PLEO UT- bacillus subtilis liquid

Pleo Ut by

Drug Labeling and Warnings

Pleo Ut by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS

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.

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 the glass vial is broken.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PLEO UT 
bacillus subtilis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-5305
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacillus subtilis (UNII: 8CF93KW41W) (bacillus subtilis - UNII:8CF93KW41W)	bacillus subtilis	4 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium chloride (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-5305-1	10 in 1 CARTON
1		1 mL in 1 VIAL, GLASS
2	NDC: 60681-5305-2	50 in 1 CARTON
2		1 mL in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		03/19/1997

Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)