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
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-2808-1 - Packager: Sanum Kehlbeck GmbH & Co. KG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated October 8, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
- Indications
- DOSAGE
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WARNING
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.
- INGREDIENTS
- Tamper Evident
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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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
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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/ dropsProduct 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)