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  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Benadryl 
 <sub>®</sub> ORIGINAL STRENGTH ITCH STOPPING CREAM
</title>
  <effectiveTime value="20241126"/>
  <setId root="920c50cb-9bdd-4a36-bb3d-c2559db73327"/>
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  <author>
    <time/>
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        <name>Kenvue Brands LLC</name>
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          <effectiveTime value="20241126"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="69968-0625" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Benadryl Original Strength Itch Stopping</name>
                <formCode code="C28944" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CREAM"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Diphenhydramine Hydrochloride and Zinc Acetate</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
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                    <code code="936JST6JCN" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CETYL ALCOHOL</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="H5RIZ3MPW4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DIAZOLIDINYL UREA</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="A2I8C7HI9T" codeSystem="2.16.840.1.113883.4.9"/>
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                </ingredient>
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                    <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
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                    <code code="Z8IX2SC1OH" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PROPYLPARABEN</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
                  </ingredientSubstance>
                </ingredient>
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                    <numerator unit="mg" value="10"/>
                    <denominator unit="g" value="1"/>
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                    <code code="TC2D6JAD40" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DIPHENHYDRAMINE HYDROCHLORIDE</name>
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                        <code code="8GTS82S83M" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>DIPHENHYDRAMINE</name>
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                    </activeMoiety>
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                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="1"/>
                    <denominator unit="g" value="1"/>
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                    <code code="FM5526K07A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ZINC ACETATE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="13S1S8SF37" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>ZINC CATION</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
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                  <quantity>
                    <numerator unit="g" value="28.3"/>
                    <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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                        <numerator unit="1" value="1"/>
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                          <statusCode code="active"/>
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                            <low value="20200131"/>
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                    <territorialAuthority>
                      <territory>
                        <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">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20221104"/>
        </section>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <effectiveTime value="20221104"/>
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              <text>
                <table width="65%">
                  <col align="left" valign="top" width="75%"/>
                  <col align="left" valign="top" width="25%"/>
                  <thead>
                    <tr>
                      <th>
                        <content styleCode="italics">Active ingredients</content>
                      </th>
                      <th>
                        <content styleCode="italics">Purpose</content>
                      </th>
                    </tr>
                  </thead>
                  <tbody>
                    <tr>
                      <td>Diphenhydramine hydrochloride 1%</td>
                      <td>Topical analgesic</td>
                    </tr>
                    <tr>
                      <td>Zinc acetate 0.1%</td>
                      <td>Skin protectant</td>
                    </tr>
                  </tbody>
                </table>
              </text>
              <effectiveTime value="20200731"/>
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        </section>
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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:</item>
              <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>
          </text>
          <effectiveTime value="20200731"/>
        </section>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <text>
            <paragraph styleCode="bold">For external use only.</paragraph>
          </text>
          <effectiveTime value="20200731"/>
          <component>
            <section>
              <id root="eca12813-7ef9-5db5-e053-2995a90aa4a5"/>
              <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" 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="20200731"/>
            </section>
          </component>
          <component>
            <section>
              <id root="eca12813-7efa-5db5-e053-2995a90aa4a5"/>
              <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" styleCode="Square">
                  <item>on chicken pox</item>
                  <item>on measles</item>
                </list>
              </text>
              <effectiveTime value="20200731"/>
            </section>
          </component>
          <component>
            <section>
              <id root="eca12813-7efb-5db5-e053-2995a90aa4a5"/>
              <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="20200731"/>
            </section>
          </component>
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              <id root="eca12813-7efc-5db5-e053-2995a90aa4a5"/>
              <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" styleCode="Square">
                  <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="20200731"/>
            </section>
          </component>
          <component>
            <section>
              <id root="eca12813-7efd-5db5-e053-2995a90aa4a5"/>
              <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="20200731"/>
            </section>
          </component>
        </section>
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          <id root="eca12813-7efe-5db5-e053-2995a90aa4a5"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <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="20200731"/>
        </section>
      </component>
      <component>
        <section>
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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" styleCode="Square">
              <item>protect from excessive heat (40°C/104°F)</item>
            </list>
          </text>
          <effectiveTime value="20200731"/>
        </section>
      </component>
      <component>
        <section>
          <id root="eca12813-7f00-5db5-e053-2995a90aa4a5"/>
          <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="20200731"/>
        </section>
      </component>
      <component>
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          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions?</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>
          <effectiveTime value="20221104"/>
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          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <text>
            <paragraph>Distributed by:
  <br/>
              <content styleCode="bold">Kenvue Brands LLC </content>
              <br/>
Summit, NJ 07901
  <br/>
            </paragraph>
          </text>
          <effectiveTime value="20241126"/>
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      </component>
      <component>
        <section ID="id_link_eca16cc6-fffa-11ac-e053-2995a90acd48">
          <id root="27cdd95f-6e54-7241-e063-6394a90a5f12"/>
          <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>Benadryl
  <sup>®</sup>
              <sub>®</sub>
            </paragraph>
            <paragraph/>
            <paragraph>THE HISTAMINE BLOCKER 
  <sub>TM</sub>
            </paragraph>
            <paragraph/>
            <paragraph>Relief from most outdoor itches</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">ORIGINAL STRENGTH</content>
            </paragraph>
            <paragraph/>
            <paragraph>For Ages 2+</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">ITCH STOPPING</content>
            </paragraph>
            <paragraph>
              <content styleCode="italics">CREAM</content>
            </paragraph>
            <paragraph/>
            <paragraph>Diphenhydramine HCl 1%/</paragraph>
            <paragraph>Topical Analgesic</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Zinc acetate 0.1% /</paragraph>
            <paragraph>Skin Protectant</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Insect Bites</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Poison Ivy,</paragraph>
            <paragraph>Oak, Sumac</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Mosquito</paragraph>
            <paragraph>Bites</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Sunburn</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Minor Cuts</paragraph>
            <paragraph>&amp; Scrapes</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>NET WT. 1 OZ (28.3g)</paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_27cdbe22-b38a-30dd-e063-6394a90a4791"/>
            </paragraph>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20241126"/>
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              <text>Benadryl_1</text>
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