Indications
For temporary relief of yeast infections.
Pleo Ex
FDA Label NDC 60681-1001
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 Ex (NDC 60681-1001). 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, active ingredients per dose, inactive ingredients, dosage, warning, tamper evident, principal display panel - 10 suppositories carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients Per Dose
0.067 g Candida albicans 3X, 0.067 g Candida parapsilosis 3X, 0.067 g Penicillium roquefortii 3X.
Inactive Ingredients
hydrogenated palm kernel glycerides, lactose.
Dosage
Once daily, insert one suppository rectally at bedtime.
Warning
If symptoms persist more than a few days, contact a licensed practitioner. As with 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 imprinted inner plastic shell is broken or if imprinted security strip on carton package is torn.
Principal Display Panel - 10 Suppositories Carton
Pleo™ Ex
SUPPOSITORIES 3X
Homeopathic Antifungal Medicine
Indications: For temporary
relief of yeast infections.
ORIGINAL ENDERLEIN
10 SUPPOSITORIES
Principal Display Panel (10 Suppositories Carton)
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