Pleo Ut
FDA Label NDC 60681-5301

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 Ut (NDC 60681-5301). 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 dosage, warning, otc - keep out of reach of children, storage and handling, ingredients, tamper evident, other, principal display panel - 5 ml bottle carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Dosage

1–3 times weekly 2–5 drops 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.

Otc - Keep Out Of Reach Of Children

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.

Storage And Handling

Protect from light and heat.

Ingredients

5 mL Bacillus subtilis 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.

Other

Manufactured by:
SANUM-Kehlbeck
GmbH & Co. KG,
Hoya, Germany

Distributed by:
SANUM USA Corp.,
1465 Slater Road,
Ferndale, WA 98248

Principal Display Panel - 5 Ml Bottle Carton

Pleo® Ut

DROPS 6X
Homeopathic
Analgesic
Medicine

The original
SANUM®
brand remedies

Indications: For
temporary pain
relief of swollen
lymph glands.

0.17 fl oz
(5 mL)

Principal Display Panel (5 mL Bottle Carton)

Principal Display Panel (5 mL Bottle Carton)

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