<?xml version="1.0" encoding="UTF-8" standalone="no"?><?xml-stylesheet href="../../stylesheet/spl.xsl" type="text/xsl"?><document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 http://www.accessdata.fda.gov/spl/schema/spl.xsd">
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  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <effectiveTime value="20120228"/>
  <setId root="9cd09f43-5049-4aaf-9cae-a017dcb39cf0"/>
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  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="315635359" root="1.3.6.1.4.1.519.1"/>
        <name>Biologische Heilmittel Heel</name>
        <assignedEntity>
          <assignedOrganization/>
        </assignedEntity>
      </representedOrganization>
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          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="51885-3353" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Zeel<suffix/>
                </name>
                <formCode code="C42966" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OINTMENT"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>SILICON DIOXIDE and COMFREY ROOT and ARNICA MONTANA ROOT and TOXICODENDRON PUBESCENS LEAF and SULFUR and SANGUINARIA CANADENSIS ROOT and SOLANUM DULCAMARA STEM  and COENZYME A and NADIDE and  SODIUM DIETHYL OXALACETATE  and .ALPHA.-LIPOIC ACID and SUS SCROFA CARTILAGE  and SUS SCROFA EMBRYO and SUS SCROFA UMBILICAL CORD and  SUS SCROFA PLACENTA  and </name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="6"/>
                    <denominator unit="g" value="50"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SILICON DIOXIDE</name>
                    <activeMoiety>
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                        <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SILICON DIOXIDE</name>
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                <ingredient classCode="ACTIB">
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                    <numerator unit="[hp_X]" value="8"/>
                    <denominator unit="g" value="50"/>
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                  <ingredientSubstance>
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                    <name>COMFREY ROOT </name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="M9VVZ08EKQ" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>COMFREY ROOT </name>
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                    <numerator unit="[hp_X]" value="2"/>
                    <denominator unit="g" value="50"/>
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                    <code code="MUE8Y11327" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ARNICA MONTANA ROOT</name>
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                      <activeMoiety>
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                        <name>ARNICA MONTANA ROOT</name>
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                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="2"/>
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                  </quantity>
                  <ingredientSubstance>
                    <code code="6IO182RP7A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TOXICODENDRON PUBESCENS LEAF </name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="6IO182RP7A" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>TOXICODENDRON PUBESCENS LEAF </name>
                      </activeMoiety>
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                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="6"/>
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                  <ingredientSubstance>
                    <code code="70FD1KFU70" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SULFUR</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="70FD1KFU70" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SULFUR</name>
                      </activeMoiety>
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                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="2"/>
                    <denominator unit="g" value="50"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="N9288CD508" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SANGUINARIA CANADENSIS ROOT</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="N9288CD508" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SANGUINARIA CANADENSIS ROOT</name>
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                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="2"/>
                    <denominator unit="g" value="50"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="IR986LE7DF" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SOLANUM DULCAMARA STEM </name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="IR986LE7DF" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SOLANUM DULCAMARA STEM </name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="6"/>
                    <denominator unit="g" value="50"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="SAA04E81UX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>COENZYME A </name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="SAA04E81UX" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>COENZYME A </name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="6"/>
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                  </quantity>
                  <ingredientSubstance>
                    <code code="0U46U6E8UK" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>NADIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="0U46U6E8UK" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>NADIDE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="6"/>
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                  </quantity>
                  <ingredientSubstance>
                    <code code="6CA025Y4FG" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM DIETHYL OXALACETATE </name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="9NEZ333N27" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SODIUM</name>
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                    </activeMoiety>
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                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="6"/>
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                  </quantity>
                  <ingredientSubstance>
                    <code code="73Y7P0K73Y" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>.ALPHA.-LIPOIC ACID</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="73Y7P0K73Y" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>.ALPHA.-LIPOIC ACID</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="2"/>
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                  </quantity>
                  <ingredientSubstance>
                    <code code="73ECW5WG2F" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUS SCROFA CARTILAGE </name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="73ECW5WG2F" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SUS SCROFA CARTILAGE </name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="2"/>
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                  </quantity>
                  <ingredientSubstance>
                    <code code="9928MC12VO" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUS SCROFA EMBRYO</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="9928MC12VO" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SUS SCROFA EMBRYO</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
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                  </quantity>
                  <ingredientSubstance>
                    <code code="118OYG6W3H" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUS SCROFA UMBILICAL CORD </name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="118OYG6W3H" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SUS SCROFA UMBILICAL CORD </name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
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                  </quantity>
                  <ingredientSubstance>
                    <code code="C8CV8867O8" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUS SCROFA PLACENTA </name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="C8CV8867O8" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SUS SCROFA PLACENTA </name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="2DMT128M1S" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CETOSTEARYL ALCOHOL</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ALCOHOL </name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="4T6H12BN9U" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PETROLATUM  </name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="I9O0E3H2ZE" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PARAFFIN </name>
                  </ingredientSubstance>
                </ingredient>
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                  <quantity>
                    <numerator unit="g" value="50"/>
                    <denominator value="1"/>
                  </quantity>
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                    <code/>
                    <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
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                      <quantity>
                        <numerator unit="1" value="1">
                          <translation code="C48549" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
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                        <denominator value="1"/>
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                        <code code="51885-3353-1" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
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                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="g" value="50"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
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                      <quantity>
                        <numerator unit="1" value="1">
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                        <denominator value="1"/>
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                      <containerPackagedProduct>
                        <code code="51885-3353-3" codeSystem="2.16.840.1.113883.6.69"/>
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                      </containerPackagedProduct>
                    </asContent>
                  </containerPackagedProduct>
                </asContent>
              </manufacturedProduct>
              <subjectOf>
                <marketingAct>
                  <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                  <statusCode code="active"/>
                  <effectiveTime>
                    <low value="20111020"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <subjectOf>
                <approval>
                  <code code="C73614" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="unapproved homeopathic"/>
                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                      </territory>
                    </territorialAuthority>
                  </author>
                </approval>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38304" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TOPICAL"/>
                </substanceAdministration>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>ACTIVE INGREDIENTS</title>
          <text>
            <paragraph>
              <content styleCode="bold">Active ingredients:</content> Each 50g of ointment contains: Silicea 6X 0.5g; Symphytum officinale 8X
0.375g; Arnica montana, radix 2X 0.15g; Rhus toxicodendron 2X 0.135g;
Sulphur 6X 0.135g; Sanguinaria canadensis 2X 0.113g; Dulcamara 2X
0.038g; Coenzyme A 6X 0.005g; Nadidum 6X 0.005g; Natrum oxalaceticum 6X
0.005g;<content> α- Lipoicum acidum 6X 0.005g;  Cartilago suis
2X  0.0005g;  Embryo suis 2X  0.0005g;  Funiculus  umbilicalis suis 
2X  0.0005g;  Placenta suis  2X  0.0005g.</content>
            </paragraph>
          </text>
          <effectiveTime value="20111018"/>
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          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>PURPOSE</title>
          <text>
            <paragraph>Minor joint pain and stiffness<br/>
            </paragraph>
          </text>
          <effectiveTime value="20111018"/>
        </section>
      </component>
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          <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
          <title>KEEP OUT OF REACH OF CHILDREN</title>
          <text>
            <content styleCode="bold">Keep this and all medicine out of the reach of children.</content>
          </text>
          <effectiveTime value="20111018"/>
        </section>
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          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>INDICATIONS AND USAGE</title>
          <text>For the temporary relief of:<br/>
            <list ID="i607ddfad-7cf3-4386-8bde-f92af452ad4d" listType="unordered">
              <item>Minor joint pain and stiffness<br/>
              </item>
            </list>
          </text>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>WARNINGS</title>
          <text>
            <content styleCode="bold">Warnings: For external use only. </content>Do not apply to large areas of the body. If symptoms persist or worsen, or if a rash develops a physician should be consulted. In rare cases, allergic skin reactions may develop. Avoid using Zeel in cases of known hypersensitivity to any ingredients in Zeel.<br/>
          </text>
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>DOSAGE AND ADMINISTRATION</title>
          <text>
            <content styleCode="bold">Direction for use:</content> Adults: Apply in the morning and evening to the effected areas, rubbing in gently. If appropriate, also apply an ointment dressing. Children under 18 years of age see a doctor.<br/>
          </text>
          <effectiveTime value="20111018"/>
        </section>
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          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>INACTIVE INGREDIENTS</title>
          <text>
            <content styleCode="bold">Inactive ingredients:</content> Cetylstearyl alcohol, ethanol, paraffin, purified water and white petrolatum.<br/>
          </text>
          <effectiveTime value="20111018"/>
        </section>
      </component>
      <component>
        <section>
          <id root="e6db4a03-8c3e-40b0-bc71-1ba924f001a6"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <text>
            <renderMultiMedia referencedObject="M1"/>
            <br/>Zeel 50g Carton.jpg<br/>
          </text>
          <effectiveTime value="20111018"/>
          <component>
            <observationMedia ID="M1" classCode="OBS" moodCode="EVN">
              <text>Zeel 50g Carton.jpg</text>
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