Pleo Poly D: Homeopathic Product Information

PLEO POLY D- 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.

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

for minor external skin infections.

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: 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 D DROPS 9X (applied topically)

Homeopathic Medicine
Indications: for minor focal external skin infections.
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: antigens 9X of Streptococcus lacticus, -pyogenes, -haemolyticus, –
viridans; Staphylococcus albus, -pharyngis, -aureus; Diplococcus lanceolatus; Mycobacterium
tuberculosis typus bovinusRev. 05/2010

Principal Display Panel- 10 mL Bottle Label
(click image for full-size original)
PLEO POLY D 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:60681-2802
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lactococcus lactis immunoserum rabbit (lactococcus lactis immunoserum rabbit) lactococcus lactis immunoserum rabbit 9 [hp_X] in 10 mL
streptococcus pyogenes immunoserum rabbit (streptococcus pyogenes immunoserum rabbit) streptococcus pyogenes immunoserum rabbit 9 [hp_X] in 10 mL
streptococcus viridans group immunoserum rabbit (streptococcus viridans group immunoserum rabbit) streptococcus viridans group immunoserum rabbit 9 [hp_X] in 10 mL
staphylococcus epidermidis immunoserum rabbit (staphylococcus epidermidis immunoserum rabbit) staphylococcus epidermidis immunoserum rabbit 9 [hp_X] in 10 mL
staphylococcus aureus immunoserum rabbit (staphylococcus aureus immunoserum rabbit) staphylococcus aureus immunoserum rabbit 9 [hp_X] in 10 mL
streptococcus pneumoniae immunoserum rabbit (streptococcus pneumoniae immunoserum rabbit) streptococcus pneumoniae immunoserum rabbit 9 [hp_X] in 10 mL
mycobacterium bovis immunoserum rabbit (mycobacterium bovis immunoserum rabbit) mycobacterium bovis immunoserum rabbit 9 [hp_X] in 10 mL
Inactive Ingredients
Ingredient Name Strength
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60681-2802-1 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (60681-2802-1)
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)

Revised: 10/2010 Sanum Kehlbeck GmbH & Co. KG

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