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

  • NDC Code(s): 59469-066-30, 59469-066-35
  • Packager: PEKANA Naturheilmittel GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 6, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug facts

  • ACTIVE INGREDIENT

    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
  • 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

    PRINCIPAL DISPLAY PANEL - 35 g Tube Box
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-066
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide6 [hp_X]  in 35 g
    Arnica montana Root (UNII: MUE8Y11327) (Arnica montana Root - UNII:MUE8Y11327) Arnica montana Root12 [hp_X]  in 35 g
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite6 [hp_X]  in 35 g
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum6 [hp_X]  in 35 g
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG12 [hp_X]  in 35 g
    Magnesium fluoride (UNII: 5N014C7IWU) (Magnesium fluoride - UNII:5N014C7IWU) Magnesium fluoride12 [hp_X]  in 35 g
    Magnesium sulfate heptahydrate (UNII: SK47B8698T) (Magnesium Cation - UNII:T6V3LHY838) Magnesium sulfate heptahydrate12 [hp_X]  in 35 g
    Ruta graveolens Flowering Top (UNII: N94C2U587S) (Ruta graveolens Flowering Top - UNII:N94C2U587S) Ruta graveolens Flowering Top12 [hp_X]  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Spermaceti (UNII: P86KHA8V3K)  
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-066-351 in 1 BOX04/12/2008
    135 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:59469-066-301 in 1 BOX04/12/2008
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/12/2008
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-066)