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  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Benadryl 
 <sup>®</sup> EXTRA STRENGTH ITCH COOLING SPRAY
</title>
  <effectiveTime value="20250718"/>
  <setId root="a7eae5dc-9db6-4bdf-9179-76060e75e044"/>
  <versionNumber value="7"/>
  <author>
    <time/>
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        <id extension="118772437" root="1.3.6.1.4.1.519.1"/>
        <name>Kenvue Brands LLC</name>
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          <effectiveTime value="20250718"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="69968-0270" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Benadryl Extra Strength Itch Cooling</name>
                <formCode code="C42989" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SPRAY"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Diphenhydramine Hydrochloride and Zinc Acetate</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <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="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="FZ989GH94E" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POVIDONE, UNSPECIFIED</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="023C2WHX2V" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TROMETHAMINE</name>
                  </ingredientSubstance>
                </ingredient>
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                  <quantity>
                    <numerator unit="mg" value="20"/>
                    <denominator unit="mL" value="1"/>
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                    <code code="TC2D6JAD40" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DIPHENHYDRAMINE HYDROCHLORIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="8GTS82S83M" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>DIPHENHYDRAMINE</name>
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                  <quantity>
                    <numerator unit="mg" value="1"/>
                    <denominator unit="mL" 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>
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                <asContent>
                  <quantity>
                    <numerator unit="mL" value="59"/>
                    <denominator value="1"/>
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                  <containerPackagedProduct>
                    <code code="69968-0270-2" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43175" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, SPRAY"/>
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                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20190401"/>
                      </effectiveTime>
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                    <territorialAuthority>
                      <territory>
                        <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="20200814"/>
        </section>
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        <section>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <effectiveTime value="20200814"/>
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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 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="20200814"/>
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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="20200814"/>
        </section>
      </component>
      <component>
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          <id root="b73588ea-6722-dcb5-e053-2995a90ab0b6"/>
          <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>
            <paragraph>
              <content styleCode="bold">Flammable.</content> Keep away from fire or flame.
      

 </paragraph>
          </text>
          <effectiveTime value="20200814"/>
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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="20200814"/>
            </section>
          </component>
          <component>
            <section>
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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="20200814"/>
            </section>
          </component>
          <component>
            <section>
              <id root="b73588ea-6725-dcb5-e053-2995a90ab0b6"/>
              <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="20200814"/>
            </section>
          </component>
          <component>
            <section>
              <id root="b73588ea-6726-dcb5-e053-2995a90ab0b6"/>
              <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="20200814"/>
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          <component>
            <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="20200814"/>
            </section>
          </component>
        </section>
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        <section>
          <id root="b73588ea-6728-dcb5-e053-2995a90ab0b6"/>
          <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>adults and children 2 years of age and older: spray on 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="20200814"/>
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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="20200814"/>
        </section>
      </component>
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        <section>
          <id root="b73588ea-672a-dcb5-e053-2995a90ab0b6"/>
          <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="20200814"/>
        </section>
      </component>
      <component>
        <section>
          <id root="b73588ea-672b-dcb5-e053-2995a90ab0b6"/>
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          <title>Questions?  </title>
          <text>
            <paragraph>call 
       
 
  <content styleCode="bold">1-800-524-2624</content> (English/Spanish)
      

 </paragraph>
          </text>
          <effectiveTime value="20200814"/>
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          <text>
            <paragraph>Distributed by:</paragraph>
            <paragraph/>
            <paragraph>Kenvue Brands LLC</paragraph>
            <paragraph>Summit, NJ 07901</paragraph>
          </text>
          <effectiveTime value="20250718"/>
        </section>
      </component>
      <component>
        <section ID="id_link_fb2bc5f7-5ca1-6b98-e053-6394a90a5fa0">
          <id root="3a30fbe4-8cd6-6b70-e063-6294a90acdde"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label</title>
          <text>
            <paragraph>Benadryl®</paragraph>
            <paragraph/>
            <paragraph>Relief for most outdoor itches</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">EXTRA STRENGTH</content>
              </content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">ITCH COOLING SPRAY</content>
              </content>
            </paragraph>
            <paragraph/>
            <paragraph>Diphenhydramine HCl 2% / Topical Analgesic</paragraph>
            <paragraph>Zinc acetate 0.1 % / Skin Protectant</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Questions?</paragraph>
            <paragraph>call 
  <content styleCode="bold">1-877-717-2824</content> (toll-free)
 </paragraph>
            <paragraph>or 
  <content styleCode="bold">215-273-8755</content> (collect)
 </paragraph>
            <paragraph>www.benadryl.com</paragraph>
            <table styleCode="Noautorules" width="55%">
              <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>Distributed by:</paragraph>
            <paragraph>Kenvue Brands LLC
  <br/>
Summit, NJ 07901
 </paragraph>
            <paragraph>
              <content styleCode="bold">© </content>Kenvue Brands LLC 2025
 </paragraph>
            <paragraph>
              <content styleCode="bold">Made in Canada</content>
            </paragraph>
            <paragraph>Pat. www.kenvuepats.com</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">2 FL OZ (59 mL)</content>
            </paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_3a30faba-784f-efc2-e063-6394a90a57fd"/>
            </paragraph>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20250718"/>
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              <text>Benadryl_1</text>
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