans group immunoserum rabbit, staphylococcus epidermidis immunoserum rabbit, staphylococcus aureus immunoserum rabbit, streptococcus pneumoniae immunoserum rabbit, and mycobacterium bovis immunoserum rabbit solution/ drops

Pleo Poly Om by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURPOSE

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

skin conditions, such as warts and moles.

DOSAGE

Unless otherwise prescribed, apply 5-10 drops into the bend of the elbow and rub in three times daily.

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 ingestion, seek professional assistance or contact a Poison Control Center immediately.

Protect from light and heat.

INGREDIENTS

10 mL aqueous dilution contains: antitoxins and antigens 9X of Streptococcus lacticus, -pyogenes, -haemolyticus, - viridans; Staphylococcus albus, -pharyngis, -aureus; Diplococcus lanceolatus; Mycobacterium tuberculosis typus bovinus.

Inactive Ingredient water

Tamper Evident

Do not use this product if tamper-evident strip on base of bottle cap is missing or broken.

SPL UNCLASSIFIED SECTION

Made in Germany

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Manufactured by:
Sanum-Kehlbeck
GmbH & Co. KG
Hoya, Germany

Rev. 05/2010

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

Pleo® Poly Om DROPS 9X (applied topically)

Homeopathic Medicine

Indications: skin conditions, such as warts and moles.

0.34 fl oz (10 mL)

Dosage: Unless otherwise prescribed, 5-10 drops into the bend of the elbow and rub in three
times daily. 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
aqueous dilution contains: antitoxins and antigens 9X of Streptococcus lacticus, -pyogenes,
-haemolyticus, -viridans; Staphylococcus albus, -pharyngis, -aureus; Diplococcus lanceolatus;
Mycobacterium tuberculosis typus bovinus.
Rev. 05/2010

INGREDIENTS AND APPEARANCE

PLEO POLY OM 
lactococcus lactis immunoserum rabbit, streptococcus pyogenes immunoserum rabbit, streptococcus viridans group immunoserum rabbit, staphylococcus epidermidis immunoserum rabbit, staphylococcus aureus immunoserum rabbit, streptococcus pneumoniae immunoserum rabbit, and mycobacterium bovis immunoserum rabbit solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2808
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lactococcus lactis immunoserum rabbit (UNII: AST1Y049U1) (lactococcus lactis immunoserum rabbit - UNII:AST1Y049U1)	lactococcus lactis immunoserum rabbit	9 [hp_X]  in 10 mL
streptococcus pyogenes immunoserum rabbit (UNII: 726RS6QMS8) (streptococcus pyogenes immunoserum rabbit - UNII:726RS6QMS8)	streptococcus pyogenes immunoserum rabbit	9 [hp_X]  in 10 mL
streptococcus viridans group immunoserum rabbit (UNII: 4U4OEA495W) (streptococcus viridans group immunoserum rabbit - UNII:4U4OEA495W)	streptococcus viridans group immunoserum rabbit	9 [hp_X]  in 10 mL
staphylococcus epidermidis immunoserum rabbit (UNII: 8409DJA34Y) (staphylococcus epidermidis immunoserum rabbit - UNII:8409DJA34Y)	staphylococcus epidermidis immunoserum rabbit	9 [hp_X]  in 10 mL
staphylococcus aureus immunoserum rabbit (UNII: Q1G8TGQ05J) (staphylococcus aureus immunoserum rabbit - UNII:Q1G8TGQ05J)	staphylococcus aureus immunoserum rabbit	9 [hp_X]  in 10 mL
streptococcus pneumoniae immunoserum rabbit (UNII: IWJ46H2H5C) (streptococcus pneumoniae immunoserum rabbit - UNII:IWJ46H2H5C)	streptococcus pneumoniae immunoserum rabbit	9 [hp_X]  in 10 mL
mycobacterium bovis immunoserum rabbit (UNII: NNW4543CRP) (mycobacterium bovis immunoserum rabbit - UNII:NNW4543CRP)	mycobacterium bovis immunoserum rabbit	9 [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: 60681-2808-1	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		04/07/1999

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