FDA.reportPublic FDA data

ZELLULISAN

Manufacturer
PEKANA Naturheilmittel GmbH
Effective date
2022-12-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:19:03

Label at a glance#

ProductZELLULISAN
Active ingredientARNICA MONTANA ROOT, RHODODENDRON TOMENTOSUM LEAFY TWIG, TOXICODENDRON PUBESCENS SHOOT, SULFUR, HORSE CHESTNUT, BETULA PENDULA LEAF, HEDERA HELIX FLOWERING TWIG, MELILOTUS OFFICINALIS TOP
Label structure9 sections

Indications and uses

For relief of minor tendinitis and inflammation

Dosage and administration

Unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into the affected area.

Storage and handling

Protect from light and heat. Do not use this product if tamper evident strip is broken or removed from base of cap.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Aesculus hippocastanum4X
Arnica montana8X
Betula pendula e foliis (Betula folium)8X
Hedera helix6X
Ledum palustre3X
Melilotus officinalis4X
Toxicodendron quercifolium (Rhus toxicodendron)8X
Sulfur15X

Selected ingredients prepared by spagyric processes.

UsesApplication of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. These "Uses" have not been evaluated by the Food and Drug Administration. With severe forms of this disease, a clinically proven therapy is i...

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For relief of minor tendinitis and inflammation

Warnings

WARNINGS SECTION

For external use only. Do not use on open wounds! If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into the affected area.

Other information

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

SPL UNCLASSIFIED SECTION

Do not use this product if tamper evident strip is broken or removed from base of cap.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, cetylstearyl alcohol, glycerol, synthetic cetaceum, triglycerides.

SPL UNCLASSIFIED SECTION

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

Distributed by:
BioResource Inc.
Cotati, CA 94931

PRINCIPAL DISPLAY PANEL - 100 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEKANA®

ZELLULISAN™

Homeopathic Ointment

For relief of minor tendinitis and inflammation

3.5 OZ
100 g

Principal Display Panel - 100 g Tube Box
Principal Display Panel - 100 g Tube Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-138-30ZELLULISAN1 in 1 BOXOINTMENT16
59469-138-30ZELLULISAN30 g in 1 TUBEOINTMENT306
59469-138-40ZELLULISAN100 g in 1 TUBEOINTMENT1006
59469-138-40ZELLULISAN1 in 1 BOXOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-138ZELLULISAN (ARNICA MONTANA ROOT, LEDUM PALUSTRE TWIG, TOXICODENDRON PUBESCENS SHOOT, SULFUR, HORSE CHESTNUT, BETULA PENDULA LEAF, HEDERA HELIX FLOWERING TWIG, AND MELILOTUS OFFICINALIS TOP) OINTMENT [PEKANA NATURHEILMITTEL GMBH]6Current NDC, Legacy NDC, 4 package rows20221223_2fe46c61-93d0-45b0-b9bd-356cd7347eb7.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59469-13859469-138-40, 59469-138-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA ROOTMUE8Y11327ACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
TOXICODENDRON PUBESCENS SHOOT46PYZ1F82MACTIB
SULFUR70FD1KFU70ACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
BETULA PENDULA LEAF5HW39H9KDHACTIB
HEDERA HELIX FLOWERING TWIG3D10KUA6BMACTIB
MELILOTUS OFFICINALIS TOPGM6P02J2DXACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
SPERMACETIP86KHA8V3KIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZELLULISANARNICA MONTANA ROOT, LEDUM PALUSTRE TWIG, TOXICODENDRON PUBESCENS SHOOT, SULFUR, HORSE CHESTNUT, BETULA PENDULA LEAF, HEDERA HELIX FLOWERING TWIG, AND MELILOTUS OFFICINALIS TOPPEKANA Naturheilmittel GmbH2fe46c61-93d0-45b0-b9bd-356cd7347eb72022-12-20WarningsExact identifier
ndc (package): 59469-138-30
ndc (package): 59469-138-40
ndc (product): 59469-138
ndc11 (package): 59469013830
ndc11 (package): 59469013840
spl id: d5fc8058-6238-444a-a718-1eedb4b81b91
spl set id: 2fe46c61-93d0-45b0-b9bd-356cd7347eb7

Reported adverse events (FAERS/openFDA)#

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