Pleo Ut
FDA Label NDC 60681-5305

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 60681-5305). 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 otc - purpose, indications, directions for use, dosage, inactive ingredient, warning, otc - keep out of reach of children, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

Oral Homeopathic Medicine

10 doses, each 1 mL
(.03 fl oz)

Indications

For temporary pain relief of swollen lymph glands.

Directions For Use

Snap off top portion of sipping container. Insert glass sipping straw.

Dosage

1-2 x weekly 1 sip

Inactive Ingredient

1 mL contains Bacillus subtilis 4X, 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.

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.

Tamper Evident

Do not use this product if the glass vial is broken.

Other

Made in Germany

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

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

Rev. 12/2009

Principal Display Panel - 1 Ml Vial Carton

5305-1

Pleo® Ut
PORTABLE SIPS 4X

Oral Homeopathic Medicine

The original
SANUM®
brand remedies

INDICATIONS: For temporary pain relief
of swollen lymph glands.

DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.

DOSAGE: 1-2 x weekly 1 sip

INGREDIENTS: 1 mL contains Bacillus
subtilis 4X, in a base of purified saline
solution.

Tamper Evident: Do not use this product
if the glass vial is broken.

convenient, disposable
single dose containers

10 doses, each 1 mL
(.03 fl oz)

Rev. 12/2009

800IN4XSE10US912

Principal Display Panel (1 mL Vial Carton)

Principal Display Panel (1 mL Vial Carton)

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