FDA Label for Pleo Poly Dx

View Indications, Usage & Precautions

Pleo Poly Dx Product Label

The following document was submitted to the FDA by the labeler of this product Sanum Kehlbeck Gmbh & Co. Kg. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Indications



for minor focal oral infections.


Dosage



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


Otc - Ask Doctor



If symptoms persist more than a few days, contact a licensed practitioner.


Otc - Pregnancy Or Breast Feeding



As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.


Otc - Keep Out Of Reach Of Children



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.


Otc - When Using



Protect from light and heat.


Ingredients



10 mL aqueous dilution contains: antigens 9X of Streptococcus lanceolatus, Staphylococcus aureus, Diplococcus pneumoniae..


Inactive Ingredient



Inactive Ingredient water


Tamper Evident



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


Other



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 Dx DROPS 9X (applied topically)

Homeopathic Medicine
Indications: for minor focal oral 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 lanceolatus, Staphylococcus aureus,
Diplococcus pneumoniae.
Rev. 05/2010


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