Indications
for minor focal oral infections.
Pleo Poly Dx
FDA Label NDC 60681-2803
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanum Kehlbeck Gmbh & Co. Kg for the product Pleo Poly Dx (NDC 60681-2803). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications, dosage, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - when using, ingredients, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Principal Display Panel (10 mL Bottle Label)
* Please review the disclaimer below.
