FDA.reportPublic FDA data

KELAN

Manufacturer
PEKANA Naturheilmittel GmbH
Effective date
2022-12-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:19:04

Label at a glance#

ProductKELAN
Active ingredientSilicon Dioxide, Arnica montana Root, Graphite, HYPERICUM PERFORATUM WHOLE, RHODODENDRON TOMENTOSUM LEAFY TWIG, Magnesium fluoride, Magnesium sulfate heptahydrate, Ruta graveolens Flowering Top
Label structure9 sections

Indications and uses

Helps reduce scars caused by cuts, scrapes or burns

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
Selected ingredients prepared by spagyric processes.
Acidum silicicum (Silicea)6X
Arnica montana12X
Graphites6X
Hypericum perforatum6X
Ledum palustre12X
Magnesium fluoratum12X
Magnesium sulfuricum12X
Ruta graveolens12X

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

Helps reduce scars caused by cuts, scrapes or burns

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, synthetic cetaceum, triglycerides.

SPL UNCLASSIFIED SECTION

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

Distributed by:
BioResource Inc.
Cotati, CA 94931
Made in Germany

PRINCIPAL DISPLAY PANEL - 35 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEKANA®

KELAN™
Homeopathic Ointment

Helps reduce scars caused by
> cuts > scrapes > burns

1.2 OZ
35 g

PRINCIPAL DISPLAY PANEL - 35 g Tube Box
PRINCIPAL DISPLAY PANEL - 35 g Tube Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-066-30KELAN1 in 1 BOXOINTMENT16
59469-066-30KELAN30 g in 1 TUBEOINTMENT306
59469-066-35KELAN1 in 1 BOXOINTMENT16
59469-066-35KELAN35 g in 1 TUBEOINTMENT356

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-066KELAN (SILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOP) OINTMENT [PEKANA NATURHEILMITTEL GMBH]6Current NDC, Legacy NDC, 4 package rows20221223_55786d99-ee1f-490f-9023-3e6c39da86b0.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
59469-06659469-066-35, 59469-066-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Silicon DioxideETJ7Z6XBU4ACTIB
Arnica montana RootMUE8Y11327ACTIB
Graphite4QQN74LH4OACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
Magnesium fluoride5N014C7IWUACTIB
Magnesium sulfate heptahydrateSK47B8698TACTIB
Ruta graveolens Flowering TopN94C2U587SACTIB
Medium-Chain TriglyceridesC9H2L21V7UIACT
Cetostearyl Alcohol2DMT128M1SIACT
Cetyl Alcohol936JST6JCNIACT
SpermacetiP86KHA8V3KIACT
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
KELANSILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOPPEKANA Naturheilmittel GmbH55786d99-ee1f-490f-9023-3e6c39da86b02022-12-22WarningsExact identifier
ndc (package): 59469-066-30
ndc (package): 59469-066-35
ndc (product): 59469-066
ndc11 (package): 59469006630
ndc11 (package): 59469006635
spl id: 63d764d3-3f6c-4445-ac66-40ef9869b161
spl set id: 55786d99-ee1f-490f-9023-3e6c39da86b0

Reported adverse events (FAERS/openFDA)#

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