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  <title>Benadryl 
 <sup>®</sup> EXTRA STRENGTH ITCH STOPPING CREAM
</title>
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        <name>Kenvue Brands LLC</name>
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          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="69968-0223" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Benadryl Extra Strength<suffix>Itch Stopping</suffix>
                </name>
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                    <name>Diphenhydramine Hydrochloride and Zinc Acetate</name>
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                        <name>ZINC CATION</name>
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                    <numerator unit="g" value="28.3"/>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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              <consumedIn>
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          <text>
            <paragraph>
              <content styleCode="bold">Drug Facts</content>
            </paragraph>
          </text>
          <effectiveTime value="20221104"/>
        </section>
      </component>
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          <effectiveTime value="20181120"/>
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              <text>
                <table width="70%">
                  <col align="left" valign="top" width="60%"/>
                  <col align="left" valign="top" width="40%"/>
                  <thead>
                    <tr>
                      <th>Active ingredients</th>
                      <th>Purpose</th>
                    </tr>
                  </thead>
                  <tbody>
                    <tr>
                      <td>Diphenhydramine hydrochloride 2%</td>
                      <td>Topical analgesic</td>
                    </tr>
                    <tr>
                      <td>Zinc acetate 0.1%</td>
                      <td>Skin protectant</td>
                    </tr>
                  </tbody>
                </table>
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              <effectiveTime value="20181120"/>
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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" styleCode="Square">
              <item>temporarily relieves pain and itching associated with:
        
  
   <list listType="unordered" styleCode="Square">
                  <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>
                </list>
              </item>
              <item>dries the oozing and weeping of poison ivy, poison oak, and poison sumac</item>
            </list>
          </text>
          <effectiveTime value="20181120"/>
        </section>
      </component>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <text>
            <paragraph>
              <content styleCode="bold">For external use only.</content>
            </paragraph>
          </text>
          <effectiveTime value="20221104"/>
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              <text>
                <paragraph>
                  <content styleCode="bold">Do not use</content>
                </paragraph>
                <list listType="unordered" styleCode="Square">
                  <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="20221104"/>
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              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Ask a doctor before use</content>
                </paragraph>
                <list listType="unordered" styleCode="Square">
                  <item>on chicken pox</item>
                  <item>on measles</item>
                </list>
              </text>
              <effectiveTime value="20221104"/>
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              <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="20221104"/>
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              <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Stop use and ask a doctor if</content>
                </paragraph>
                <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>
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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="20221104"/>
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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>
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          <title>Other information</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>protect from excessive heat (40˚C/104˚F)</item>
            </list>
          </text>
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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>cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water</paragraph>
          </text>
          <effectiveTime value="20181120"/>
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          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>
            <content styleCode="bold">Questions or comments?</content>
          </title>
          <text>
            <paragraph>ca
  <content styleCode="bold">l</content>l 1-877-717-2824 tol
  <content styleCode="bold">l</content>-free or 215-273-8755 (co
  <content styleCode="bold">l</content>lect) www.benadryl.com
 </paragraph>
          </text>
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          <text>
            <paragraph>Distributed by:</paragraph>
            <paragraph>
              <content styleCode="bold">Kenvue Brands LLC.</content>
              <br/>
Summit, NJ 07901
  <br/>
            </paragraph>
          </text>
          <effectiveTime value="20241119"/>
        </section>
      </component>
      <component>
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          <id root="26b4cf85-2266-c90f-e063-6394a90a2c39"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton</title>
          <text>
            <paragraph>
              <content styleCode="bold">Benadryl®
   <sub> ®</sub>
              </content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>THE HISTAMINE</paragraph>
            <paragraph>BLOCKER
  <sub>TM</sub>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph>Relief from most outdoor itches</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">EXTRA STRENGTH</content>
            </paragraph>
            <paragraph/>
            <paragraph>For Ages 2+</paragraph>
            <paragraph>
              <content styleCode="bold">ITCH STOPPING</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">CREAM</content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Diphenhydramine HCl 2%</paragraph>
            <paragraph>/ Topical Analgesic</paragraph>
            <paragraph>Zinc acetate 0.1% / Skin</paragraph>
            <paragraph>Protectant</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Insect Bites</content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Poison Ivy,</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Oak, Sumac</content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Mosquito</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Bites</content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Sunburn</content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Minor Cuts</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">&amp; Scrapes</content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">NET WT.1 OZ (28.3g)</content>
            </paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_26b4b22c-2ad2-c7f3-e063-6394a90ac41b"/>
            </paragraph>
            <paragraph/>
          </text>
          <effectiveTime value="20241112"/>
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              <text>Benadryl</text>
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