Indications
For temporary relief of external anal itching and irritation.
Pleo Pef
FDA Label NDC 60681-2501
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 Pef (NDC 60681-2501). 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, ingredients, tamper evident, dosage, warning, principal display panel - 10 ml label, principal display panel - 10 ml box, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 Label)
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)
Principal Display Panel (10 mL Box)
* Please review the disclaimer below.
