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Drug facts
Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg
Distributed by:
BioResource Inc.
Cotati, CA 94931
Made in Germany
Kelan Ointment
FDA Label NDC 59469-066
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pekana Naturheilmittel Gmbh for the product Kelan (NDC 59469-066). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, directions, other information, tamper evident, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
| Active ingredients | |
|---|---|
| Selected ingredients prepared by spagyric processes. | |
| Acidum silicicum (Silicea) | 6X |
| Arnica montana | 12X |
| Graphites | 6X |
| Hypericum perforatum | 6X |
| Ledum palustre | 12X |
| Magnesium fluoratum | 12X |
| Magnesium sulfuricum | 12X |
| Ruta graveolens | 12X |
Otc - Purpose
Helps reduce scars caused by cuts, scrapes or burns
Warnings
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
Keep out of the reach of children.
Directions
Unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into the affected area.
Other Information
Protect from light and heat.
Tamper Evident
Do not use this product if tamper evident strip is broken or removed from base of cap.
Inactive Ingredients
Purified water, cetylstearyl alcohol, synthetic cetaceum, triglycerides.
Principal Display Panel - 35 G Tube Box
PEKANA®
KELAN™
Homeopathic Ointment
Helps reduce scars caused by
> cuts > scrapes > burns
1.2 OZ
35 g
Principal Display Panel (35 g Tube Box)
* Please review the disclaimer below.
