Pleo San Prot
FDA Label NDC 60681-1244

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 60681-1244). 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, inactive ingredient, tamper evident, dosage, warning, principal display panel - 10 ml bottle carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications

For temporary relief of otitis and chronic indigestion.

Inactive Ingredient

10 mL Proteus vulgaris 6X 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

1-2 × daily 5-10 drops.

Warning

If symptoms persist more than a few days, contact a licensed practitioner. As with any other drugs, 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 Carton

Pleo® San

PROT
DROPS 6X

Homeopathic
Medicine

The original
SANUM®
brand remedies

Indications:
For temporary
relief of otitis
and chronic
indigestion.

0.34 fl oz
(10 mL)

Principal Display Panel (10 mL Bottle Carton)

Principal Display Panel (10 mL Bottle Carton)

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