Pleo™ Cal DROPS 3X

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2009-09-28
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:48

Label at a glance#

ProductPleo Cal

Active ingredientGIANT PUFFBALL

Label structure10 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Medicine

Indications

INDICATIONS & USAGE SECTION

To reduce bleeding from cuts and scrapes.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

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

Tamper Evident

OTC - DO NOT USE SECTION

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

DOSAGE

DOSAGE & ADMINISTRATION SECTION

5–10 drops, 1–3 times daily, before mealtime.

WARNING

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Cal
DROPS 3X

Homeopathic
Medicine

Indications: To
reduce bleeding
from cuts and
scrapes.

0.34 fl oz
(10 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-0111-1	2019-10-21	C162847	48780-1	956f9ecf-d9ce-621f-e053-dbdaa90a74ad	Pleo™ Cal DROPS 3X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-0111-1	Pleo Cal	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		1
60681-0111-1	Pleo Cal	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-0111	PLEO CAL (GIANT PUFFBALL) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 2 package rows	20110113_256aad08-3455-4e12-bccb-672ef0e08330.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GIANT PUFFBALL	ACTIVE INGREDIENT	I6839Y031A	1
GIANT PUFFBALL	ACTIVE MOIETY	I6839Y031A	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Pleo Cal
GIANT PUFFBALL
water
alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-0111	60681-0111-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GIANT PUFFBALL	I6839Y031A	ACTIB
water	059QF0KO0R	IACT
alcohol	3K9958V90M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6d9dea98-74a3-4cd0-9b21-7965d526ea31			256aad08-3455-4e12-bccb-672ef0e08330	2009-09-28	Warnings	Exact identifier spl id: 6d9dea98-74a3-4cd0-9b21-7965d526ea31 spl set id: 256aad08-3455-4e12-bccb-672ef0e08330

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.