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  <title>Benadryl 
 <sup>®</sup> EXTRA STRENGTH ITCH STOPPING GEL
</title>
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        <name>Kenvue Brands LLC</name>
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                <code code="69968-0242" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Benadryl Extra Strength Itch Stopping</name>
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                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Diphenhydramine Hydrochloride</name>
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                </ingredient>
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                    <code code="2968PHW8QP" codeSystem="2.16.840.1.113883.4.9"/>
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                    <code code="3NXW29V3WO" codeSystem="2.16.840.1.113883.4.9"/>
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                    <code code="1Q73Q2JULR" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM CITRATE, UNSPECIFIED FORM</name>
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                </ingredient>
                <ingredient classCode="ACTIB">
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                    <numerator unit="mg" value="20"/>
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                    <numerator unit="mL" value="103"/>
                    <denominator value="1"/>
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                        <low value="20131001"/>
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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>
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          <effectiveTime value="20160909"/>
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          <title>Active ingredient</title>
          <text>
            <paragraph>Diphenhydramine HCl 2%</paragraph>
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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>Topical Analgesic</paragraph>
          </text>
          <effectiveTime value="20230630"/>
        </section>
      </component>
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          <title>Use</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 cuts</item>
                  <item>scrapes</item>
                  <item>minor skin irritations</item>
                  <item>rashes due to poison ivy, poison oak, and poison sumac</item>
                </list>
              </item>
            </list>
          </text>
          <effectiveTime value="20160909"/>
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          <title>Warnings</title>
          <text>
            <paragraph>
              <content styleCode="bold">For external use only.</content>
            </paragraph>
          </text>
          <effectiveTime value="20160909"/>
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              <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="20160909"/>
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              <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="20160909"/>
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              <text>
                <paragraph>
                  <content styleCode="bold">When using this product</content> avoid contact with eyes
        

 </paragraph>
              </text>
              <effectiveTime value="20160909"/>
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              <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 </item>
                  <item>symptoms persist for more than 7 days or clear up and occur again within a few days</item>
                </list>
              </text>
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              <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="20160909"/>
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          <title>Directions</title>
          <text>
            <list listType="unordered">
              <item>do not use more  than directed </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="20160909"/>
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          <title>Other information </title>
          <text>
            <paragraph>Store at Room Temperature</paragraph>
          </text>
          <effectiveTime value="20160909"/>
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      </component>
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        <section>
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          <title>Inactive ingredients </title>
          <text>
            <paragraph>SD alcohol 38-B, camphor, citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose,  methylparaben, propylene glycol, propylparaben, purified water, sodium citrate</paragraph>
          </text>
          <effectiveTime value="20160909"/>
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          <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 
  <content styleCode="bold">215-273-8755</content> (collect) www.benadryl.com
 </paragraph>
          </text>
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          <text>
            <paragraph>Distributed by:
  <br/>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Kenvue Brands LLC </content>
              <br/>
Summit, NJ 07901
 </paragraph>
          </text>
          <effectiveTime value="20250424"/>
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      </component>
      <component>
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          <id root="33855a8b-4f55-8c27-e063-6394a90a9b2a"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL - 103 mL Tube Label</title>
          <text>
            <paragraph>
              <content styleCode="bold">Benadryl®</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">®</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Cooling relief for</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">most outdoor itches</content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">EXTRA STRENGTH</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">For Skin Use Only</content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">ITCH STOPPING</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">GEL</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Diphenhydramine HCl 2% /</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Topical Analgesic</content>
            </paragraph>
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              <colgroup>
                <col align="left" valign="top" width="15%"/>
                <col align="left" valign="top" width="25%"/>
                <col align="left" valign="top" width="19%"/>
                <col align="left" valign="top" width="18%"/>
                <col align="left" valign="top" width="23%"/>
              </colgroup>
              <tbody>
                <tr>
                  <td>
                    <content styleCode="bold">Insect
      <br/>
                      <br/>
			Bites 
     </content>
                  </td>
                  <td>
                    <content styleCode="bold">Poison Ivy,
      <br/>
                      <br/>
			Oak, Sumac 
     </content>
                  </td>
                  <td>
                    <content styleCode="bold">Mosquito
      <br/>
                      <br/>
			Bites 
     </content>
                  </td>
                  <td>
                    <content styleCode="bold">Sunburn</content>
                  </td>
                  <td>
                    <content styleCode="bold">Minor Cuts
      <br/>
                      <br/>&amp; Scrapes 
     </content>
                  </td>
                </tr>
              </tbody>
            </table>
            <paragraph>
              <content styleCode="bold">3.5 FL OZ (103 mL)</content>
            </paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_33855684-5c83-8c25-e063-6394a90a7d9b"/>
            </paragraph>
            <paragraph/>
          </text>
          <effectiveTime value="20250424"/>
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              <text>Benadryl_1</text>
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