Label: ZELLULISAN- horse chestnut, arnica montana, betula pendula leaf, hedera helix flowering twig, ledum palustre twig, melilotus officinalis top, toxicodendron pubescens leaf, and sulfur ointment

  • NDC Code(s): 59469-038-35
  • 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 21, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug facts

  • ACTIVE INGREDIENT

    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.

  • Uses1

    For relief of minor tendinitis and inflammation

    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, glycerol, synthetic cetaceum, triglycerides.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    PEKANA® GmbH
    D-88353 Kisslegg

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

  • PRINCIPAL DISPLAY PANEL - 35 g Tube Carton

    PEKANA®

    ZELLULISAN™
    Homeopathic Ointment

    For relief of minor tendinitis and inflammation

    1.2 OZ
    35 g

    PRINCIPAL DISPLAY PANEL - 35 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ZELLULISAN 
    horse chestnut, arnica montana, betula pendula leaf, hedera helix flowering twig, ledum palustre twig, melilotus officinalis top, toxicodendron pubescens leaf, and sulfur ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    horse chestnut (UNII: 3C18L6RJAZ) (horse chestnut - UNII:3C18L6RJAZ) horse chestnut4 [hp_X]  in 35 g
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE8 [hp_X]  in 35 g
    betula pendula leaf (UNII: 5HW39H9KDH) (betula pendula leaf - UNII:5HW39H9KDH) betula pendula leaf8 [hp_X]  in 35 g
    hedera helix flowering twig (UNII: 3D10KUA6BM) (hedera helix flowering twig - UNII:3D10KUA6BM) hedera helix flowering twig6 [hp_X]  in 35 g
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG3 [hp_X]  in 35 g
    melilotus officinalis top (UNII: GM6P02J2DX) (melilotus officinalis top - UNII:GM6P02J2DX) melilotus officinalis top4 [hp_X]  in 35 g
    toxicodendron pubescens leaf (UNII: 6IO182RP7A) (toxicodendron pubescens leaf - UNII:6IO182RP7A) toxicodendron pubescens leaf8 [hp_X]  in 35 g
    sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70) sulfur15 [hp_X]  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    glycerin (UNII: PDC6A3C0OX)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    cetyl esters wax (UNII: D072FFP9GU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-038-351 in 1 CARTON02/20/2011
    135 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/20/2011
    Labeler - Pekana-Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pekana-Naturheilmittel GmbH320344542Manufacture(59469-038)
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