KELAN- silicon dioxide, arnica montana root, graphite, hypericum perforatum, ledum palustre twig, magnesium fluoride, magnesium sulfate heptahydrate, and ruta graveolens flowering top ointment

KELAN by

Drug Labeling and Warnings

KELAN by is a Homeopathic medication manufactured, distributed, or labeled by PEKANA Naturheilmittel GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug facts

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

Uses1

Helps reduce scars caused by cuts, scrapes or burns

1 Application 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 indicated.

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.

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.

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

PEKANA®

KELAN™
Homeopathic Ointment

Helps reduce scars caused by
> cuts > scrapes > burns

1.2 OZ
35 g

INGREDIENTS AND APPEARANCE

KELAN 
silicon dioxide, arnica montana root, graphite, hypericum perforatum, ledum palustre twig, magnesium fluoride, magnesium sulfate heptahydrate, and ruta graveolens flowering top ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59469-066
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4)	Silicon Dioxide	6 [hp_X]  in 35 g
Arnica montana Root (UNII: MUE8Y11327) (Arnica montana Root - UNII:MUE8Y11327)	Arnica montana Root	12 [hp_X]  in 35 g
Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O)	Graphite	6 [hp_X]  in 35 g
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB)	Hypericum Perforatum	6 [hp_X]  in 35 g
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P)	RHODODENDRON TOMENTOSUM LEAFY TWIG	12 [hp_X]  in 35 g
Magnesium fluoride (UNII: 5N014C7IWU) (Magnesium fluoride - UNII:5N014C7IWU)	Magnesium fluoride	12 [hp_X]  in 35 g
Magnesium sulfate heptahydrate (UNII: SK47B8698T) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium sulfate heptahydrate	12 [hp_X]  in 35 g
Ruta graveolens Flowering Top (UNII: N94C2U587S) (Ruta graveolens Flowering Top - UNII:N94C2U587S)	Ruta graveolens Flowering Top	12 [hp_X]  in 35 g

Inactive Ingredients
Ingredient Name	Strength
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetyl Alcohol (UNII: 936JST6JCN)
Spermaceti (UNII: P86KHA8V3K)
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59469-066-35	1 in 1 BOX	04/12/2008
1		35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59469-066-30	1 in 1 BOX	04/12/2008
2		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		04/12/2008

Labeler - PEKANA Naturheilmittel GmbH (320344542)

Establishment
Name	Address	ID/FEI	Business Operations
PEKANA Naturheilmittel GmbH		320344542	MANUFACTURE(59469-066)