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                <caption>•</caption>take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)</item>
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                <caption>•</caption>apply more or for longer than directed</item>
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              <content styleCode="bold">Heart attack and stroke warning:</content> NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.</paragraph>
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            <section ID="ID_5859a724-88a9-4c5e-9b32-a2a9fa7cc67b">
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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>
                    <caption>•</caption>if you have ever had an allergic reaction to any other pain reliever or to a fever reducer</item>
                  <item>
                    <caption>•</caption>for strains, sprains, bruises or sports injuries.  This product has not been shown to work for these types of injuries.</item>
                  <item>
                    <caption>•</caption>right before or after heart surgery</item>
                  <item>
                    <caption>•</caption>on more than 2 body areas at the same time</item>
                  <item>
                    <caption>•</caption>in the eyes, nose or mouth</item>
                </list>
              </text>
              <effectiveTime value="20240301"/>
            </section>
          </component>
          <component>
            <section ID="ID_6231d52c-8d7a-45c1-aa11-8feeb4ca77a7">
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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 if </title>
              <text>
                <list listType="unordered">
                  <item>
                    <caption>•</caption>you have problems or serious side effects from taking pain relievers or fever reducers</item>
                  <item>
                    <caption>•</caption>stomach bleeding warning applies to you</item>
                  <item>
                    <caption>•</caption>you have a history of stomach problems, such as heartburn</item>
                  <item>
                    <caption>•</caption>you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke</item>
                  <item>
                    <caption>•</caption>you are taking a diuretic</item>
                  <item>
                    <caption>•</caption>you are under age 18 years.  It is not known if this drug works or is safe in children under age 18 years.</item>
                </list>
              </text>
              <effectiveTime value="20240301"/>
            </section>
          </component>
          <component>
            <section ID="ID_fce0186a-0ca5-44b8-a730-faa70afdbf44">
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              <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
              <title>Ask a doctor or pharmacist before use if you are </title>
              <text>
                <list listType="unordered">
                  <item>
                    <caption>•</caption>under a doctor’s care for any serious condition</item>
                  <item>
                    <caption>•</caption>taking any other drug</item>
                </list>
              </text>
              <effectiveTime value="20240301"/>
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              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <title>When using this product </title>
              <text>
                <list listType="unordered">
                  <item>
                    <caption>•</caption>avoid contact with eyes, nose, or mouth</item>
                  <item>
                    <caption>•</caption>if eye contact occurs, rinse thoroughly with water</item>
                </list>
              </text>
              <effectiveTime value="20240301"/>
            </section>
          </component>
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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>
                    <caption>•</caption>pain gets worse or lasts more than 21 days</item>
                  <item>
                    <caption>•</caption>redness or swelling is present in the painful area</item>
                  <item>
                    <caption>•</caption>fever occurs</item>
                  <item>
                    <caption>•</caption>skin irritation occurs</item>
                  <item>
                    <caption>•</caption>any new symptoms appear.  These could be signs of a serious condition.</item>
                  <item>
                    <caption>•</caption>you experience any of the following signs of stomach bleeding:<list listType="unordered">
                      <item>
                        <caption>o</caption>feel faint </item>
                      <item>
                        <caption>o</caption>have bloody or black stools </item>
                      <item>
                        <caption>o</caption>vomit blood</item>
                      <item>
                        <caption>o</caption>have stomach pain that does not get better</item>
                    </list>
                  </item>
                  <item>
                    <caption>•</caption>you have symptoms of heart problems or stroke:<list listType="unordered">
                      <item>
                        <caption>o</caption>chest pain</item>
                      <item>
                        <caption>o</caption>trouble breathing</item>
                      <item>
                        <caption>o</caption>leg swelling</item>
                      <item>
                        <caption>o</caption>weakness in one part or side of body</item>
                      <item>
                        <caption>o</caption>slurred speech</item>
                    </list>
                  </item>
                </list>
              </text>
              <effectiveTime value="20240301"/>
            </section>
          </component>
          <component>
            <section ID="ID_872325dc-5fa7-47fb-9281-126d4ef34ee2">
              <id root="6bef8959-876e-4865-8f82-a1573f47eb8e"/>
              <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
              <title>If pregnant or breast-feeding, </title>
              <text>
                <paragraph>ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. </paragraph>
              </text>
              <effectiveTime value="20240301"/>
            </section>
          </component>
          <component>
            <section ID="ID_51c44ad2-f673-4a4d-ac0d-88506402f433">
              <id root="3fdc0ede-eacc-47fc-8624-e5233f06f26d"/>
              <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
              <title>Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  </title>
              <effectiveTime value="20210630"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="ID_2c27e7ee-a17b-431d-aa73-a3badeb6c2d8">
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>
            <content styleCode="italics">Directions</content>
          </title>
          <text>
            <paragraph>Use up to 21 days unless directed by your doctor</paragraph>
            <paragraph>Not for strains, sprains, bruises, or sports injuries.  This product has not been shown to work for these types of injuries.</paragraph>
            <table width="97.76%">
              <col width="43%"/>
              <col width="55%"/>
              <tbody>
                <tr>
                  <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                    <paragraph>
                      <content styleCode="bold">Daily</content>
                    </paragraph>
                  </td>
                  <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                    <paragraph>
                      <content styleCode="bold">Per Dose</content>
                    </paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Lrule " valign="top">
                    <paragraph>
                      <content styleCode="bold">For your arthritis pain:</content>
                    </paragraph>
                    <list listType="unordered">
                      <item>
                        <caption> </caption>• Use 4 times per day every day</item>
                      <item>
                        <caption> </caption>• Do not use on more than 2 body<br/>  areas at the same time</item>
                    </list>
                  </td>
                  <td styleCode="Rrule Lrule " valign="top">
                    <paragraph>
                      <content styleCode="bold">Use ENCLOSED DOSING CARD to measure a dose</content>
                    </paragraph>
                    <list listType="unordered">
                      <item>
                        <caption> </caption>• For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams)</item>
                      <item>
                        <caption> </caption>• For each lower body area (foot, ankle or knee) – Squeeze out 4.5 inches (4 grams)</item>
                    </list>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule Lrule " valign="top"/>
                  <td styleCode="Rrule Botrule Lrule " valign="top"/>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20250211"/>
        </section>
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          <code code="59845-8" codeSystem="2.16.840.1.113883.6.1" displayName="INSTRUCTIONS FOR USE SECTION"/>
          <title>Read the enclosed <content styleCode="underline">User Guide</content> for complete instructions: </title>
          <text>
            <list listType="unordered">
              <item>
                <caption>•</caption>use only as directed</item>
              <item>
                <caption>•</caption>do not use more than directed or for longer than directed</item>
              <item>
                <caption>•</caption>apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes</item>
              <item>
                <caption>•</caption>do not apply in same area as any other product</item>
              <item>
                <caption>•</caption>do not apply with external heat such as heating pad</item>
              <item>
                <caption>•</caption>do not apply a bandage over the treated area</item>
              <item>
                <caption>•</caption>store ENCLOSED DOSING CARD with your Voltaren Arthritis Pain.  The dosing card is <br/>re-usable.</item>
            </list>
          </text>
          <effectiveTime value="20240301"/>
        </section>
      </component>
      <component>
        <section ID="ID_28d24b98-f6e2-41af-85b4-ce491ae7f5a8">
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          <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
          <title>
            <content styleCode="italics">Other information</content>
          </title>
          <text>
            <list listType="unordered">
              <item>
                <caption>•</caption>store at 20-25°C (68-77°F). Keep from freezing.</item>
              <item>
                <caption>•</caption>read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.</item>
            </list>
          </text>
          <effectiveTime value="20240301"/>
        </section>
      </component>
      <component>
        <section ID="ID_4af9443e-9bf2-4b44-a156-9f279dde43c7">
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          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="italics">Inactive ingredients</content>
          </title>
          <text>
            <paragraph>carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution</paragraph>
          </text>
          <effectiveTime value="20240301"/>
        </section>
      </component>
      <component>
        <section ID="ID_7ea03d25-f95c-408f-849c-b796631b375b">
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          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>
            <content styleCode="italics">Questions or comments?</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">1-855-297-3031    www.voltarengel.com</content>
            </paragraph>
          </text>
          <effectiveTime value="20250211"/>
        </section>
      </component>
      <component>
        <section ID="ID_6c284854-6f45-41b3-8219-206018501d38">
          <id root="04203022-c8af-4bd1-919b-ea21ddba675b"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>Additional Information </title>
          <text>
            <paragraph>
              <content styleCode="bold">ORIGINAL PRESCRIPTION STRENGTH</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Medicated Gel Clinically Proven to Relieve Arthritis Pain</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">TREATMENT AREAS</content>
            </paragraph>
            <list listType="unordered">
              <item>
                <caption> </caption>
                <content styleCode="bold">Hand Wrist Elbow Foot Ankle Knee</content>
              </item>
              <item>
                <caption> </caption>Not for use on any other body area (such as back, hip, or shoulder)</item>
            </list>
            <paragraph>
              <content styleCode="bold">Use Enclosed Dosing Card to Measure a Dose</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Voltaren ARTHRITIS PAIN</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">diclofenac sodium topical gel, 1% (NSAID) – arthritis pain reliever</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Dosing Card (NOT ACTUAL SIZE)</content>
            </paragraph>
            <paragraph>Read product User Guide before use</paragraph>
            <paragraph>Not for immediate pain relief</paragraph>
            <paragraph>
              <content styleCode="bold">Upper body dose</content> 2.25 inches long (2 grams)</paragraph>
            <paragraph>
              <content styleCode="bold">Lower body dose </content>4.5 inches long (4 grams)</paragraph>
            <paragraph>
              <content styleCode="bold">How to Use:</content>
            </paragraph>
            <list listType="unordered">
              <item>
                <caption>▪</caption>For arthritis pain <content styleCode="underline">only</content>
              </item>
              <item>
                <caption>▪</caption>Use 4 times a day</item>
              <item>
                <caption>▪</caption>May take up to 7 days to work for your arthritis pain</item>
              <item>
                <caption>▪</caption>For use on no more than 2 body areas</item>
              <item>
                <caption>▪</caption>Use up to 21 days unless directed by your doctor</item>
              <item>
                <caption> </caption>
                <content styleCode="bold">Screw Cap Tamper evident statement: Do not use if safety seal on tube nozzle is broken or missing.</content>
              </item>
              <item>
                <caption> </caption>
                <content styleCode="bold">Flip Cap Tamper evident statement: Do not use if plastic safety seals on sides of cap are broken or missing.</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20250211"/>
        </section>
      </component>
      <component>
        <section ID="ID_d57af9f9-3da6-4b60-a6d7-e0485d415620">
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          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>Principal Display Panel (50 g) </title>
          <text>
            <paragraph>
              <content styleCode="bold">Voltaren </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ARTHRITIS PAIN</content>
            </paragraph>
            <paragraph>diclofenac sodium topical gel, 1% (<content styleCode="bold">NSAID</content>) - arthritis pain reliever</paragraph>
            <paragraph>ANTI-INFLAMMATORY</paragraph>
            <paragraph>For Daily Treatment of Arthritis Pain</paragraph>
            <paragraph>For external use only</paragraph>
            <paragraph>
              <content styleCode="bold">NET WT 50 g (1.76 oz)</content>
            </paragraph>
            <renderMultiMedia ID="id-347559893" referencedObject="BBBA3F61-A39C-4069-A3BE-AA93E5592C3C"/>
          </text>
          <effectiveTime value="20250211"/>
          <component>
            <observationMedia ID="BBBA3F61-A39C-4069-A3BE-AA93E5592C3C">
              <text>Voltaren gel 50 g</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="Voltaren gel 50 g.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
      <component>
        <section ID="ID_10edb437-9d1e-484a-9bca-f03a431ffa58">
          <id root="8fa904e6-1c03-478a-a634-4fdeee3806fb"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>Principal Display Panel (150 g + 150 g + 50 g)</title>
          <text>
            <paragraph>
              <content styleCode="bold">ORIGINAL PRESCRIPTION STRENGTH</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Voltaren </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ARTHRITIS PAIN</content>
            </paragraph>
            <paragraph>diclofenac sodium topical gel, 1% (<content styleCode="bold">NSAID</content>) - arthritis pain reliever</paragraph>
            <paragraph>ANTI-INFLAMMATORY</paragraph>
            <paragraph>For Daily Treatment of Arthritis Pain</paragraph>
            <paragraph>Medicated Gel Clinically Proven to Relieve Arthritis Pain</paragraph>
            <paragraph>NEW FLIP TOP CAP*</paragraph>
            <paragraph>*Cap for 150 g only</paragraph>
            <paragraph>
              <content styleCode="bold">For external use only</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">TREATMENT AREAS</content>
            </paragraph>
            <list listType="unordered">
              <item>
                <caption> </caption>
                <content styleCode="bold">Hand Wrist Elbow Foot Ankle Knee</content>
              </item>
              <item>
                <caption> </caption>
                <content styleCode="bold">Not for use on any other body area (such as back, hip, or shoulder)</content>
              </item>
              <item>
                <caption> </caption>
                <content styleCode="bold">3 TUBES: 150 g + 150 g + 50 g TOTAL NET WT 350 g (12.34 oz)</content>
              </item>
            </list>
            <renderMultiMedia ID="id271596660" referencedObject="F634C9F7-AF33-46C6-850B-874BDC71B337"/>
          </text>
          <effectiveTime value="20250211"/>
          <component>
            <observationMedia ID="F634C9F7-AF33-46C6-850B-874BDC71B337">
              <text>204419 Voltaren Arthritis Pain 350g (12.34 oz) backercard</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="204419 Voltaren Arthritis Pain 350g (12.34 oz)backercard.jpg.jpg"/>
              </value>
            </observationMedia>
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        </section>
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        <section ID="ID_99bd516b-cf0f-452e-8bb6-f890ba62b201">
          <id root="8665e55e-b5e6-4bf7-92b5-a1a0dfc05cbb"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>Principal Display Panel (100 g + 20 g) </title>
          <text>
            <paragraph>
              <content styleCode="bold">FREE 20 g* TRAVEL SIZE</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">*WITH PURCHASE OF 100 g TUBE</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ORIGINAL PRESCRIPTION STRENGTH</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Voltaren</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ARTHRITIS PAIN</content>
            </paragraph>
            <paragraph>Diclofenac sodium topical gel, 1% (<content styleCode="bold">NSAID</content>) arthritis pain reliever</paragraph>
            <paragraph>ANTI-INFLAMMATORY</paragraph>
            <paragraph>For Daily Treatment of Arthritis Pain</paragraph>
            <paragraph>FLIP-TOP CAP†</paragraph>
            <paragraph>†Cap for 100 g only</paragraph>
            <paragraph>
              <content styleCode="bold">For external use only</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">100 g + 20 g TOTAL NET WT 120 g (4.23 oz)</content>
            </paragraph>
            <renderMultiMedia ID="id-1009514353" referencedObject="ID_542b798a-44d5-4502-b4a7-e1f56cf1e83f"/>
          </text>
          <effectiveTime value="20250211"/>
          <component>
            <observationMedia ID="ID_542b798a-44d5-4502-b4a7-e1f56cf1e83f">
              <text>Voltaren Kit 100 g plus 20 g</text>
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                <reference value="Voltaren Kit 100 g plus 20 g.jpg"/>
              </value>
            </observationMedia>
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