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  <title>Benadryl 
 <sup>®</sup> EXTRA STRENGTH ITCH RELIEF STICK
</title>
  <effectiveTime value="20250710"/>
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    <time/>
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          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="69968-0459" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Benadryl Extra Strength Itch Relief</name>
                <formCode code="C42986" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SOLUTION"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>DIPHENHYDRAMINE HYDROCHLORIDE and Zinc Acetate</name>
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                    <code code="FM5526K07A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ZINC ACETATE</name>
                    <activeMoiety>
                      <activeMoiety>
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                        <name>ZINC CATION</name>
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                    </activeMoiety>
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                <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"/>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="FZ989GH94E" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POVIDONE, UNSPECIFIED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
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                </ingredient>
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                    <code code="023C2WHX2V" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TROMETHAMINE</name>
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                    <numerator unit="mg" value="20"/>
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                    <code code="TC2D6JAD40" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DIPHENHYDRAMINE HYDROCHLORIDE</name>
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                        <name>DIPHENHYDRAMINE</name>
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                    <numerator unit="mL" value="14"/>
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                          <statusCode code="active"/>
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                            <low value="20190601"/>
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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="20190128"/>
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          <effectiveTime value="20190128"/>
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              <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
              <text>
                <table width="55%">
                  <col align="left" valign="top" width="80%"/>
                  <col align="left" valign="top" width="20%"/>
                  <thead>
                    <tr>
                      <th>
                        <content styleCode="italics">Active ingredient</content>
                      </th>
                      <th>
                        <content styleCode="italics">Purpose</content>
                      </th>
                    </tr>
                  </thead>
                  <tbody>
                    <tr>
                      <td>Diphenhydramine HCl 2%</td>
                      <td>Topical analgesic </td>
                    </tr>
                    <tr>
                      <td>Zinc acetate 0.1%</td>
                      <td>Skin protectant </td>
                    </tr>
                  </tbody>
                </table>
              </text>
              <effectiveTime value="20190128"/>
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          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <list listType="unordered">
              <item>temporarily relieves pain and itching associated with:
        
  
   <list listType="unordered">
                  <item>insect bites</item>
                  <item>minor burns</item>
                  <item>sunburn</item>
                  <item>minor skin irritations</item>
                  <item>minor cuts</item>
                  <item>scrapes</item>
                  <item>rashes due to poison ivy, poison oak, and poison sumac</item>
                  <item>dries the oozing and weeping of poison ivy, poison oak and poison sumac</item>
                </list>
              </item>
            </list>
          </text>
          <effectiveTime value="20190128"/>
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          <title>Warnings</title>
          <text>
            <paragraph>
              <content styleCode="bold">For external use only.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Flammable.</content> Keep away from fire or flame.
      

 </paragraph>
          </text>
          <effectiveTime value="20190128"/>
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              <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
              <title>Do not use</title>
              <text>
                <list listType="unordered">
                  <item>on large areas of the body</item>
                  <item>with any other product containing diphenhydramine, even one taken by mouth</item>
                </list>
              </text>
              <effectiveTime value="20190128"/>
            </section>
          </component>
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            <section>
              <id root="ba07375c-a909-f53b-e053-2995a90abf8f"/>
              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <title>Ask a doctor before use</title>
              <text>
                <list listType="unordered">
                  <item>on chicken pox</item>
                  <item>on measles</item>
                </list>
              </text>
              <effectiveTime value="20190128"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ba07375c-a90a-f53b-e053-2995a90abf8f"/>
              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">When using this product</content> avoid contact with eyes
        

 </paragraph>
              </text>
              <effectiveTime value="20190128"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ba07375c-a90b-f53b-e053-2995a90abf8f"/>
              <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
              <title>Stop use and ask a doctor if</title>
              <text>
                <list listType="unordered">
                  <item>condition worsens or does not improve within 7 days</item>
                  <item>symptoms persist for more than 7 days or clear up and occur again within a few days</item>
                </list>
              </text>
              <effectiveTime value="20190128"/>
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            <section>
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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 right away.
        

 </paragraph>
              </text>
              <effectiveTime value="20190128"/>
            </section>
          </component>
        </section>
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <list listType="unordered">
              <item>do not use more than directed</item>
              <item>hold stick straight down over affected skin area</item>
              <item>press tip of stick repeatedly on affected skin area until liquid flows, then dab sparingly </item>
              <item>adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily</item>
              <item>children under 2 years of age: ask a doctor</item>
            </list>
          </text>
          <effectiveTime value="20190128"/>
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          <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
          <title>Other information  </title>
          <text>
            <list listType="unordered">
              <item>store at 20° to 25° C (68° to 77° F)</item>
            </list>
          </text>
          <effectiveTime value="20190128"/>
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      </component>
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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>alcohol, glycerin, PVP, purified water, tromethamine</paragraph>
          </text>
          <effectiveTime value="20231006"/>
        </section>
      </component>
      <component>
        <section ID="id_link_070d6246-fa20-f251-e063-6294a90a1902">
          <id root="3990a151-bcf9-3bcd-e063-6294a90a0000"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions or comments?</title>
          <text>
            <paragraph>call 
  <content styleCode="bold">1-877-717-2824</content> (toll-free) or 215-273-8755 (collect) 
  <content styleCode="bold">www.benadryl.com</content>
            </paragraph>
          </text>
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          <text>
            <paragraph>Distributed by:
  <br/>
            </paragraph>
            <paragraph>Kenvue Brands LLC
  <br/>
Summit, NJ 07901
  <br/>
            </paragraph>
          </text>
          <effectiveTime value="20250710"/>
        </section>
      </component>
      <component>
        <section ID="id_link_070d7057-accf-3d09-e063-6394a90a768c">
          <id root="3990b55c-2dab-21be-e063-6394a90a505e"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL - 14 mL Applicator Carton</title>
          <text>
            <paragraph>
              <content styleCode="bold">Benadryl
   <sup>®</sup>
                <sub>®</sub>
              </content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Apply directly</paragraph>
            <paragraph>to insect bites</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">EXTRA STRENGTH</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">For Ages 2+</content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">ITCH</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">RELIEF</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">STICK</content>
              </content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Diphenhydramine HCL 2% /</paragraph>
            <paragraph>Topical Analgesic</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph>Zinc acetate 0.1% /</paragraph>
            <paragraph>Skin Protectant</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Starts working</paragraph>
            <paragraph>on contact</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Relieves itch</paragraph>
            <paragraph>and pain</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Insect Mosquito</paragraph>
            <paragraph>Bites Bites</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>0.47 FL OZ (14mL)</paragraph>
            <paragraph>
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            <paragraph/>
          </text>
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