PLEO USTI- ustilago maydis solution/ drops

Pleo Usti by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

For temporary relief of menopausal symptoms.

INGREDIENTS

10 mL Ustilago zeae e sporibus rec. 5X 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

5–10 drops, once daily, 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.

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.

SPL UNCLASSIFIED SECTION

Made in Germany

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

Manufactured By:
Sanum-Kehlbeck,
GmbH & Co. KG

Rev. 08/2005

PRINCIPAL DISPLAY PANEL - 10 mL Label

Pleo™ Usti DROPS 5X

Homeopathic Medicine

Indications: For temporary relief of menopausal symptoms.

0.34 fl oz (10 mL)

DOSAGE:5–10 drops, once daily, 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.
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 tamper-evident
seal on base of bottle cap is missing or broken. INGREDIENTS: 10 mL Ustilago zeae e
sporibus rec. 5X in a base of purified water.
Rev. 06/2009

INGREDIENTS AND APPEARANCE

PLEO USTI 
ustilago maydis solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-5601
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ustilago maydis (UNII: 4K7Z7K7SWG) (ustilago maydis - UNII:4K7Z7K7SWG)	ustilago maydis	5 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-5601-1	1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		08/19/1998

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