PLEO PEF- candida parapsilosis ointment

Pleo Pef by

Drug Labeling and Warnings

Pleo Pef 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

for topical use only
Homeopathic Antipruritic / External Analgesic Medicine

1.05 oz (30g)

Indications

For temporary relief of external anal itching and irritation.

DOSAGE

Apply thinly on the affected area 1–3 times daily.

WARNING

If symptoms persist more than a few days, contact a licensed practitioner. As with any other drugs, 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 ingestion, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING

Protect from light and heat.

Tamper Evident

Do not use this product if metal seal under the tube cap is missing or broken.

INGREDIENTS

Active Ingredients

1 g ointment contains; 0.1 g Candida parapsilosis 3X.

Inactive Ingredients

lactic acid, lanolin alcohol, glycerylmonostearate, propylene glycol, polyglyceryl-3, cocoate magnesium sulfate, water.

SPL UNCLASSIFIED SECTION

Made in Germany

Manufactured by:
SANUM-Kehlbeck
GmbH & Co. KG,
Hoya, Germany

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

Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 30 g Ointment Carton

Pleo® Pef
OINTMENT 3X

for topical
use only
Homeopathic
Antipruritic /
External Analgesic
Medicine

The original
SANUM™
brand remedies

Indications: For
temporary relief of
external anal itching
and irritation.

ORIGINAL ENDERLEIN

1.05 oz (30g)

INGREDIENTS AND APPEARANCE

PLEO PEF 
candida parapsilosis ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
candida parapsilosis (UNII: 0KZ676D44N) (candida parapsilosis - UNII:0KZ676D44N)	candida parapsilosis	3 [HP_X]  in 30 g

Inactive Ingredients
Ingredient Name	Strength
glyceryl monostearate (UNII: 230OU9XXE4)
lactic acid (UNII: 33X04XA5AT)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-2504-1	1 in 1 CARTON
1		30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		03/19/1996

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