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 
Sanum Kehlbeck GmbH & Co. KG

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Pleo® Poly Om
DROPS 9X

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.

Made in Germany

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

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

Principal Display Panel - 10 mL Bottle Label
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2808
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
lactococcus lactis immunoserum rabbit (UNII: AST1Y049U1) (lactococcus lactis immunoserum rabbit - UNII:AST1Y049U1) lactococcus lactis immunoserum rabbit9 [hp_X]  in 10 mL
streptococcus pyogenes immunoserum rabbit (UNII: 726RS6QMS8) (streptococcus pyogenes immunoserum rabbit - UNII:726RS6QMS8) streptococcus pyogenes immunoserum rabbit9 [hp_X]  in 10 mL
streptococcus viridans group immunoserum rabbit (UNII: 4U4OEA495W) (streptococcus viridans group immunoserum rabbit - UNII:4U4OEA495W) streptococcus viridans group immunoserum rabbit9 [hp_X]  in 10 mL
staphylococcus epidermidis immunoserum rabbit (UNII: 8409DJA34Y) (staphylococcus epidermidis immunoserum rabbit - UNII:8409DJA34Y) staphylococcus epidermidis immunoserum rabbit9 [hp_X]  in 10 mL
staphylococcus aureus immunoserum rabbit (UNII: Q1G8TGQ05J) (staphylococcus aureus immunoserum rabbit - UNII:Q1G8TGQ05J) staphylococcus aureus immunoserum rabbit9 [hp_X]  in 10 mL
streptococcus pneumoniae immunoserum rabbit (UNII: IWJ46H2H5C) (streptococcus pneumoniae immunoserum rabbit - UNII:IWJ46H2H5C) streptococcus pneumoniae immunoserum rabbit9 [hp_X]  in 10 mL
mycobacterium bovis immunoserum rabbit (UNII: NNW4543CRP) (mycobacterium bovis immunoserum rabbit - UNII:NNW4543CRP) mycobacterium bovis immunoserum rabbit9 [hp_X]  in 10 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-2808-11 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC04/07/1999
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 10/2010
Document Id: bb2c59f0-e661-46e7-a137-09cee6b48b50
Set id: 68835302-9345-413f-b843-88ec4541e9aa
Version: 1
Effective Time: 20101008
 
Sanum Kehlbeck GmbH & Co. KG