Indications
For temporary relief of yeast infections.
Pleo Ex
FDA Label NDC 60681-1003
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 60681-1003). 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 bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ingredients
10 mL contain 3.33mL Candida albicans 5X, 3.33mL Candida parapsilosis 5X and 3.33mL Penicillium roquefortii 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.
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 Bottle Label
Pleo® Ex DROPS 5X
Homeopathic Antifungal Medicine
Indications: For temporary relief of yeast infections
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 contain 3.33mL Candida albicans 5X, 3.33mL Candida parapsilosis 5X, 3.33mL
Penicillium roquefortii 5X in a base of purified water.
Rev. 04/2010
Principal Display Panel (10 mL Bottle Label)
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