PLEO ZINC- zinc gluconate solution/ drops

Pleo Zinc by

Drug Labeling and Warnings

Pleo Zinc by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG, 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 temporary relief of symptoms of acne and eczema.

INACTIVE INGREDIENT

INGREDIENTS

2.4 mL Zincum gluconicum 3X in a base of purified water and alcohol 20% by volume.

Tamper Evident

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

DOSAGE

In case of acute conditions every half to one hour, not more than 6 × daily each 5 drops.

In case of chronic forms 1-3 × daily 5 drops.

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 other 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 fom 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
Hoya, Germany

Rev. 03/2010

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Pleo® Zinc
DROPS 3X

Homeopathic
Medicine

The original
SANUM®
brand remedies

Indications:
For temporary relief of
symptoms of acne and
eczema.

1 fl oz
(30 mL)

INGREDIENTS AND APPEARANCE

PLEO ZINC 
zinc gluconate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-5502
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
zinc gluconate (UNII: U6WSN5SQ1Z) (zinc cation - UNII:13S1S8SF37)	zinc gluconate	3 [hp_X]  in 30 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-5502-1	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		06/15/2010

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

Establishment
Name	Address	ID/FEI	Business Operations
SANUM KEHLBECK GmbH & Co. KG		318386133	MANUFACTURE(60681-5502)