PLEO SPERMUS- manuka oil solution/ drops

Pleo Spermus by

Drug Labeling and Warnings

Pleo Spermus 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

1 fl oz
(30 mL)

Indications

For relief of diarrhea and stomach upset.

INGREDIENTS

30 mL contains: Leptospermum scoparium 1X in a base of purified water, ethanol (70%).

Tamper Evident

Use this product only if tamper-evident strip on base of bottle cap is intact.

DOSAGE

Take 5 drops, 1–3 times daily, unless otherwise recommended by your health care professional.

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. 08/2000

PRINCIPAL DISPLAY PANEL - 30 mL Label

Pleo™ Spermus DROPS 1X

Homeopathic Medicine

Indications: For relief of diarrhea and stomach upset.

1 fl oz (30 mL)

DOSAGE: Take 5 drops 1-3 times daily; unless otherwise recommended by your health care
professional. WARNING: If symptoms persist, contact a licensed practitioner. If pregnant or
nursing, seek advice of a health care professional before use. 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: 30 mL contains: Leptospermum scoparium 1X in a base of purified water,
ethanol (70 %).
Rev. 06/2009

INGREDIENTS AND APPEARANCE

PLEO SPERMUS 
manuka oil solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-1311
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Manuka Oil (UNII: M6QU9ZUH2X) (Manuka Oil - UNII:M6QU9ZUH2X)	Manuka Oil	1 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
alcohol (UNII: 3K9958V90M)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-1311-3	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		01/01/2006

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