Indications
For temporary relief of external itching and soreness in the urogenital region.
Pleo Nig
FDA Label NDC 60681-2104
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 Nig (NDC 60681-2104). 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 ingredient 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 Ingredient Per Dose
0.2 g Aspergillus niger 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 any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before taking this product.
Tamper Evident
Do not use this product if imprinted inner plastic shell is broken or if imprinted security strip on carton is torn.
Principal Display Panel - 10 Suppositories Carton
Pleo™ Nig
SUPPOSITORIES 3X
Homeopathic Antipruritic Medicine
Indications: For temporary
relief of external itching and soreness
in the urogenital region.
ORIGINAL ENDERLEIN
10 SUPPOSITORIES
Principal Display Panel (10 Suppositories Carton)
* Please review the disclaimer below.
