FDA Label for Pleo Pef

View Indications, Usage & Precautions

Pleo Pef 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 temporary relief of external anal itching and irritation.


Ingredients



Contains 10 mL Candida parapsilosis 5X in a base of purified water.


Tamper Evident



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


Dosage



5–10 drops, once daily, before mealtime.


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.


Principal Display Panel - 10 Ml Label



Pleo™ Pef DROPS 5X

Homeopathic Antifungal Medicine

Indications: For temporary relief of external anal itching and irritation.

0.34 fl oz (10 mL)

DOSAGE: 5–10 drops, once daily, before mealtime. 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 Candida parapsilosis
5X in a base of purified water.
Rev. 06/2009


Principal Display Panel - 10 Ml Box



Pleo™ Pef
DROPS 5X

Homeopathic
Antifungal
Medicine

Indications: For
temporary relief
of external anal
itching and
irritation.

ORIGINAL ENDERLEIN

0.34 fl oz
(10 mL)


* Please review the disclaimer below.