Pleo Poly E: Homeopathic Product Information

PLEO POLY E- treponema pallidum 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

to reduce minor inflammation.

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 Treponema pallidum.

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 E DROPS 9X (applied topically)

Homeopathic Medicine
Indications: to reduce minor inflammation.
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 Treponema pallidum. Rev. 05/2010

PRINCIPAL DISPLAY PANEL -- 10 mL Bottle Label
(click image for full-size original)
PLEO POLY E treponema pallidum immunoserum rabbit solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-2804
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
treponema pallidum immunoserum rabbit (treponema pallidum immunoserum rabbit) treponema pallidum immunoserum rabbit 9 [hp_X] in 10 mL
Inactive Ingredients
Ingredient Name Strength
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60681-2804-1 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 (60681-2804-1)
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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