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            <name>Blairex Laboratories, Inc.</name>
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                        <code code="50486-468" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Zilactin 
<suffix>Early Relief Cold Sore
</suffix>
                        </name>
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                           <genericMedicine>
                              <name>benzyl alcohol</name>
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                              <name>THYMOL</name>
                           </ingredientSubstance>
                        </ingredient>
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                           <ingredientSubstance>
                              <code code="L7T10EIP3A" codeSystem="2.16.840.1.113883.4.9"/>
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                              <denominator unit="g" value="1"/>
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                              <name>BENZYL ALCOHOL</name>
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                              <name>HYDROXYPROPYL CELLULOSE (TYPE M)</name>
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                        </ingredient>
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                              <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PROPYLENE GLYCOL</name>
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                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="O414PZ4LPZ" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SALICYLIC ACID</name>
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                              <code code="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ALCOHOL</name>
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                        </ingredient>
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                           <quantity>
                              <numerator value="7.1" unit="g"/>
                              <denominator value="1"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Drug Facts</content>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20130827"/>
            </section>
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               <title>Active ingredient
</title>
               <text>
                  <paragraph>Benzyl alcohol 10%
</paragraph>
               </text>
               <effectiveTime value="20130827"/>
            </section>
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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>Cold sore/fever blister treatment, Oral pain reliever
</paragraph>
               </text>
               <effectiveTime value="20130827"/>
            </section>
         </component>
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               <title>Use
</title>
               <text>
                  <paragraph>temporarily relieves pain caused by:
</paragraph>
                  <list listType="unordered" styleCode="Square">
                     <item>cold sores/fever blisters
</item>
                     <item>canker sores, mouth sores
</item>
                     <item>gum irritations
</item>
                  </list>
               </text>
               <effectiveTime value="20130827"/>
            </section>
         </component>
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               <title>Warnings
</title>
               <effectiveTime value="20130827"/>
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                     <title>Flammable:
</title>
                     <text>
                        <list listType="unordered" styleCode="Square">
                           <item>keep away from fire or flame
</item>
                        </list>
                     </text>
                     <effectiveTime value="20130827"/>
                  </section>
               </component>
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                  <section ID="s7">
                     <id root="d17aea84-0bb9-8ff1-e053-2a95a90adf21"/>
                     <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
                     <title>Stop use and ask a physician if
</title>
                     <text>
                        <list listType="unordered" styleCode="Square">
                           <item>sore mouth symptoms do not improve in 7 days
</item>
                           <item>condition worsens or symptoms clear up and occur again within a few days
</item>
                           <item>swelling, rash or fever develops
</item>
                           <item>irritation, pain or redness persists or worsens
</item>
                           <item>apply only to affected area
</item>
                           <item>do not exceed recommended dosage
</item>
                           <item>avoid contact with the eyes
</item>
                           <item>do not use for more than 7 days unless directed by a physician or dentist
</item>
                        </list>
                     </text>
                     <effectiveTime value="20130827"/>
                  </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"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Keep out of reach of children</content>. If swallowed, get medical help or contact a poison control center immediately.

        

 </paragraph>
                     </text>
                     <effectiveTime value="20130827"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="s9">
               <id root="d17aea84-0bbb-8ff1-e053-2a95a90adf21"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions
</title>
               <text>
                  <table width="100%">
                     <col width="25.000%" align="left"/>
                     <col width="75.000%" align="left"/>
                     <tbody>
                        <tr>
                           <td align="left" styleCode="Toprule Botrule Rrule" valign="top">adults and children 
          
    
     <br/>2 years and older

         
   
    </td>
                           <td align="left" styleCode="Toprule Botrule" valign="top">dry affected area. Apply with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds.
</td>
                        </tr>
                        <tr>
                           <td align="left" styleCode="Botrule Rrule" valign="top">children under 12 years
</td>
                           <td align="left" styleCode="Botrule" valign="top">adult supervision should be given in the use of this product
</td>
                        </tr>
                        <tr>
                           <td align="left" styleCode="Botrule Rrule" valign="top">children under 2 years
</td>
                           <td align="left" styleCode="Botrule" valign="top">do not use, consult a physician or dentist
</td>
                        </tr>
                     </tbody>
                  </table>
               </text>
               <effectiveTime value="20130827"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Other information
</title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin to film, and immediately wipe the area with a moist gauze pad or tissue.
</item>
                     <item>contains alcohol 68% by volume
</item>
                     <item>store at 15-30°C (59-86°F)
</item>
                  </list>
               </text>
               <effectiveTime value="20130827"/>
            </section>
         </component>
         <component>
            <section ID="s11">
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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>
                  <paragraph>boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 37, tannic acid
</paragraph>
                  <paragraph>Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA
</paragraph>
               </text>
               <effectiveTime value="20130827"/>
            </section>
         </component>
         <component>
            <section ID="s12">
               <id root="d17aea84-0bbe-8ff1-e053-2a95a90adf21"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <text>
                  <paragraph>
                     <renderMultiMedia ID="f01" referencedObject="mm01"/>Questions or Comments?
       
 
  <br/>Call TOLL FREE 1-800-252-4739
       
 
  <br/>www.zilactin.com

      

 </paragraph>
               </text>
               <effectiveTime value="20130827"/>
               <component>
                  <observationMedia ID="mm01">
                     <text>Telephone
</text>
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            <section ID="s13">
               <id root="d17aea84-0bbf-8ff1-e053-2a95a90adf21"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <text>
                  <paragraph>PROMOTES HEALING
</paragraph>
                  <paragraph>Cold Sore/Fever Blister/Oral Pain Treatment
</paragraph>
                  <paragraph>Zilactin
       
 
  <sup>®</sup> Early Relief Cold Sore Gel

      

 </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>Bioadhesive Promotes Healing
</item>
                     <item>Relieves Pain for up to 6 Hours
</item>
                  </list>
                  <paragraph>Net wt. 0.25 oz (7.1g)
</paragraph>
                  <renderMultiMedia ID="f02" referencedObject="mm02"/>
               </text>
               <effectiveTime value="20130827"/>
               <component>
                  <observationMedia ID="mm02">
                     <text>Principal Display Panel
</text>
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                        <reference value="zil01-0002-02.jpg"/>
                     </value>
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               </component>
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