PLEO CAL- giant puffball solution/ drops

Pleo Cal by

Drug Labeling and Warnings

Pleo Cal 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

Indications

To reduce bleeding from cuts and scrapes.

INGREDIENTS

10 mL Calvatia gigantea 3X in a base of purified water, ethanol (70%).

Tamper Evident

Use this product only if tamper evident strip has not been broken or removed from base of cap.

DOSAGE

5–10 drops, 1–3 times 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. 6/98

PRINCIPAL DISPLAY PANEL - 10 mL Label

Pleo™ Cal DROPS 3X

Homeopathic Medicine

Indications: To reduce bleeding from cuts and scrapes.

0.34 fl oz (10 mL)

DOSAGE: 5–10 drops, 1–3 times 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 Calvatia gigantea
3X in a base of purified water, ethanol (70%).
Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 10 mL Box

Pleo™ Cal
DROPS 3X

Homeopathic
Medicine

Indications: To
reduce bleeding
from cuts and
scrapes.

0.34 fl oz
(10 mL)

INGREDIENTS AND APPEARANCE

PLEO CAL 
giant puffball solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-0111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GIANT PUFFBALL (UNII: I6839Y031A) (GIANT PUFFBALL - UNII:I6839Y031A)	GIANT PUFFBALL	3 [hp_X]  in 10 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: 60681-0111-1	1 in 1 CARTON
1		10 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)