Indications
For temporary relief of earache.
Pleo San Prot
FDA Label NDC 60681-1245
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 San Prot (NDC 60681-1245). 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, every 1–3 days.
Ingredients
1 mL contains Proteus vulgaris 7X, 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
1245-2
Pleo™ San PROT
PORTABLE SIPS 7X
Oral Homeopathic Medicine
INDICATIONS: For temporary relief of
earache.
DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.
DOSAGE: 1 SIP, every 1–3 days.
INGREDIENTS: 1 mL contains Proteus
vulgaris 7X, in a base of purified saline
solution.
convenient, disposable
single dose containers
50 doses, each 1 mL
(.03 fl oz)
Rev. 11/97
Principal Display Panel (1 mL Carton)
* Please review the disclaimer below.
