Indications
For temporary relief of yeast infections.
Pleo Ex
FDA Label NDC 60681-1005
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 60681-1005). 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, directions for use, dosage, ingredients, warning, tamper evident, principal display panel - 1 ml carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Directions For Use
Snap off top portion of sipping container. Insert glass sipping straw.
Dosage
1 SIP, twice weekly.
Ingredients
1 mL contains Candida albicans 5X, Candida parapsilosis 5X, Penicillium roquefortii 5X in a base of purified saline solution.
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.
Tamper Evident
Do not use this product if the glass vial is broken or if imprinted security strip on carton is torn.
Principal Display Panel - 1 Ml Carton
1005-1
Pleo™ Ex
PORTABLE SIPS 5X
Oral Homeopathic Medicine
INDICATIONS: For temporary relief of
yeast infections.
DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.
DOSAGE: 1 SIP, twice weekly.
INGREDIENTS: 1 mL contains Candida
albicans 5X, Candida parapsilosis 5X,
Penicillium roquefortii 5X in a base of pu-
rified saline solution.
ORIGINAL ENDERLEIN
convenient, disposable
single dose containers
10 doses, each 1 mL
(.03 fl oz)
Rev. 10/2002
Principal Display Panel (1 mL Carton)
* Please review the disclaimer below.
