Indications
For temporary relief of external anal itching and irritation.
Pleo Pef
FDA Label NDC 60681-2504
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 60681-2504). 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, warning, tamper evident, active ingredients, inactive ingredients, principal display panel - 30 g ointment carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage
Apply thinly on the affected area 1–3 times daily.
Warning
If symptoms persist more than a few days, contact a licensed practitioner. As with any other drugs, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.
Tamper Evident
Do not use this product if metal seal under the tube cap is missing or broken.
Active Ingredients
1 g ointment contains; 0.1 g Candida parapsilosis 3X.
Inactive Ingredients
lactic acid, lanolin alcohol, glycerylmonostearate, propylene glycol, polyglyceryl-3, cocoate magnesium sulfate, water.
Principal Display Panel - 30 G Ointment Carton
Pleo® Pef
OINTMENT 3X
for topical
use only
Homeopathic
Antipruritic /
External Analgesic
Medicine
The original
SANUM™
brand remedies
Indications: For
temporary relief of
external anal itching
and irritation.
ORIGINAL ENDERLEIN
1.05 oz (30g)
Principal Display Panel (30 g Ointment Carton)
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