FDA Label for Pleo Poly R
View Indications, Usage & Precautions
Pleo Poly R 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
pain associated with rheumatism, gout and arthritis.
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: antitoxins and antigens 9X of Mycobacterium tuberculosis typus bovinus and brevis, Streptococcus pyogenes.
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 R DROPS 9X (applied topically)
Homeopathic Medicine
Indications: pain associated with rheumatism, gout and arthritis.
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 Mycobacterium tuberculosis typus
bovinus and brevis, Streptococcus pyogenes.
Rev. 05/2010
* Please review the disclaimer below.